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Vaccines, Volume 13, Issue 2 (February 2025) – 101 articles

Cover Story (view full-size image): The pursuit of an effective HIV-1 vaccine remains a key endeavor in the fight against HIV/AIDS. Despite decades of research, achieving an effective vaccine has proven to be elusive due to several challenges, including the virus's genetic variability, rapid mutation rates, host immune system evasion, and the establishment of latent reservoirs. This report explores the vital progress made in HIV-1 vaccine research, including strides in understanding the biology of the virus and the immune responses it elicits, informing the development of novel vaccine strategies. Furthermore, it addresses the ongoing challenges in each of these vaccine design endeavors. The paper also discusses the future directions and collaborative efforts needed to overcome these obstacles, emphasizing the importance of global cooperation in achieving a successful HIV-1 vaccine. View this paper
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9 pages, 619 KiB  
Article
Early and Late Influenza Vaccine Effectiveness in South Korea During the 2023–2024 Season
by Yu Jung Choi, Joon Young Song, Seong-Heon Wie, Jacob Lee, Jin-Soo Lee, Hye Won Jeong, Joong Sik Eom, Jang Wook Sohn, Won Suk Choi, Eliel Nham, Jin Gu Yoon, Ji Yun Noh, Hee Jin Cheong and Woo Joo Kim
Vaccines 2025, 13(2), 197; https://doi.org/10.3390/vaccines13020197 (registering DOI) - 17 Feb 2025
Abstract
Background: During the 2023–2024 season, the influenza epidemic in South Korea peaked earlier, and the influenza vaccination rate among individuals aged ≥ 65 was high (82.2%). However, data on real-world vaccine effectiveness against influenza are lacking. Methods: From November 2023 to April 2024, [...] Read more.
Background: During the 2023–2024 season, the influenza epidemic in South Korea peaked earlier, and the influenza vaccination rate among individuals aged ≥ 65 was high (82.2%). However, data on real-world vaccine effectiveness against influenza are lacking. Methods: From November 2023 to April 2024, we conducted a multicenter retrospective case–control study on adult patients aged ≥ 18 years who presented with influenza-like illness at seven medical centers as a part of a hospital-based influenza morbidity and mortality surveillance (HIMM) program in South Korea. Demographic and clinical data were collected from questionnaire surveys and electronic medical records. Using a test-negative design, we assessed the effectiveness of the 2023–2024 seasonal influenza vaccine, with age, sex, and comorbidities included as covariates. Results: A total of 3390 participants were enrolled through the HIMM system, including 1695 patients with either rapid antigen test (RAT) or real-time reverse-transcription polymerase chain reaction (RT-PCR) positive results and controls matched for age, sex, and months of registration. Among the 1696 influenza-positive patients, 1584 (93.5%) underwent RAT, with 88.9% testing positive for influenza A and 11.1% for influenza B. During the study periods, the overall vaccine effectiveness (VE) was 24.3% (95% confidence interval (CI), 11.5 to 35.2). The VE was insignificant when limited to older adults aged ≥ 65 years (13.5%; 95% CI, −17.9 to 36.6). In the subgroup analysis by subtype, the VE was 19.0% (95% CI, 5.0 to 31.0) for influenza A and 56.3% (95% CI, 35.3 to 70.6) for influenza B. Notably, influenza VE was 20.4% (95% CI, 2.9 to 34.8) in the early period (November to December) but decreased to 12.4% (95% CI, −14.9 to 33.2) in the late period (January to April). Conclusion: During the 2023–2024 season, the influenza vaccine showed a modest effectiveness (24.3%) against laboratory-confirmed influenza, which was particularly higher for influenza B. Because the VE was insignificant in older adults, particularly during the late period, better immunogenic influenza vaccines with longer-lasting protection should be considered. Full article
(This article belongs to the Special Issue Immune Response After Respiratory Infection or Vaccination)
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15 pages, 2626 KiB  
Article
Porvac® Subunit Vaccine Protects Against Three Field Isolates of Classical Swine Fever Virus
by Yusmel Sordo-Puga, María Pilar Rodríguez-Moltó, Danny Pérez-Pérez, Paula Naranjo-Valdés, Talía Sardina-González, Mary Karla Méndez-Orta, Elaine Santana-Rodríguez, Milagros Vargas-Hernández, Carmen Laura Perera, Carlos A. Duarte and Marisela Suárez-Pedroso
Vaccines 2025, 13(2), 196; https://doi.org/10.3390/vaccines13020196 (registering DOI) - 17 Feb 2025
Abstract
The control of classical swine fever (CSF) in endemic areas has been attempted with modified live vaccines. However, in some regions, the implementation of imperfect vaccination programs has led to a reduction in the genetic diversity of the circulating CSF virus (CSFV) strains [...] Read more.
The control of classical swine fever (CSF) in endemic areas has been attempted with modified live vaccines. However, in some regions, the implementation of imperfect vaccination programs has led to a reduction in the genetic diversity of the circulating CSF virus (CSFV) strains and a change in their virulence. Porvac® subunit vaccine has been shown to provide a rapid onset of protection against the “Margarita” strain. The aim of this study was to evaluate whether the immune response induced by Porvac® is also effective against autochthonous CSFV isolates of low, medium or high virulence. All pigs vaccinated with Porvac® were protected against the disease after challenge. PR-11/10–3 isolate caused a very mild disease in controls, whilst Holguin_2009 isolate produced mild to moderate signs of CSF and one of the pigs died. Finally, controls inoculated with PR-2016 isolate developed moderate to severe signs of CSF and two of them died. Viral replication was detected in controls, but not in pigs immunized with Porvac®. Finally, anti-Erns antibodies were induced in five out of six control pigs but not in any of the vaccinated pigs. These results support the use of Porvac® for the control and elimination of CSF in Cuba and other endemic regions. Full article
(This article belongs to the Special Issue Porcine Virus and Vaccines)
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16 pages, 4008 KiB  
Article
Amonabactin Synthetase G Regulates Aeromonas hydrophila Pathogenicity Through Modulation of Host Wnt/β-catenin Signaling
by Yiyang Tang, Xiaofeng Liu, Chuyi Zeng, Yujun Liu, Ye Yang, Jiayi Hu, Pingyuan Li and Zejun Zhou
Vaccines 2025, 13(2), 195; https://doi.org/10.3390/vaccines13020195 (registering DOI) - 17 Feb 2025
Abstract
Background/Objectives: Aeromonas hydrophila is a significant opportunistic pathogen with a broad host range. It produces a catecholate siderophore, amonabactin, during iron starvation, but the in vivo infection mechanism that involves amonabactin is unclear. This study aims to elucidate the role of amonabactin synthetase [...] Read more.
Background/Objectives: Aeromonas hydrophila is a significant opportunistic pathogen with a broad host range. It produces a catecholate siderophore, amonabactin, during iron starvation, but the in vivo infection mechanism that involves amonabactin is unclear. This study aims to elucidate the role of amonabactin synthetase G (AmoG) in the pathogenicity of A. hydrophila and its impact on gut barrier function. Methods: ΔAmoG was generated by deleting the AMP-binding domain of AmoG in A. hydrophila CCL1. In vivo infection experiments were conducted to assess the mutant’s iron-chelating ability and pathogenicity. Complementation of ΔAmoG with AmoG (ΔAmoG-C) was performed to confirm the observed phenotypes. Transcriptomic and qRT-PCR analyses were used to investigate gene expression changes in infected fish. Goblet cell counts, tight junction expression, and D-lactic acid and LPS levels were measured to evaluate gut barrier function. Results: ΔAmoG exhibited impaired iron-chelating ability and reduced pathogenicity compared to wild-type CCL1. Complementation with AmoG restored virulence in ΔAmoG-C. Transcriptomic and qRT-PCR analyses revealed an elevated expression of Wnt/β-catenin pathway components and antimicrobial genes in ΔAmoG-infected fish. Further investigation indicated increased goblet cells and an enhanced expression of tight junctions, as well as lower D-lactic acid and LPS levels, in ΔAmoG-infected fish. However, gut permeability, bacterial load, and lethality did not significantly differ between CCL1, ΔAmoG, and ΔAmoG-C infections when the Wnt/β-catenin pathway was activated. Conclusions: AmoG plays a crucial role in A. hydrophila pathogenicity by modulating host Wnt/β-catenin signaling and gut mucosal barrier function. This study provides insights into the pathogenesis of A. hydrophila and potential therapeutic targets. Full article
(This article belongs to the Special Issue Fish Disease Occurrence and Immune Prevention and Control)
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13 pages, 2751 KiB  
Article
Sex and Age-Based Differences in Immune Responses to a Peptide Vaccine for Melanoma in Two Clinical Trials
by Serena M. Vilasi and Craig L. Slingluff, Jr.
