Journal Description
Vaccines
Vaccines
is an international, peer-reviewed, open access journal published monthly online by MDPI. The American Society for Virology (ASV) is affiliated with Vaccines and their members receive a discount on the article processing charges.
- Open Access— free for readers, with article processing charges (APC) paid by authors or their institutions.
- High Visibility: indexed within Scopus, SCIE (Web of Science), PubMed, PMC, Embase, CAPlus / SciFinder, and other databases.
- Journal Rank: JCR - Q1 (Immunology) / CiteScore - Q1 (Pharmacology (medical))
- Rapid Publication: manuscripts are peer-reviewed and a first decision is provided to authors approximately 17.6 days after submission; acceptance to publication is undertaken in 3.3 days (median values for papers published in this journal in the first half of 2024).
- Recognition of Reviewers: reviewers who provide timely, thorough peer-review reports receive vouchers entitling them to a discount on the APC of their next publication in any MDPI journal, in appreciation of the work done.
Impact Factor:
5.2 (2023);
5-Year Impact Factor:
4.9 (2023)
Latest Articles
A Pseudovirus Nanoparticle Displaying the Vaccinia Virus L1 Protein Elicited High Neutralizing Antibody Titers and Provided Complete Protection to Mice against Mortality Caused by a Vaccinia Virus Challenge
Vaccines 2024, 12(8), 846; https://doi.org/10.3390/vaccines12080846 - 26 Jul 2024
Abstract
The recent worldwide incidence of mpox infection and concerns about future emerging variants of mpox viruses highlight the need for the development of a new generation of mpox vaccines. To achieve this goal, we utilized our norovirus S nanoparticle vaccine platform to produce
[...] Read more.
The recent worldwide incidence of mpox infection and concerns about future emerging variants of mpox viruses highlight the need for the development of a new generation of mpox vaccines. To achieve this goal, we utilized our norovirus S nanoparticle vaccine platform to produce and evaluate two pseudovirus nanoparticles (PVNPs), S-L1 and S-J1. These PVNPs displayed the L1 neutralizing antigen target of the vaccinia virus and a yet-untested J1 antigen of the mpox virus, respectively, with the aim of creating an effective nanoparticle-based mpox vaccine. Each self-assembled PVNP consists of an inner shell resembling the interior layer of the norovirus capsid and multiple L1 or J1 antigens on the surface. The PVNPs improved the antibody responses toward the displayed L1 or J1 antigens in mice, resulting in significantly greater L1/J1-specific IgG and IgA titers than those elicited by the corresponding free L1 or J1 antigens. After immunization with the S-L1 PVNPs, the mouse sera exhibited high neutralizing antibody titers against the vaccinia virus, and the S-L1 PVNPs provided mice with 100% protection against mortality caused by vaccinia virus challenge. In contrast, the S-J1 PVNPs induced low neutralizing antibody titers and conferred mice weak protective immunity. These data confirm that the L1 protein is an excellent vaccine target and that the readily available S-L1 PVNPs are a promising mpox vaccine candidate worthy of further development.
Full article
(This article belongs to the Special Issue The 3rd Edition: Development of Vaccines Based on Virus-Like Particles)
►
Show Figures
Open AccessArticle
Immunogenicity of an Inactivated Senecavirus A Vaccine with a Contemporary Brazilian Strain in Mice
by
Amanda de Oliveira Barbosa, Danielle Gava, Caroline Tochetto, Leonardo Clasen Ribeiro, Ana Paula Almeida Bastos, Marcos Antônio Zanella Morés, Rejane Schaefer and Marcelo de Lima
Vaccines 2024, 12(8), 845; https://doi.org/10.3390/vaccines12080845 - 26 Jul 2024
Abstract
Senecavirus A (SVA) is a picornavirus that is endemic in swine, causing a vesicular disease clinically indistinguishable from other vesicular diseases, like foot-and-mouth disease. The widespread viral circulation, constant evolution, and economic losses caused to the swine industry emphasize the need for measures
[...] Read more.
Senecavirus A (SVA) is a picornavirus that is endemic in swine, causing a vesicular disease clinically indistinguishable from other vesicular diseases, like foot-and-mouth disease. The widespread viral circulation, constant evolution, and economic losses caused to the swine industry emphasize the need for measures to control the agent. In this study, we evaluated the immunogenicity of a whole-virus-inactivated vaccine using a representative contemporary Brazilian SVA strain in Balb/ByJ mice. The animals were vaccinated with two doses by an intramuscular route. The humoral response induced by the vaccination was evaluated by an in-house ELISA assay for IgG detection. The cellular response was assessed by flow cytometry after in vitro SVA stimulation in splenocyte cultures from vaccinated and non-vaccinated groups. Protection against SVA was assessed in the experimental groups following an oral challenge with the homologous virus. The vaccination induced high levels of IgG antibodies and the proliferation of CD45R/B220+sIgM+, CD3e+CD69+, and CD3e+CD4+CD44+CD62L− cells. These results indicate the immunogenicity and safety of the vaccine formulation in a murine model and the induction of humoral and cellular response against SVA.
Full article
(This article belongs to the Special Issue Porcine Vaccines: Enhancing Health, Productivity, and Welfare)
►▼
Show Figures
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00845/article_deploy/html/images/vaccines-12-00845-g001-550.jpg?1721987219)
Figure 1
Open AccessBrief Report
Comparison of Post-Vaccination Response (Humoral and Cellular) to BNT162b2 in Clinical Cases, Kidney and Pancreas Transplant Recipient with Immunocompetent Subjects over Almost Two Years of Parallel Monitoring
by
Jaroslaw Walory, Iza Ksiazek, Karolina Wegrzynska and Anna Baraniak
Vaccines 2024, 12(8), 844; https://doi.org/10.3390/vaccines12080844 - 26 Jul 2024
Abstract
Background: Vaccination is one of the most effective medical interventions to prevent infectious diseases. The introduction of vaccines against coronavirus acute respiratory syndrome 2 (SARS-CoV-2) was aimed at preventing severe illness and death due to coronavirus disease 2019 (COVID-19). Solid organ transplant recipients
[...] Read more.
Background: Vaccination is one of the most effective medical interventions to prevent infectious diseases. The introduction of vaccines against coronavirus acute respiratory syndrome 2 (SARS-CoV-2) was aimed at preventing severe illness and death due to coronavirus disease 2019 (COVID-19). Solid organ transplant recipients (SOTRs) are at high risk of infection with SARS-CoV-2 and serious effects associated with COVID-19, mainly due to the use of immunosuppressive therapies, which further cause suboptimal response to COVID-19 vaccination. Aim of the study: We aimed to compare post-vaccination response to BNT162b2 in kidney–pancreas transplant recipient, specifically in immunocompetent individuals, over two years of simultaneous monitoring. Methods: To determine the humoral response, the levels of the IgG and IgA anti-S1 antibodies were measured. To assess the cellular response to SARS-CoV-2, the released IFN-γ-S1 was determinate. Results and Conclusion: After primary vaccination, compared to immunocompetent subjects, SOTR showed lower seroconversion for both antibody classes. Only the additional dose produced antibodies at the level reached by the control group after the baseline vaccination. During the monitored period, SOTR did not achieve a positive cellular response in contrast to immunocompetent individuals, so in order to obtain longer protection, including immune memory, the adoption of booster doses of the vaccine should be considered.
Full article
(This article belongs to the Special Issue SARS-CoV-2 Infection and Vaccines for Patients with Renal Diseases)
►▼
Show Figures
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00844/article_deploy/html/images/vaccines-12-00844-g001-550.jpg?1721983837)
Figure 1
Open AccessArticle
Comparison of Post-Vaccination Cellular Immune Response in Patients with Common Variable Immune Deficiency
by
Aristitsa Mikhailovna Kostinova, Elena Alexandrovna Latysheva, Mikhail Petrovich Kostinov, Nelly Kimovna Akhmatova, Svetlana Anatolyevna Skhodova, Anna Egorovna Vlasenko, Alexander Petrovich Cherdantsev, Irina Leonidovna Solovеva, Isabella Abramovna Khrapunova, Marina Nikolaevna Loktionova, Ekaterina Alexandrovna Khromova and Arseniy Alexandrovich Poddubikov
Vaccines 2024, 12(8), 843; https://doi.org/10.3390/vaccines12080843 - 25 Jul 2024
Abstract
Background: The problem of identifying vaccine-specific T-cell responses is still a matter of debate. Currently, there are no universal, clearly defined, agreed upon criteria for assessing the effectiveness of vaccinations and their immunogenicity for the cellular component of immunity, even for healthy
[...] Read more.