Vaccines 2025, 13(2), 194; https://doi.org/10.3390/vaccines13020194 (registering DOI) - 16 Feb 2025
Abstract
Objectives: Little is known about the impact of patient age and biological sex on immune responses to melanoma vaccines, especially CD4+ T cell immune responses to peptides presented by Class II MHC molecules. Methods: We assessed the impact of age and sex [...] Read more.
Objectives: Little is known about the impact of patient age and biological sex on immune responses to melanoma vaccines, especially CD4+ T cell immune responses to peptides presented by Class II MHC molecules. Methods: We assessed the impact of age and sex on CD4+ T cell and antibody responses to a mixture of six melanoma helper peptides (6MHP) and on CD8+ T cell responses when vaccinating with 12 class I MHC-restricted melanoma peptides (12MP) plus either 6MHP or a tetanus helper T cell peptide (Tet). We hypothesized that immune responses would be greater in men and in younger patients. Results: We found differences in immune response by sex, but they favored female patients and were only evident for helper T cell responses to Tet with a weak trend to higher T cell responses to 12MP in female patients vaccinated with 12MP + Tet. The age-based differences favored younger patients but only for immune response to 12MP when inoculated with 12MP + Tet. Conclusions: These findings reinforce the importance of assessing sex- and age-based differences in immune responses to cancer vaccines and other immune therapies. There is also a need to understand the reasons for such differences. Full article
(This article belongs to the Section Attenuated/Inactivated/Live and Vectored Vaccines)
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14 pages, 813 KiB  
Review
Innate Sensing of Viral Nucleic Acids and Their Use in Antiviral Vaccine Development
by Takuji Enya and Susan R. Ross
Vaccines 2025, 13(2), 193; https://doi.org/10.3390/vaccines13020193 (registering DOI) - 16 Feb 2025
Abstract
Viruses pose a significant threat to humans by causing numerous infectious and potentially fatal diseases. Understanding how the host’s innate immune system recognizes viruses is essential to understanding pathogenesis and ways to control viral infection. Innate immunity also plays a critical role in [...] Read more.
Viruses pose a significant threat to humans by causing numerous infectious and potentially fatal diseases. Understanding how the host’s innate immune system recognizes viruses is essential to understanding pathogenesis and ways to control viral infection. Innate immunity also plays a critical role in shaping adaptive immune responses induced by vaccines. Recently developed adjuvants often include nucleic acids that stimulate pattern recognition receptors which are essential components of innate immunity necessary for activating antigen-presentation cells and thereby bridging innate and adaptive immunity. Therefore, understanding viral nucleic acid sensing by cytosolic sensors is essential, as it provides the potential means for developing new vaccine strategies, including effective adjuvants. Full article
(This article belongs to the Special Issue Host–Virus Interactions and Vaccine Development)
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18 pages, 2369 KiB  
Article
Safety, Tolerability, and Immunogenicity of the Pneumococcal Vaccines PPSV23 or PCV15 Co-Administered with a Booster Dose of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Adults ≥50 Years of Age
by Tosin Omole, Enrique Pelayo, Aaron S. Weinberg, Spyros Chalkias, Zelalem Endale, Gretchen Tamms, Tina M. Sterling, Lori Good, Tulin Shekar, Morgan Johnson, Natalie Banniettis, Ulrike K. Buchwald and Alejandra Esteves-Jaramillo
Vaccines 2025, 13(2), 192; https://doi.org/10.3390/vaccines13020192 (registering DOI) - 15 Feb 2025
Abstract
Background/Objectives: Streptococcus pneumoniae with, or following, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been associated with increased mortality, particularly in older adults. However, vaccination can be an effective preventative measure. This Phase 3 study (NCT05158140) assessed the immunogenicity and safety of [...] Read more.
Background/Objectives: Streptococcus pneumoniae with, or following, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been associated with increased mortality, particularly in older adults. However, vaccination can be an effective preventative measure. This Phase 3 study (NCT05158140) assessed the immunogenicity and safety of co-administering the SARS-CoV-2 vaccine mRNA-1273 with the 23-valent pneumococcal polysaccharide vaccine (PPSV23) or the 15-valent pneumococcal conjugate vaccine (PCV15). Methods: Participants were healthy adults ≥50 years of age who had previously received a two-dose primary series of mRNA-1273 ≥5 months before the first study visit and may have received a booster dose of mRNA-1273 ≥4 months prior to the first study visit. Participants were randomized (1:1:1:1) to receive mRNA-1273 concomitantly with PPSV23 or PCV15 on Day 1 followed by placebo on Day 30, or sequentially with mRNA-1273 and placebo on Day 1 and PPSV23 or PCV15 on Day 30. The primary study endpoints were pneumococcal-serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) and SARS-CoV-2-specific binding antibody GMTs at 30 days after vaccination, as well as safety and tolerability following vaccination. Results: In total, 850 adults participated in the study. Serotype-specific OPA GMTs at 30 days post-vaccination with PPSV23 or PCV15 were generally comparable between the concomitant and sequential groups. SARS-CoV-2-specific GMTs increased in all groups from pre-vaccination to 30 days post-vaccination with mRNA-1273, with a consistent response between concomitant and sequential groups. Safety profiles were comparable across study groups. Conclusions: Co-administration of mRNA-1273 with PPSV23 or PCV15 in healthy adults ≥50 years of age was immunogenic and well tolerated. Full article
(This article belongs to the Section Vaccine Efficacy and Safety)
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29 pages, 2354 KiB  
Review
Molecular Farming for Immunization: Current Advances and Future Prospects in Plant-Produced Vaccines
by Dang-Khoa Vo and Kieu The Loan Trinh
Vaccines 2025, 13(2), 191; https://doi.org/10.3390/vaccines13020191 (registering DOI) - 15 Feb 2025
Abstract
Using plants as bioreactors, molecular farming has emerged as a versatile and sustainable platform for producing recombinant vaccines, therapeutic proteins, industrial enzymes, and nutraceuticals. This innovative approach leverages the unique advantages of plants, including scalability, cost-effectiveness, and reduced risk of contamination with human [...] Read more.
Using plants as bioreactors, molecular farming has emerged as a versatile and sustainable platform for producing recombinant vaccines, therapeutic proteins, industrial enzymes, and nutraceuticals. This innovative approach leverages the unique advantages of plants, including scalability, cost-effectiveness, and reduced risk of contamination with human pathogens. Recent advancements in gene editing, transient expression systems, and nanoparticle-based delivery technologies have significantly enhanced the efficiency and versatility of plant-based systems. Particularly in vaccine development, molecular farming has demonstrated its potential with notable successes such as Medicago’s Covifenz for COVID-19, illustrating the capacity of plant-based platforms to address global health emergencies rapidly. Furthermore, edible vaccines have opened new avenues in the delivery of vaccines, mainly in settings with low resources where the cold chain used for conventional logistics is a challenge. However, optimization of protein yield and stability, the complexity of purification processes, and regulatory hurdles are some of the challenges that still remain. This review discusses the current status of vaccine development using plant-based expression systems, operational mechanisms for plant expression platforms, major applications in the prevention of infectious diseases, and new developments, such as nanoparticle-mediated delivery and cancer vaccines. The discussion will also touch on ethical considerations, the regulatory framework, and future trends with respect to the transformative capacity of plant-derived vaccines in ensuring greater global accessibility and cost-effectiveness of the vaccination. This field holds great promise for the infectious disease area and, indeed, for applications in personalized medicine and biopharmaceuticals in the near future. Full article
(This article belongs to the Special Issue Production of Plant Virus-Based Vaccines and Therapeutics)
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17 pages, 2141 KiB  
Article
Long-Term Protection in Atlantic Salmon (Salmo salar) to Pancreas Disease (PD) Can Be Achieved Through Immunization with Genetically Modified, Live Attenuated Salmonid Alphavirus 3
by Stine Braaen, Øystein Wessel, Håvard Bjørgen and Espen Rimstad
Vaccines 2025, 13(2), 190; https://doi.org/10.3390/vaccines13020190 (registering DOI) - 15 Feb 2025
Abstract
Background: Pancreas disease (PD) is a serious disease in European salmonid aquaculture caused by salmonid alphavirus (SAV), of which six genotypes (SAV1–6) have been described. The use of inactivated virus and DNA PD vaccines is common in marine salmonid aquaculture and has [...] Read more.
Background: Pancreas disease (PD) is a serious disease in European salmonid aquaculture caused by salmonid alphavirus (SAV), of which six genotypes (SAV1–6) have been described. The use of inactivated virus and DNA PD vaccines is common in marine salmonid aquaculture and has contributed to a reduction of the occurrence of disease; however, outbreaks are still frequent. Methods: In this study, we compared the long-term protection after immunization of Atlantic salmon (Salmo salar) with three different clones of attenuated infectious SAV3. The clones were made by site-directed mutagenesis targeting the glycoprotein E2 to disrupt the viral attachment and/or nuclear localization signal (NLS) of the capsid protein to disrupt the viral suppression of cellular nuclear-cytosol trafficking. The resulting clones (Clones 1–3) were evaluated after injection of Atlantic salmon for infection dynamics, genetic stability, transmission, and protection against a subsequent SAV3 challenge. Results: Attenuated clones demonstrated reduced virulence, as indicated by lower viral RNA loads, diminished transmission to cohabitant fish, and minimal clinical symptoms compared to the virulent wild-type virus. The clones mutated in both capsid and E2 exhibited the most attenuation, observed as rapid clearing of the infection and showing little transmission, while the clone with glycoprotein E2 mutations displayed greater residual virulence but provided stronger protection, seen as reduced viral loads upon subsequent challenge with SAV3. Despite their attenuation, all viral clones caused significant reductions in weight gain. Conclusions: Despite promising attenuation and protection, this study highlights the trade-offs between virulence and immunogenicity in live vaccine design. Concerns over environmental risks, such as the shedding of genetically modified virus, necessitate further evaluation. Future efforts should optimize vaccine candidates to balance attenuation, immunogenicity, and minimal side effects. Full article
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15 pages, 705 KiB  
Article
Safety and Efficacy of Influenza Vaccination in Kidney Graft Recipients in Late Period After Kidney Transplantation
by Anna Zawiasa-Bryszewska, Maja Nowicka, Monika Górska, Piotr Edyko, Krzysztof Edyko, Damian Tworek, Adam Antczak, Jacek Burzyński and Ilona Kurnatowska
Vaccines 2025, 13(2), 189; https://doi.org/10.3390/vaccines13020189 - 14 Feb 2025
Abstract
Background/Objectives: Influenza is a viral infection affecting up to 20% of the general population annually. Solid organ transplant recipients have a higher morbidity and mortality risk, as well as a greater likelihood of severe disease complications. Vaccination against the influenza virus is a [...] Read more.
Background/Objectives: Influenza is a viral infection affecting up to 20% of the general population annually. Solid organ transplant recipients have a higher morbidity and mortality risk, as well as a greater likelihood of severe disease complications. Vaccination against the influenza virus is a safe and recommended prophylaxis; however, immunosuppression and high comorbidity burdens impair the immune response. We assessed the efficacy, safety, and humoral response to influenza vaccine in a population of kidney transplant recipients(KTx). Methods: Adult KTx recipients at least 6 months post-KTx were divided into vaccinated (vKTx) and non-vaccinated (nvKTx) groups based on consent for vaccination. The vKTx group received one dose of quadrivalent split virion inactivated vaccine(Vaxigrip Tetra Sanofi Pasteur). Subjective symptoms and side effects were recorded in paper journals. Antibody levels were assessed with ELISA prior to and 3 months following vaccination. Serum creatinine and proteinuria were assessed prior to vaccination as well as 3 and 6 months after. Results: Of 450 recruited KTx recipients, 91 in the vKTx group and 36 in the nvKTx group of comparable age, KTx vintage, and graft function were included in the study. Graft function and proteinuria remained stable in both groups. The vKTx group experienced no severe adverse events. The most common complaints were general malaise (20.5%) and injection site pain(10.3%). Overall infection rates were comparable, yet the vKTx group experienced significantly fewer serious infections(11.4% vs. 32.3%, p = 0.01); the vKTx group showed a greater increase of Influenza A IgM (p = 0.05) and Influenza B IgG (p = 0.01) compared with the nvKTx group. Conclusions: Influenza vaccination prevents severe infections in KTx recipients, with good serological response and no impact on graft function or severe adverse events. Full article
(This article belongs to the Special Issue Vaccine Efficacy and Safety in Transplant Recipients)
18 pages, 990 KiB  
Article
Generation of Vaccine Candidate Strains That Antigenically Match Classical Swine Fever Virus Field Strains
by Maya Kobayashi, Loc Tan Huynh, Saho Ogino, Lim Yik Hew, Miki Koyasu, Hikaru Kamata, Takahiro Hiono, Norikazu Isoda and Yoshihiro Sakoda
Vaccines 2025, 13(2), 188; https://doi.org/10.3390/vaccines13020188 - 14 Feb 2025
Abstract
Background: Classical swine fever virus (CSFV) is genetically categorized into three genotypes. A live-attenuated vaccine strain GPE, currently used in Japan, belongs to genotype 1 and is genetically distinct from the field strains circulating in Japan, which belong to genotype 2. [...] Read more.
Background: Classical swine fever virus (CSFV) is genetically categorized into three genotypes. A live-attenuated vaccine strain GPE, currently used in Japan, belongs to genotype 1 and is genetically distinct from the field strains circulating in Japan, which belong to genotype 2. This study aimed to understand the antigenicity of recent field isolates in Japan and develop new vaccine candidates that antigenically match field strains. Methods: The serum samples of 20 pigs vaccinated with GPE were subjected to a serum neutralizing test (SNT) using one of the field strains, CSFV/wb/Jpn-Mie/P96/2019 (Mie/2019). For the antigenic matching, vGPE/HiBiT/Mie E2 was generated by replacing the viral glycoprotein E2, the main target of the neutralizing antibody, with that of Mie/2019. Additionally, vGPE/HiBiT/Mie E2/PAPeV Erns was generated by further substituting glycoprotein Erns with that of pronghorn antelope pestivirus (PAPeV) since Erns is not important as a vaccine immunogen and can be replaced by that of other pestiviruses to provide an immunological marker. The efficacy of vGPE/HiBiT/Mie E2/PAPeV Erns was further evaluated by the challenge experiments in pigs. Results: The SNT titers of serum sample against Mie/2019 were 6.1-fold lower than that against vGPE. The generated recombinant viruses showed closer antigenicity to Mie/2019 than vGPE. The challenge study confirmed that vGPE/HiBiT/Mie E2/PAPeV Erns provided clinical and virological protection against a field CSFV equivalent to vGPE. Conclusions: This study demonstrated that swapping the E2 encoding region with the prevalent field CSFVs is a promising strategy to achieve antigenic matching between the vaccine and field strains. Full article
(This article belongs to the Special Issue Porcine Virus and Vaccines)
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21 pages, 1656 KiB  
Article
Cost-Effectiveness of Introducing Nuvaxovid to COVID-19 Vaccination in the United Kingdom: A Dynamic Transmission Model
by Clive Pritchard, Lucie Kutikova, Richard Pitman, Kira Zhi Hua Lai, Hadi Beyhaghi, IIana Gibbons, Amanda Erbe, Marija Živković-Gojović, Catherine Cosgrove, Mark Sculpher and David Salisbury
Vaccines 2025, 13(2), 187; https://doi.org/10.3390/vaccines13020187 - 14 Feb 2025
Abstract
Background/Objectives: Vaccination against SARS-CoV-2 remains a key measure to control COVID-19. Nuvaxovid, a recombinant Matrix-M–adjuvanted protein-based vaccine, showed similar efficacy to mRNA vaccines in clinical trials and real-world studies, with lower rates of reactogenicity. Methods: To support decision making on UK vaccine selection, [...] Read more.