Background: The problem of identifying vaccine-specific T-cell responses is still a matter of debate. Currently, there are no universal, clearly defined, agreed upon criteria for assessing the effectiveness of vaccinations and their immunogenicity for the cellular component of immunity, even for healthy people. But for patients with inborn errors of immunity (IEI), especially those with antibody deficiencies, evaluating cellular immunity holds significant importance. Aim: To examine the effect of one and two doses of inactivated adjuvanted subunit influenza vaccines on the expression of endosomal Toll-like receptors (TLRs) on the immune cells and the primary lymphocyte subpopulations in patients with common variable immunodeficiency (CVID). Materials and methods: During 2018–2019, six CVID patients received one dose of a quadrivalent adjuvanted influenza vaccine; in 2019–2020, nine patients were vaccinated with two doses of a trivalent inactivated influenza vaccine. The proportion of key lymphocyte subpopulations and expression levels of TLRs were analyzed using flow cytometry with monoclonal antibodies. Results: No statistically significant alterations in the absolute values of the main lymphocyte subpopulations were observed in CVID patients before or after vaccination with the different immunization protocols. However, after vaccination, a higher expression of TLR3 and TLR9 in granulocytes, monocytes, and lymphocytes was found in those patients who received two vaccine doses rather than one single dose. Conclusion: This study marks the first instance of using a simultaneous two-dose vaccination, which is associated with an elevated level of TLR expression in the immune cells. Administration of the adjuvanted vaccines in CVID patients appears promising. Further research into their impact on innate immunity and the development of more effective vaccination regimens is warranted.
Full article
Open AccessArticle
A Serological Survey of Measles and Rubella Antibodies among Different Age Groups in Eastern China
by
Rui Yan, Hanqing He, Xuan Deng, Yang Zhou, Xuewen Tang, Yao Zhu, Hui Liang, Yaping Chen, Mengya Yang, Yuxia Du, Can Chen, Jiaxin Chen, Shigui Yang and RIDPHE Group
Vaccines 2024, 12(8), 842; https://doi.org/10.3390/vaccines12080842 - 25 Jul 2024
Abstract
►▼
Show Figures
Background: Measles and rubella are vaccine-preventable diseases targeted for elimination in most World Health Organization regions, and China is considered to have momentum towards measles elimination. Therefore, this study aimed to assess the population immunity levels against measles and rubella in Zhejiang Province
[...] Read more.
Background: Measles and rubella are vaccine-preventable diseases targeted for elimination in most World Health Organization regions, and China is considered to have momentum towards measles elimination. Therefore, this study aimed to assess the population immunity levels against measles and rubella in Zhejiang Province in China in order to provide valuable insights for informing future public health measures and contributing to the ongoing global campaign against these diseases. Materials and methods: A cross-sectional serological survey was conducted in 2022. A total of 2740 blood samples were collected from healthy individuals spanning the age range of 0–59 years, representing diverse demographic strata across 11 prefectures in Zhejiang Province in China. The sera were tested for measles and rubella IgG antibodies to determine positivity rates and geometric mean concentrations (GMCs). Results: The overall positivity rate for the measles IgG antibody was 85.3%, with a GMC of 588.30 mIU/mL. The positivity rate for the rubella IgG antibody was 70.9%, and the GMC was 35.30 IU/mL. Measles IgG antibody positivity rates across the 0–11 months, 12–23 months, 24–35 months, 3–5 years, 6–9 years, 10–14 years, 15–19 years, 20–29 years, and 30–59 years age groups were 63.1%, 92.5%, 97.0%, 94.0%, 85.8%, 77.3%, 86.9%, 84.9%, and 88.7%, respectively (trend χ2 = 118.34, p < 0.001). Correspondingly, rubella antibody positivity rates for these same age brackets were 55.9%, 87.9%, 94.7%, 88.2%, 69.9%, 54.2%, 72.6%, 67.5%, and 74.3% (trend χ2 = 199.18, p < 0.001). Both univariate and multivariate analyses consistently demonstrated that age, immunization history, and differing economic levels were significant factors contributing to variations in antibody levels. Conclusions: The seroprevalence of measles and rubella was lower than that required for herd immunity. Periodic vaccination campaigns should be launched to increase immunity.
Full article
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00842/article_deploy/html/images/vaccines-12-00842-g001-550.jpg?1721986115)
Figure 1
Open AccessArticle
Assessment of Epidemiological Trend of Influenza-Like Illness in Italy from 2010/2011 to 2023/2024 Season: Key Points to Optimize Future Vaccination Strategies against Influenza
by
Sara Boccalini and Angela Bechini
Vaccines 2024, 12(8), 841; https://doi.org/10.3390/vaccines12080841 - 25 Jul 2024
Abstract
Seasonal influenza is an acute respiratory infectious disease due to influenza viruses, causing a relevant number of illnesses and deaths each year worldwide. Influenza is a preventable disease by vaccination. The aim of this study was to assess the epidemiology of seasonal influenza
[...] Read more.