Background/Objectives: Vaccination against SARS-CoV-2 remains a key measure to control COVID-19. Nuvaxovid, a recombinant Matrix-M–adjuvanted protein-based vaccine, showed similar efficacy to mRNA vaccines in clinical trials and real-world studies, with lower rates of reactogenicity. Methods: To support decision making on UK vaccine selection, a population-based compartmental dynamic transmission model with a cost-utility component was developed to evaluate the cost-effectiveness of Nuvaxovid compared with mRNA vaccines from a UK National Health Service perspective. The model was calibrated to official epidemiology statistics for mortality, incidence, and hospitalisation. Scenario and sensitivity analyses were conducted. Results: In the probabilistic base case, a Nuvaxovid-only strategy provided total incremental cost savings of GBP 1,338,323 and 1558 additional quality-adjusted life years (QALYs) compared with an mRNA-only vaccination strategy. Cost savings were driven by reduced cold chain-related operational costs and vaccine wastage, while QALY gains were driven by potential differences in vaccine tolerability. Probabilistic sensitivity analysis indicated an approximately 70% probability of cost-effectiveness with Nuvaxovid-only versus mRNA-only vaccination across most cost-effectiveness thresholds (up to GBP 300,000/QALY gained). Conclusions: Nuvaxovid remained dominant over mRNA vaccines in scenario analyses assessing vaccine efficacy waning, Nuvaxovid market shares, and the vaccinated population. Full article
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2 pages, 1482 KiB  
Correction
Correction: Patel et al. Development and Characterization of an In Vitro Cell-Based Assay to Predict Potency of mRNA–LNP-Based Vaccines. Vaccines 2023, 11, 1224
by Nisarg Patel, Zach Davis, Carl Hofmann, Josef Vlasak, John W. Loughney, Pete DePhillips and Malini Mukherjee
Vaccines 2025, 13(2), 186; https://doi.org/10.3390/vaccines13020186 - 14 Feb 2025
Abstract
The authors would like to make the following corrections to this published paper [...] Full article
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23 pages, 2295 KiB  
Review
Current Development of Therapeutic Vaccines in Lung Cancer
by Jesus Salvador Flores Banda, Sanjana Gangane, Fatima Raza and Erminia Massarelli
Vaccines 2025, 13(2), 185; https://doi.org/10.3390/vaccines13020185 - 14 Feb 2025
Abstract
Cancer vaccines have a potential to change the current landscape of immunotherapy research and development. They target and neutralize specific tumor cells by utilizing the body’s own immune system which offers a promising modality in treating various cancers including lung cancer. Historically, prior [...] Read more.
Cancer vaccines have a potential to change the current landscape of immunotherapy research and development. They target and neutralize specific tumor cells by utilizing the body’s own immune system which offers a promising modality in treating various cancers including lung cancer. Historically, prior vaccination approaches specifically towards lung cancer have posed several challenges but also potential with early phase I/II trials showing improved overall survival. With better understanding of the body’s immune system as well as advancements in vaccine development, the use of vaccines to target lung cancer cells in both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) has shown promise but also challenges in the setting of advanced stage cancers, tumor resistance mechanisms, immune evasion, and tumor heterogeneity. The proposed solution is to enroll patients in the early stages of the disease, rather than waiting until progression occurs. Additionally, future efforts will focus on the targeted identification of specific and novel tumor neo-antigens. This review offers discussion and analysis of both completed and ongoing trials utilizing different strategies for vaccine development in relation to treating lung cancer as well as current challenges faced. Full article
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15 pages, 442 KiB  
Article
Immunosuppressive Treatments and Risk Factors Associated with Non-Response to Hepatitis B Vaccination: A Cohort Study
by Raquel Padilla-Matas, Victoria Salguero-Cano, Eva Soler-Iborte, Javier Baca-Hidalgo, Marta Pérez-Dionisio, Soledad Gutiérrez-Linares, Inmaculada Guerrero-Fernández de Alba, María del Carmen Valero-Ubierna, María Fernández-Prada and Mario Rivera-Izquierdo
Vaccines 2025, 13(2), 184; https://doi.org/10.3390/vaccines13020184 - 14 Feb 2025
Abstract
Background: The aim of this study was to evaluate the serological response after the complete hepatitis B vaccination of patients according to the immunosuppressive treatment they underwent, and to identify potential factors associated with non-responders. Methods: A prospective cohort study was [...] Read more.
Background: The aim of this study was to evaluate the serological response after the complete hepatitis B vaccination of patients according to the immunosuppressive treatment they underwent, and to identify potential factors associated with non-responders. Methods: A prospective cohort study was conducted, and patients under immunosuppressive therapies were considered exposed. The main outcome was non-response to hepatitis B vaccination. Bivariate analysis was conducted to detect differences between exposed and non-exposed patients. A multivariable log-binomial regression model was designed to analyze potential factors independently associated with non-responders. Results: A total of 289 patients were included. Immunosuppressive treatment was associated with non-response to hepatitis B vaccination (RR = 2.49, 95% CI: 1.26–4.96). Concretely, the use of cytotoxic therapies showed increased risk, although anti-CD20 and anti-JAK also showed a tendency to be associated with non-responders. Other variables associated with non-responders were older age (6–7% higher risk per year), smoking (RR = 3.08, 95% CI: 1.41–6.74) and certain vaccine regimens. These findings were similar for persistent non-responders despite an additional booster dose. Conclusions: Patients receiving immunosuppressive treatments, who are older in age or who are smokers have a higher risk of non-response to conventional hepatitis B vaccination. These data might serve to optimize hepatitis B vaccination in high-risk patients. Full article
(This article belongs to the Special Issue Vaccination Strategies for Global Public Health)
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13 pages, 2564 KiB  
Systematic Review
Prevalence of Mpox Vaccine Acceptance Among Students: A Systematic Review and Meta-Analysis
by Ambanna Yappalparvi, Shilpa Gaidhane, G. Padmapriya, Irwanjot Kaur, Madan Lal, Suhaib Iqbal, G. V. Siva Prasad, Atreyi Pramanik, Promila Sharma, Praveen Malik, Teena Vishwakarma, Ankit Punia, Megha Jagga, Rachana Mehta, Sanjit Sah, Muhammed Shabil, Prakasini Satapathy, Ganesh Bushi, Ali Davod Parsa and Russell Kabir
Vaccines 2025, 13(2), 183; https://doi.org/10.3390/vaccines13020183 - 13 Feb 2025
Abstract
Background: Mpox, formerly known as monkeypox, is a re-emerging viral disease. Vaccine acceptance is crucial for preventing its spread. This systematic review and meta-analysis assessed the acceptance of the Mpox vaccine among student populations. Methods: We searched electronic databases, including PubMed, Web of [...] Read more.
Background: Mpox, formerly known as monkeypox, is a re-emerging viral disease. Vaccine acceptance is crucial for preventing its spread. This systematic review and meta-analysis assessed the acceptance of the Mpox vaccine among student populations. Methods: We searched electronic databases, including PubMed, Web of Science, and Embase, up to 14 September 2024. The studies included were observational, such as cross-sectional and cohort studies, and specifically assessed vaccine acceptance for Mpox vaccines among students. R version 4.4 was used to perform the meta-analysis, and sensitivity analyses were conducted to assess the robustness of the findings. The publication bias was evaluated using Doi plots. Results: Of the 143 studies initially identified, eight studies were included in the final analysis, comprising a total of 16,129 participants. The overall vaccine acceptance rate was 58.6%, with considerable variability across studies (I2 = 100%). The sensitivity analyses indicated that acceptance rates ranged between 45% and 70%. The Doi plot demonstrated the presence of moderate publication bias. Conclusion: This systematic review and meta-analysis shows moderate acceptance of the Mpox vaccine among students. Future studies should investigate the factors influencing vaccine acceptance and design targeted strategies to improve coverage, which will be essential for controlling Mpox and ensuring successful vaccination campaigns. Full article
(This article belongs to the Special Issue Vaccines against Mpox: Combating the Threat)
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36 pages, 2117 KiB  
Review
HDAC3: A Multifaceted Modulator in Immunotherapy Sensitization
by Rui Han, Yujun Luo, Jingdong Gao, Huiling Zhou, Yuqian Wang, Jiaojiao Chen, Guoyin Zheng and Changquan Ling
Vaccines 2025, 13(2), 182; https://doi.org/10.3390/vaccines13020182 - 13 Feb 2025
Abstract
Histone deacetylase 3 (HDAC3) has emerged as a critical epigenetic regulator in tumor progression and immune modulation, positioning it as a promising target for enhancing cancer immunotherapy. This work comprehensively explores HDAC3’s multifaceted roles, focusing on its regulation of key immune-modulatory pathways such [...] Read more.
Histone deacetylase 3 (HDAC3) has emerged as a critical epigenetic regulator in tumor progression and immune modulation, positioning it as a promising target for enhancing cancer immunotherapy. This work comprehensively explores HDAC3’s multifaceted roles, focusing on its regulation of key immune-modulatory pathways such as cGAS-STING, ferroptosis, and the Nrf2/HO-1 axis. These pathways are central to tumor immune evasion, antigen presentation, and immune cell activation. Additionally, the distinct effects of HDAC3 on various immune cell types—including its role in enhancing T cell activation, restoring NK cell cytotoxicity, promoting dendritic cell maturation, and modulating macrophage polarization—are thoroughly examined. These findings underscore HDAC3’s capacity to reshape the tumor immune microenvironment, converting immunologically “cold tumors” into “hot tumors” and thereby increasing their responsiveness to immunotherapy. The therapeutic potential of HDAC3 inhibitors is highlighted, both as standalone agents and in combination with immune checkpoint inhibitors, to overcome resistance and improve treatment efficacy. Innovative strategies, such as the development of selective HDAC3 inhibitors, advanced nano-delivery systems, and integration with photodynamic or photothermal therapies, are proposed to enhance treatment precision and minimize toxicity. By addressing challenges such as toxicity, patient heterogeneity, and resistance mechanisms, this study provides a forward-looking perspective on the clinical application of HDAC3 inhibitors. It highlights its significant potential in personalized cancer immunotherapy, paving the way for more effective treatments and improved outcomes for cancer patients. Full article
(This article belongs to the Special Issue Advances in Immunotherapy for T Cells and Tumors)
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11 pages, 1341 KiB  
Article
Plasma microRNAs to Select Optimal Patients for Antibody Production from Anti-Addiction Vaccines
by Thomas R. Kosten, Amrit Koirala, David A. Nielsen, Coreen B. Domingo, Ynhi T. Thomas, Preethi H. Gunaratne and Cristian Coarfa
Vaccines 2025, 13(2), 181; https://doi.org/10.3390/vaccines13020181 - 13 Feb 2025
Abstract
Background: Cocaine and illicit amphetamines (disguised as “Adderall”) are being laced with fentanyl and producing accidental and intentional fatal overdoses. Vaccines can prevent these overdoses, but 33% of humans generate insufficient anti-drug antibody (AB) levels. Plasma microRNAs (miRs) can be used to [...] Read more.
Background: Cocaine and illicit amphetamines (disguised as “Adderall”) are being laced with fentanyl and producing accidental and intentional fatal overdoses. Vaccines can prevent these overdoses, but 33% of humans generate insufficient anti-drug antibody (AB) levels. Plasma microRNAs (miRs) can be used to predict non-responders. We have plasma stored from 152 cocaine vaccine trial participants following three vaccinations over 9 weeks and examined miRs as potential response biomarkers. Methods: We compared 2517 miRs before anti-cocaine vaccination in participants with the highest (n = 25) to the lowest (n = 23) antibody levels. False Discovery Rates (FDRs) were applied to identify differentially expressed (DE) miRs. We used miR target prediction pipelines to identify the miR-regulated genes. Results: Using a DE-FDR < 0.05 and a >3-fold difference between high- and low-AB responders yielded 12 miRs down and 3 miRs up compared to low-AB patients. Furthermore, 11 among 1673 genes were targeted by 3 or more of the 12 down DE-miRs. Conclusions: A significant DE-miR for identifying optimal antibody responders replicated previous vaccine study predictors (miR-150), and several more miRs appear to be strong candidates for future consideration in replications based upon significance of individual DE-miRs and upon multiple miRs converging on individual genes. Full article
(This article belongs to the Section Vaccine Efficacy and Safety)
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10 pages, 457 KiB  
Article
Novel Standard Substance from Primary Hamster Kidney Cells for Quality Control of Human Rabies Vaccines in China
by Leitai Shi, Jia Li, Xiaohong Wu, Shouchun Cao, Yunpeng Wang, Danhua Zhao and Yuhua Li
Vaccines 2025, 13(2), 180; https://doi.org/10.3390/vaccines13020180 - 13 Feb 2025
Abstract
Background: Host cell proteins (HCPs) from primary hamster kidney cells (PHKCs) used to produce rabies vaccines may cause an allergic reaction in humans, so these residual HCPs must be controlled. Establishing a national standard for PHKC HCP is very important to ensure the [...] Read more.
Background: Host cell proteins (HCPs) from primary hamster kidney cells (PHKCs) used to produce rabies vaccines may cause an allergic reaction in humans, so these residual HCPs must be controlled. Establishing a national standard for PHKC HCP is very important to ensure the consistency of HCPs between batches of the vaccine and to standardize the control of HCPs. Objectives: We aimed to establish a novel national standard substance to determine the HCP residue in rabies vaccines produced with PHKCs. Methods: A two-step multi-laboratory collaborative collaboration was undertaken. In the first step, the protein concentration of the standard substance stock solution was determined using Lowry’s method. In the second step, the concentration of the candidate standard substance was determined with an enzyme-linked immunosorbent assay. Results: The concentration of the PHKC protein standard was 4.0 μg/mL (95% confidence interval: 3.5–4.4 μg/mL). Conclusions: The PHKC protein standard was approved by the Chinese National Committee on Standards for the quality control of PHKC-based rabies vaccines for human use, and it plays an important role in controlling the quality of these human vaccines. Full article
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27 pages, 2692 KiB  
Review
Leveraging Electron Beam (eBeam) Technology for Advancing the Development of Inactivated Vaccines
by Ruvindu Perera, Suresh D. Pillai, Adnan Alrubaye and Palmy Jesudhasan
Vaccines 2025, 13(2), 179; https://doi.org/10.3390/vaccines13020179 - 13 Feb 2025
Abstract
This review provides an overview of electron beam (eBeam) technology and its applications across a wide variety of disciplines. More importantly, it discusses this technology’s advantages and its benefits in developing inactivated vaccines. eBeam technology is currently being used all around the world [...] Read more.
This review provides an overview of electron beam (eBeam) technology and its applications across a wide variety of disciplines. More importantly, it discusses this technology’s advantages and its benefits in developing inactivated vaccines. eBeam technology is currently being used all around the world for a variety of industrial applications, extending from food pasteurization to the cross-linking of polymers in the wire and cable industries. It is a successful emerging alternative for developing vaccines against bacterial, protozoan, and viral pathogens. This review includes a descriptive account of the mechanism of action of eBeam and how this technology achieves the complete inactivation of pathogens while retaining the integrity of their surface epitopes. This unique advantage is crucial for the production of efficacious vaccines. This review provides a detailed account of the usage of eBeam technology for developing vaccines to protect a multitude of hosts against a wide range of pathogens. eBeam-inactivated vaccines are advantageous over live vaccines, RNA/subunit vaccines, and chemically inactivated vaccines mainly due to the complete inactivation of pathogens, and the presence of intact, highly antigenic epitopes. To conclude, this article descriptively highlights eBeam technology’s advantages over other means of vaccine development. Full article
(This article belongs to the Special Issue Novel Vaccines and Vaccine Technologies for Emerging Infections)
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15 pages, 4481 KiB  
Article
In Situ Tumor Vaccination Using Lipid Nanoparticles to Deliver Interferon-β mRNA Cargo
by Kenji Kimura, Aidan Aicher, Emma Niemeyer, Phurin Areesawangkit, Caitlin Tilsed, Karen P. Fong, Tyler E. Papp, Steven M. Albelda, Hamideh Parhiz and Jarrod D. Predina
Vaccines 2025, 13(2), 178; https://doi.org/10.3390/vaccines13020178 - 13 Feb 2025
Abstract
Background: In situ cancer vaccination is a therapeutic approach that involves stimulating the immune system in order to generate a polyclonal, anti-tumor response against an array of tumor neoantigens. Traditionally, in situ vaccination approaches have utilized adenoviral vectors to deliver immune-stimulating genes directly [...] Read more.