Seasonal influenza is an acute respiratory infectious disease due to influenza viruses, causing a relevant number of illnesses and deaths each year worldwide. Influenza is a preventable disease by vaccination. The aim of this study was to assess the epidemiology of seasonal influenza in Italy through the analysis of data from the epidemiological and virological RespiVirNet surveillance system for the season 2010/2011 to 2023/2024 to identify the epidemiological key points to plan the most appropriate vaccination strategies. The cumulative and maximum weekly incidence of influenza-like illness (ILI) and epidemic period (beginning, end, duration in weeks) were assessed in the pre-pandemic period (2010/2011–2019/2020) and they were compared to the pandemic and post-pandemic one. In all seasons, children reported the highest incidence values of ILI and longer epidemic periods in contrast with the older population. The epidemic seasons 2020/2021 and 2021/2022 had abnormal trends while in the last seasons 2022/2023 and 2023/2024 the epidemiological and virological trends of ILI were confirmed as reported in the pre-pandemic period but with high intensity. Influenza virus A was predominant: the H3N2 subtype circulated more than virus H1N1pdm09. In the few seasons when influenza virus B was the most frequent influenza agent, it co-circulated with influenza virus A. The monitoring of cases is the fundamental tool to better understand the epidemiology of influenza and to optimize future preventive strategies.
Full article
(This article belongs to the Special Issue Vaccine Uptake in Italy, through the OBVIOUS Project and Other Independent Research)
►▼
Show Figures
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00841/article_deploy/html/images/vaccines-12-00841-g001-550.jpg?1721977957)
Figure 1
Open AccessArticle
Omicron XBB.1.16-Adapted Vaccine for COVID-19: Interim Immunogenicity and Safety Clinical Trial Results
by
María Jesús López Fernández, Silvia Narejos, Antoni Castro, José María Echave-Sustaeta, María José Forner, Eunate Arana-Arri, José Molto, Laia Bernad, Raúl Pérez-Caballero, Julia G. Prado, Dàlia Raïch-Regué, Rytis Boreika, Nuria Izquierdo-Useros, Benjamin Trinité, Julià Blanco, Joan Puig-Barberà and Silvina Natalini Martínez
Vaccines 2024, 12(8), 840; https://doi.org/10.3390/vaccines12080840 - 25 Jul 2024
Abstract
(1) Background: The global coronavirus disease 2019 vaccination adapts to protect populations from emerging variants. This communication presents interim findings from the new Omicron XBB.1.16-adapted PHH-1V81 protein-based vaccine compared to an XBB.1.5-adapted mRNA vaccine against various acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strains.
[...] Read more.
(1) Background: The global coronavirus disease 2019 vaccination adapts to protect populations from emerging variants. This communication presents interim findings from the new Omicron XBB.1.16-adapted PHH-1V81 protein-based vaccine compared to an XBB.1.5-adapted mRNA vaccine against various acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strains. (2) Methods: In a Phase IIb/III pivotal trial, adults previously vaccinated with a primary scheme and at least one booster dose of an EU-approved mRNA vaccine randomly received either the PHH-1V81 or BNT162b2 XBB.1.5 vaccine booster as a single dose. The primary efficacy endpoint assessed neutralization titers against the Omicron XBB.1.16 variant at day 14. Secondary endpoints evaluated neutralization titers and cellular immunity against different variants. Safety endpoints comprised solicited reactions up to day 7 post-vaccination and serious adverse events until the cut-off date of the interim analysis. Changes in humoral responses were assessed by pseudovirion-based or virus neutralization assays. (3) Results: At the cut-off date, immunogenicity assessments included 599 participants. Both boosters elicited neutralizing antibodies against XBB.1.16, XBB.1.5, and JN.1, with PHH-1V81 inducing a higher response for all variants. The PHH-1V8 booster triggers a superior neutralizing antibody response against XBB variants compared to the mRNA vaccine. A subgroup analysis consistently revealed higher neutralizing antibody responses with PHH-1V81 across age groups, SARS-CoV-2 infection history, and the number of prior vaccination shots. A safety analysis (n = 607) at the day 14 visit revealed favorable safety profiles without any serious vaccine-related adverse events. (4) Conclusions: PHH-1V81 demonstrates superiority on humoral immunogenicity compared to the mRNA vaccine against XBB variants and non-inferiority against JN.1 with a favorable safety profile and lower reactogenicity, confirming its potential as a vaccine candidate.