Background: In situ cancer vaccination is a therapeutic approach that involves stimulating the immune system in order to generate a polyclonal, anti-tumor response against an array of tumor neoantigens. Traditionally, in situ vaccination approaches have utilized adenoviral vectors to deliver immune-stimulating genes directly to the tumor microenvironment. Lipid nanoparticle (LNP)-mediated delivery methods offer several advantages over adenoviral delivery approaches, including increased safety, repeated administration potential, and enhanced tumor microenvironment activation. Methods: To explore in situ vaccination using LNPs, we evaluated LNP-mediated delivery of a reporter gene, mCherry, and an immune-stimulating gene, IFNβ, in several in vitro and in vivo models of lung cancer. Results: In vitro experiments demonstrated successful transfection of murine cancer cell lines with LNPs carrying both mCherry and IFN-β mRNA, resulting in high expression levels and IFNβ production. In vivo studies using LLC.ova flank tumors showed that intratumoral injection of IFNβ-mRNA LNPs led to significant IFNβ production within the tumor microenvironment, with minimal systemic exposure. Therapeutic efficacy was evaluated by injecting established LLC.ova flank tumors with IFNβ-mRNA LNPs bi-weekly for two weeks. Treated tumors showed significant growth inhibition compared to controls. Flow cytometric analysis of tumor-infiltrating leukocytes revealed that tumors injected with IFNβ-mRNA LNPs were associated with an increased CD8:CD4 T-cell ratio among lymphocytes, more CD69-expressing CD8 T-cells, and an increased presence of M1 macrophages. Efficacy and an abscopal effect were confirmed in a squamous cell carcinoma model, MOC1. No toxicity was observed. Conclusions: These findings show that intratumoral LNP delivery of immune-stimulating mRNA transcripts, such as IFNβ, can effectively stimulate local anti-tumor immune responses and warrants further investigation as a potential immunotherapeutic approach for cancer. Full article
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15 pages, 977 KiB  
Article
The Efficacy and Safety of Simultaneous Vaccination with Polysaccharide Conjugate Vaccines Against Pneumococcal (13-Valent Vaccine) and Haemophilus influenzae Type b Infections in Children with Juvenile Idiopathic Arthritis Without Systemic Manifestations: A Prospective Cohort Study
by Ekaterina Alexeeva, Tatyana Dvoryakovskaya, Anna Fetisova, Ivan Kriulin, Elizaveta Krekhova, Anna Kabanova, Vladimir Labinov, Elizaveta Labinova and Mikhail Kostik
Vaccines 2025, 13(2), 177; https://doi.org/10.3390/vaccines13020177 - 12 Feb 2025
Abstract
Background: Immunosuppressive therapy (methotrexate and biological agents) for juvenile idiopathic arthritis (JIA) is associated with an increased risk of severe infections, higher infection rates, treatment interruptions, failure to achieve disease remission, and recurrent disease flares. Our study aimed to evaluate the safety [...] Read more.
Background: Immunosuppressive therapy (methotrexate and biological agents) for juvenile idiopathic arthritis (JIA) is associated with an increased risk of severe infections, higher infection rates, treatment interruptions, failure to achieve disease remission, and recurrent disease flares. Our study aimed to evaluate the safety and efficacy of simultaneous immunization with 13-valent polysaccharide conjugate vaccines (PCV13) against S. pneumoniae (SP) and Hemophilus influanzae type b infections (HibV) in children with JIA without systemic manifestations. Methods: A total of 371 non-systemic JIA patients who received 13PCV and HibV were included in this prospective cohort study. In every patient, we evaluated clinical, laboratory, anti-SP, and anti-Hib IgG antibodies before vaccination, three weeks after, and six months after, and all adverse events (AEs) were collected during the study. The number and duration of acute respiratory infection (ARI) episodes and requirements for antibacterial treatment and AE six months before and after the baseline were collected. Results: The levels of the Ig G anti-SP and anti-Hib antibodies increased in the 3 weeks after vaccination; then, anti-SP antibodies slightly decreased and anti-Hib antibodies remained increased during the whole study, as well as in a part of the patients with a protective titer. During the study, there were no patients with significant flares, and the main JIA outcomes gradually decreased during the trial. The number of patients with uveitis remained equal, as well as the part of the patients with active, low-active, and inactive uveitis. There was no significant rise in the hs-CRP or S100 protein after the vaccination. Previous or ongoing treatment with non-biological (p = 0.072) and biological (p = 0.019) disease-modified anti-rheumatic drugs affected the Hib and did not affect the anti-SP protective titer at the end of the study. Within 6 months following vaccination, the number of ARI episodes (p < 0.001) and the number of courses of antibacterial treatment (p < 0.0001) decreased twice. The median duration of ARI episodes decreased four times (p < 0.0001). Mild AEs (injection site reactions and short-term fever episodes) were found in 58 (15.6%) patients with JIA, and 1 patient (0.2%) developed an SAE. Conclusions: Simultaneous vaccination against pneumococcal and Hib infections reduces the frequency and duration of episodes of ARI, as well as the number of courses of antibacterial drugs, and does not lead to significant JIA flares. The number of reported AEs is consistent with what was expected. Full article
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9 pages, 202 KiB  
Article
COVID-19 Vaccination and Acute Anterior Uveitis—A Case Control Study
by Asaf Shemer, Amit Toledano, Aya Altarescu, Biana Dubinsky-Pertzov, Assaf Rozenberg, Idan Hecht, Adi Einan-Lifshitz and Eran Pras
Vaccines 2025, 13(2), 176; https://doi.org/10.3390/vaccines13020176 - 12 Feb 2025
Abstract
Objective: To evaluate the association between the BNT162b2 (Pfizer-BioNTech®) coronavirus disease vaccine and new-onset anterior uveitis. Methods: A retrospective case control study of patients admitted and diagnosed with new-onset acute anterior uveitis, and matched controls admitted for other reasons (1:3 ratio), [...] Read more.
Objective: To evaluate the association between the BNT162b2 (Pfizer-BioNTech®) coronavirus disease vaccine and new-onset anterior uveitis. Methods: A retrospective case control study of patients admitted and diagnosed with new-onset acute anterior uveitis, and matched controls admitted for other reasons (1:3 ratio), was completed. Rates of exposure to the BNT162b2 vaccine were compared between groups, and odds ratios for exposure to the vaccine were calculated. A secondary analysis of the overall number of patients with new-onset anterior uveitis in the six preceding years was conducted. This study was conducted in one academic center in Israel. Results: A total of 16 patients were admitted for acute anterior uveitis during the study period. Of the 16 cases, 11 (69%) received the first dose of the BNT162b2 vaccine prior to presentation and 8 (50%) also received the second dose. This compares to 39 (81.2%) in the control group. The odds ratio for exposure to the vaccine among cases was 0.508 (95% confidence interval 0.141–1.829, p = 0.300). Compared with preceding years, the rate of cases diagnosed with acute anterior uveitis in 2021 was similar to the six preceding years (mean 11.8 ± 3.4 cases). Conclusions: In this case control study and comparison with preceding years, we found no evidence to suggest an association between vaccination with the BNT162b2 (Pfizer-BioNTech®) COVID-19 vaccine and new-onset acute anterior uveitis. Full article
14 pages, 1050 KiB  
Article
Nirsevimab Prophylaxis for Reduction of Respiratory Syncytial Virus Complications in Hospitalised Infants: The Multi-Centre Study During the 2023–2024 Season in Andalusia, Spain (NIRSEGRAND)
by David Moreno-Pérez, Aleksandra Korobova, Francisco de Borja Croche-Santander, Ana Cordón-Martínez, Olga Díaz-Morales, Leticia Martínez-Campos, Elena Pérez-González, María del Carmen Martínez-Padilla, Juan Luis Santos-Pérez, Jaime Brioso-Galiana, María Isabel Sánchez-Códez, Jorge Del Diego-Salas, Mario Rivera-Izquierdo and Nicola Lorusso
Vaccines 2025, 13(2), 175; https://doi.org/10.3390/vaccines13020175 - 12 Feb 2025
Abstract
Background: Nirsevimab was indicated in a population level for all infants < 6 months during the 2023–2024 season in Andalusia (southern Spain). Our aim was to analyse the effect of nirsevimab in the reduction in complications in infants hospitalised for RSV bronchiolitis. Methods: [...] Read more.
Background: Nirsevimab was indicated in a population level for all infants < 6 months during the 2023–2024 season in Andalusia (southern Spain). Our aim was to analyse the effect of nirsevimab in the reduction in complications in infants hospitalised for RSV bronchiolitis. Methods: A retrospective observational cohort study was conducted in nine relevant hospitals from all provinces of Andalusia, a region with over 9 million inhabitants. The study sample included 222 children, divided into two groups: infants administered with nirsevimab for passive immunisation (exposure) and infants not administered with nirsevimab. Clinical outcomes were analysed, including the use of respiratory support, the need for admission to paediatric intensive care unit (PICU), and duration of hospitalisation. Bivariate analyses were performed, and multivariable logistic regression models were designed to calculate adjusted odds ratios (ORa), and Cox regression models to calculate adjusted hazard ratios (HRa). Results: Bivariate analysis showed an association between passive immunisation with nirsevimab and a lower frequency of numerous outcomes. After adjustment for relevant covariates, multivariable models showed that the exposure (nirsevimab) reduced nasal cannula use by 64% (13–85%), invasive or non-invasive mechanical ventilation by 48% (1–73%), PICU admission by 54% (14–75%), length of hospitalisation by 30% (8–47%), and length of nasal cannula by 31% (7–49%). A higher risk of co-infection was observed in those immunised (aOR = 3.42, 95%CI: 1.52–7.68). Conclusions: Passive immunisation with nirsevimab may decrease the severity of RSV bronchiolitis in infants requiring hospitalisation, thus contributing tertiary prevention that extends beyond the prevention of RSV infection. Full article
(This article belongs to the Collection Research on Monoclonal Antibodies and Antibody Engineering)
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13 pages, 1586 KiB  
Article
Increasing Prevalence of Occult HBV Infection in Adults Vaccinated Against Hepatitis B at Birth
by Ge Zhong, Zhi-Hua Jiang, Xue-Yan Wang, Qin-Yan Chen, Lu-Juan Zhang, Li-Ping Hu, Mei-Lin Huang, Yu-Bi Huang, Xue Hu, Wei-Wei Zhang, Tim J. Harrison and Zhong-Liao Fang
Vaccines 2025, 13(2), 174; https://doi.org/10.3390/vaccines13020174 - 12 Feb 2025
Abstract
Background/Objectives: Immunization with the hepatitis B vaccine is the most effective means of preventing acute HBV infection. However, whether the primary vaccination of infants confers lifelong immunity remains controversial. Therefore, the ongoing surveillance of vaccine recipients is required. Methods: A longitudinal study was [...] Read more.
Background/Objectives: Immunization with the hepatitis B vaccine is the most effective means of preventing acute HBV infection. However, whether the primary vaccination of infants confers lifelong immunity remains controversial. Therefore, the ongoing surveillance of vaccine recipients is required. Methods: A longitudinal study was carried out based on LongAn county, one of the five clinical trial centers for hepatitis B immunization in China in the 1980s. Serum samples were collected and tested for HBV serological markers and DNA. Results: A total of 637 subjects born in 1987–1993 were recruited, including 503 males and 134 females. The total prevalence of HBsAg was 3.9%. The prevalence in females (8.2%) was significantly higher than that in males (2.8%) (p = 0.004). The prevalence of anti-HBc in females (52.2%) was also significantly higher than that in males (41.2%) (p = 0.021). The prevalence of anti-HBs was 42.7% and did not differ significantly between males (41.7%) and females (46.3%) (p = 0.347). Compared to data from surveillance over the last ten years, the positivity rate of HBsAg did not increase. The positivity rate of anti-HBs decreased significantly (p = 0.049) while that of anti-HBc increased significantly (p = 0.001). The prevalence of occult HBV infection (OBI) in 2024 (6.0%) was significantly higher than that in 2017 (1.6%) (p = 0.045). Subjects diagnosed with OBI in 2017 maintained occult infection in 2024. Conclusions: Neonatal HBV vaccination maintained effective protection for at least 37 years. However, the prevalence of OBI increases with age in those vaccinated at birth, raising a new issue of how to prevent and control OBI in the post-universal infant vaccination era. Full article
(This article belongs to the Section Hepatitis Virus Vaccines)
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12 pages, 3816 KiB  
Article
Effect of Inoculation Volume on a Mouse Model of Influenza Virus Infected with the Same Viral Load
by Yali Sun, Yuwei Wei, Xuelian Han, Yuan Wang, Qi Yin, Yuhang Zhang, Tiantian Yang, Jiejie Zhang, Keyu Sun, Feimin Fang, Shuai Zhang, Kai Yuan, Min Li and Guangyu Zhao
Vaccines 2025, 13(2), 173; https://doi.org/10.3390/vaccines13020173 - 12 Feb 2025
Abstract
Background: Influenza is a highly contagious respiratory disease that poses significant health and economic burdens. Mice are commonly used as animal models for studying influenza virus pathogenesis and the development of vaccines and drugs. However, the viral volume used for nasal inoculation varies [...] Read more.
Background: Influenza is a highly contagious respiratory disease that poses significant health and economic burdens. Mice are commonly used as animal models for studying influenza virus pathogenesis and the development of vaccines and drugs. However, the viral volume used for nasal inoculation varies substantially in reported mouse influenza infection models, and the appropriate viral dose is crucial for reproducing experimental results. Methods: Mice were inoculated with mouse lung-adapted strains of influenza virus A/Puerto Rico/8/34 (H1N1) via intranasal administration of 10 μL, 20 μL, and 40 μL at doses of 200 plaque-forming units (PFU) and 2000 PFU. This study investigated the impact of varying viral inoculum volumes on murine outcomes at identical doses and assessed the disparities across diverse dosage levels. Results: Regarding weight change trajectories, mortalities, lung tissue viral titers, and pathological manifestations, the group that received the 40 μL inoculation volume within the low-dose infection mice (200 PFU) manifested a statistically significant divergence from those inoculated with both the 10 μL and 20 μL volumes. Within the context of high-dose infections (2000 PFU), groups that received inoculation volumes of 20 μL and 40 μL exhibited marked disparities when compared to those receiving the 10 μL volume. Conclusions: Disparities in inoculation volume, even under uniform infection dosages, engender differential outcomes in pathogenicity. Of particular note, the viral replication efficacy at a 20 μL inoculation volume demonstrates conspicuous fluctuations across diverse infection dose regimens. Full article
(This article belongs to the Special Issue Viral Infections, Host Immunity and Vaccines)
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18 pages, 942 KiB  
Article
Human Papillomavirus Infection in Partners of Women Attending Cervical Cancer Screening: A Pilot Study on Prevalence, Distribution, and Potential Use of Vaccines
by Arianna Sucato, Nicola Serra, Michela Buttà, Leonardo Di Gregorio, Daniela Pistoia and Giuseppina Capra
Vaccines 2025, 13(2), 172; https://doi.org/10.3390/vaccines13020172 - 11 Feb 2025
Abstract
Background/Objectives: Human Papillomavirus (HPV) cross-infection among couple’s partners is a widespread event and could lead to persistent infections. Unfortunately, the influence of male sexual partners of HPV-positive women on their cervical lesions and the potential role of HPV vaccines have been under-investigated. [...] Read more.
Background/Objectives: Human Papillomavirus (HPV) cross-infection among couple’s partners is a widespread event and could lead to persistent infections. Unfortunately, the influence of male sexual partners of HPV-positive women on their cervical lesions and the potential role of HPV vaccines have been under-investigated. We evaluated the HPV prevalence in male partners of HPV-infected women, focusing on the possible correlation between partners’ cervical lesions and the role of HPV vaccination. Methods: Two samples, genital and urethral swabs, were collected for each of the 90 patients recruited. HPV-DNA detection was carried out by the Allplex HPV28 detection assay. Results: HPV prevalence was 66.7% (60/90); high-risk HPV (hrHPV) genotypes were detected in 90% (54/60) cases and multiple infections in 55% (33/60). The most frequent hrHPVs were HPV31 (p = 0.0265) and HPV52 (p = 0.002), found in 18.3% (11/60) of cases, and HPV53 (p = 0.0116) in 16.7% (10/60). Statistical analysis showed a higher probability of a less severe cytological diagnosis with the increase in the number of genotypes detected (p = 0.0146). Among the HPV-positive partners of females with cervical lesions, 18.7% (6/32) and 62.5% (20/32) had vaccine genotypes of the quadrivalent and nonavalent vaccines, respectively. The nonavalent vaccine showed a significantly higher potential to prevent lesions (62.5% vs. 18.7%, p = 0.0001), with an absolute additional potential impact (AAI) of 31.1% in histological and 32.4% in cytological diagnoses. Conclusions: These preliminary results provide new insight into the correlation between the number of partner genotypes and the severity of cervical lesions and show promising results for the preventive potential of vaccinating male partners. Full article
(This article belongs to the Section Human Papillomavirus Vaccines)
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17 pages, 4803 KiB  
Article
Adherence to Palivizumab for Respiratory Syncytial Virus Prophylaxis in Romanian Infants
by Andreea Calomfirescu-Avramescu, Adrian Ioan Toma, Claudia Mehedințu, Leonard Năstase and Vlad Dima
Vaccines 2025, 13(2), 171; https://doi.org/10.3390/vaccines13020171 - 10 Feb 2025
Abstract
Background: In 2022, Romania started an RSV immunoprophylaxis program with Palivizumab for infants at high risk: preterm infants born before 35 weeks of pregnancy, infants born with congenital heart defects, and infants with chronic lung disease. We evaluated treatment adherence from August 2022 [...] Read more.
Background: In 2022, Romania started an RSV immunoprophylaxis program with Palivizumab for infants at high risk: preterm infants born before 35 weeks of pregnancy, infants born with congenital heart defects, and infants with chronic lung disease. We evaluated treatment adherence from August 2022 to March 2024. Method: We monitored the increase in the number of patients enrolled in the program and the number of collaborating neonatologists, family doctors, and pediatricians. Adherence to all doses of Palivizumab in enrolled patients was assessed by telephone interviews. The factors contributing to reduced adherence were identified. Results: Between August 2022 and March 2024, 1903 patients and 233 specialists were enrolled, a steady increase in both cohorts. The percentage of patients that complete their full sequence of doses decreases along with the number of doses (99% for one dose, 73% for two doses, 47% for three doses, 35% for four doses, and 22% for five doses) due to several factors. Conclusions: The program remains highly regarded by both physicians and caregivers, demonstrating its effectiveness as a valuable resource for educating parents and facilitating monoclonal antibody administration as a prevention method for RSV. Full article
(This article belongs to the Collection Research on Monoclonal Antibodies and Antibody Engineering)
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12 pages, 1018 KiB  
Article
The Humoral Immune Response Against COVID-19 Through Vaccination in Hemodialysis Patients
by Ji Young Park, Seong-Ho Choi, Yong Kwan Lim, Jungho Shin, Soie Kwon, Haein Kim and Jin-Won Chung
Vaccines 2025, 13(2), 170; https://doi.org/10.3390/vaccines13020170 - 10 Feb 2025
Abstract
Background: This study investigated the humoral responses to SARS-CoV-2 in hemodialysis (HD) patients. The clearance of molecules in the blood during hemodialysis is influenced by factors such as filter pore size, flow rate, operating pressure, and treatment duration. Chronic kidney disease patients often [...] Read more.
Background: This study investigated the humoral responses to SARS-CoV-2 in hemodialysis (HD) patients. The clearance of molecules in the blood during hemodialysis is influenced by factors such as filter pore size, flow rate, operating pressure, and treatment duration. Chronic kidney disease patients often show low antibody titers for pathogens like pneumococcus, influenza virus, and hepatitis B virus. Methods: In this study, the surrogate virus neutralization test (sVNT) for the wild type (WT) and Omicron variants, as well as spike-specific IgG levels, were measured at two time points (May 2022 and December 2023). Medical records and questionnaires were used to gather participant information. Results: A total of 26 HD patients were enrolled, including 3 on immunosuppressive therapies. A total of 8 patients had COVID-19 during the first sampling, and 19 during the second. The results showed that sVNT levels for WT decreased over time, though positivity remained at 100% during both sampling periods. In contrast, sVNT levels for Omicron increased significantly, with positivity rising from 46.2% to 75.0% (p < 0.05). Spike-specific IgG levels also increased, with positivity improving from 96.2% to 100%. Patients on immunosuppressive therapies had significantly lower sVNT levels for both WT and Omicron in the second period (p < 0.05), though no significant differences were observed during the first period. Conclusion: HD patients, particularly those on immunosuppressive therapies, showed reduced and declining neutralizing responses over time. A meta-analysis of HD patients seems necessary to determine whether all dialysis patients need COVID-19 booster vaccinations, similar to the hepatitis B vaccine, highlighting the need for targeted vaccination strategies. Full article
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19 pages, 4182 KiB  
Article
Efficacy of Inactivated Bivalent SARS-CoV-2 Vaccines Targeting Ancestral Strain (ERAGEM), Delta, and Omicron Variants
by Busra Kaplan, Shaikh Terkis Islam Pavel, Muhammet Ali Uygut, Merve Tunc, Yesari Eroksuz, Ilhami Celik, Esma Eryilmaz Eren, Gulay Korukluoglu, Ates Kara, Aykut Ozdarendeli and Hazel Yetiskin
Vaccines 2025, 13(2), 169; https://doi.org/10.3390/vaccines13020169 - 10 Feb 2025
Abstract
Background/Objectives: The rapid evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to the emergence of variants with enhanced transmissibility and immune evasion, challenging existing vaccines. This study aimed to evaluate the immunogenicity and protective efficacy of inactivated bivalent vaccine formulations [...] Read more.
Background/Objectives: The rapid evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to the emergence of variants with enhanced transmissibility and immune evasion, challenging existing vaccines. This study aimed to evaluate the immunogenicity and protective efficacy of inactivated bivalent vaccine formulations incorporating the ancestral SARS-CoV-2 strain (ERAGEM) with either Delta or Omicron (BA.5) variants. Methods: Bivalent vaccine formulations were prepared using beta-propiolactone-inactivated SARS-CoV-2 antigens and administered to K18-hACE2 transgenic mice. Following prime and booster immunizations, neutralizing antibody titers and viral loads were assessed through ELISA, microneutralization assays, and quantitative PCR. Mice were challenged with the respective variants, and the survival rates, temperature, and body weight changes were monitored for 21 days. Results: Both vaccine formulations elicited significant increases in neutralizing antibody titers post-booster immunization. The ERAGEM + Delta group demonstrated geometric mean titers (GMTs) of 6938.1 and 4935.0 for the ancestral and Delta variants, respectively, while the ERAGEM + Omicron (BA.5) group achieved GMTs of 16,280.7 and 24,215.9 for the ancestral and Omicron (BA.5) variants. Complete survival (100%) was observed in all the vaccinated groups post-challenge, with no detectable viral titers in the lungs and substantial reductions in the nasal turbinate viral loads compared to the unvaccinated controls. Conclusions: The bivalent inactivated vaccines demonstrated strong immunogenicity and complete protection against severe disease in preclinical models. These findings indicate the potential of bivalent vaccine strategies in addressing antigenic diversity and preparing for future pandemics caused by rapidly evolving pathogens. Full article
(This article belongs to the Section COVID-19 Vaccines and Vaccination)
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13 pages, 2305 KiB  
Article
Enhanced and Prolonged Immunogenicity in Mice of Thermally Stabilized Fatty Acid-Conjugated Vaccine Antigen
by Bo Mi Kim, Yeon-Ho Kim, Hai V. Ngo, Hy D. Nguyen, Chulhun Park and Beom-Jin Lee
Vaccines 2025, 13(2), 168; https://doi.org/10.3390/vaccines13020168 - 10 Feb 2025
Abstract
Background/Objectives: Influenza vaccines require good thermal stability without the need for refrigerator storage. Although the fatty acid-conjugated hemagglutinin (Heg) vaccine antigen provides good stability in both solid and liquid states, its therapeutic effectiveness must be validated in vivo. This study aimed to investigate [...] Read more.
Background/Objectives: Influenza vaccines require good thermal stability without the need for refrigerator storage. Although the fatty acid-conjugated hemagglutinin (Heg) vaccine antigen provides good stability in both solid and liquid states, its therapeutic effectiveness must be validated in vivo. This study aimed to investigate the immunogenicity of the thermally stabilized Heg-oleic acid conjugate (HOC) and compare it with native Heg as a reference. Method: To evaluate HOC immunogenicity, an enzyme-linked immunosorbent assay was used to measure hemagglutinin inhibition (HI) titers, serum IgG antibody titers (IgG1, IgG2a), and cytokine secretion levels (IFN-γ, IL-4) in BALB/c mice after intramuscular (IM) injection. Results: Thermally stabilized HOC induced higher and more sustained serum IgG1 and IgG2a responses than the native Heg vaccine antigen. IgG1 is typically associated with a Th2 response, whereas IgG2a is associated with a Th1 response. HOC appeared to enhance both responses, inducing a more balanced immune response. Moreover, HOC antigens stimulate broader immune responses, suggesting stronger and longer-lasting immune memory. The cytokine levels of IFN-γ (2.8-fold) and IL-4 (6-fold) were significantly increased in the HOC-immunized group compared to the Heg group. IFN-γ, a cytokine that activates the Th1 immune response, demonstrated the enhanced ability of HOC to induce a Th1 response. IL-4, a cytokine that promotes the Th2 response, indicated that HOC also strongly induced a Th2 response. The thermal stability of HOC antigens was crucial for maintaining their structural integrity, enabling the continuous exposure to the stable antigen without denaturation. This allows immune cells to recognize stable antigens efficiently and form long-term immune memory. Conclusions: The stability of HOC antigens enhanced the antigen processing efficiency of antigen-presenting cells (APCs) and stimulated immune responses. The fatty acid-conjugated vaccine antigen could provide improved storage stability but also enhance immunogenic efficacy compared to the native antigen, supporting its potential for further applications. Full article
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