Full article
(This article belongs to the Special Issue SARS-CoV-2 Variants, Vaccines, and Immune Responses)
►▼
Show Figures
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00840/article_deploy/html/images/vaccines-12-00840-g001-550.jpg?1721976967)
Figure 1
Open AccessArticle
Exploring the Inherent Heterogeneity of Vaccine Hesitancy: A Study of a Childhood-Vaccine-Hesitant Population
by
Monika Lamot, Andrej Kirbiš and Mitja Vrdelja
Vaccines 2024, 12(8), 839; https://doi.org/10.3390/vaccines12080839 - 25 Jul 2024
Abstract
Vaccine hesitancy and its determinants have been previously widely researched. Vaccine hesitancy has been defined as a continuum of attitudes, ranging from accepting vaccines with doubts to rejecting them. The present study aims to explore the heterogeneity of a childhood-vaccine-hesitant group by using
[...] Read more.
Vaccine hesitancy and its determinants have been previously widely researched. Vaccine hesitancy has been defined as a continuum of attitudes, ranging from accepting vaccines with doubts to rejecting them. The present study aims to explore the heterogeneity of a childhood-vaccine-hesitant group by using a person-oriented approach–latent profile analysis. A non-representative cross-sectional sample of vaccine-hesitant Slovenians (N = 421, Mage = 35.21, 82.9% women) was used to identify differences based on their reliance on personal research (“self” researching instead of relying on science), overconfidence in knowledge, endorsement of conspiracy theories, complementary and alternative medicine, and trust in the healthcare system. The analysis revealed three profiles of vaccine-hesitant individuals. The most hesitant profile—vaccine rejecting—expressed the greatest reliance on personal research, expressed the highest endorsement of conspiracy theories and complementary and alternative medicine, showed moderate overconfidence in their knowledge, and expressed the highest levels of distrust in the healthcare system. We further found differences in sociodemographic structure and that the identified profiles differed in their attitudes regarding MMR, HPV, and Seasonal Influenza vaccinations. The present study demonstrates the heterogeneity of the vaccine-hesitant community and offers insights into some of the traits, which are crucial for designing pro-vaccine campaigns.
Full article
(This article belongs to the Special Issue Vaccine Literacy and Social–Cognitive Determinants of Vaccination)
►▼
Show Figures
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00839/article_deploy/html/images/vaccines-12-00839-g001-550.jpg?1721986999)
Figure 1
Open AccessArticle
Safety and Immunogenicity of the Nonavalent Human Papillomavirus Vaccine in Women Living with HIV
by
Carmen Hidalgo-Tenorio, Raquel Moya, Mohamed Omar, Leopoldo Muñoz, Antonio SamPedro, Jabier López-Hidalgo, Coral Garcia-Vallecillos and Patricia Gómez-Ronquillo
Vaccines 2024, 12(8), 838; https://doi.org/10.3390/vaccines12080838 - 25 Jul 2024
Abstract
Background: The objectives were to evaluate the safety and immunogenicity of the nonavalent human papillomavirus (nHPV) vaccine in adult Spanish women living with HIV (WLHIV); the prevalence of anal and cervical dysplasia and nHPV vaccine genotypes in the anus and cervix; and risk
[...] Read more.
Background: The objectives were to evaluate the safety and immunogenicity of the nonavalent human papillomavirus (nHPV) vaccine in adult Spanish women living with HIV (WLHIV); the prevalence of anal and cervical dysplasia and nHPV vaccine genotypes in the anus and cervix; and risk factors for high-risk HPV (HR-HPV) infection in anal mucosa. Methods: In this single-center, open-arm, non-randomized clinical trial, the nHPV vaccine was administered at 0, 2, and 6 months to WLHIV enrolled between February 2020 and November 2023, measuring vaccine antibody titers pre-vaccination and at 2, 6, and 7 months after the first dose. Cervical and anal cytology and HPV PCR genotyping studies were performed. Women with abnormal cytology and/or anal or cervical HPV infection at baseline underwent high-resolution anoscopy and/or colposcopy. Results: A total of 122 participants were included with mean age of 49.6 years: 52.5% smoked; 10.7% had anal-genital condylomatosis; 38.5% were infected by HR-HPV in the anus and 25.4% in the cervix, most frequently HPV 16; 19.1% had anal intraepithelial neoplasia 1-(AIN1); and 3.1% had cervical intraepithelial neoplasia 1 and 2 (CIN1/CIN2). Vaccine administration did not modify viral–immunological status (CD4 [809 ± 226.8 cells/uL vs. 792.35 ± 349.95; p = 0.357]) or plasma HIV load (3.38 ± 4.41 vs. 1.62 ± 2.55 cop/uL [log]; p = 0.125). Anti-HPV antibodies ([IQR: 0–0] vs. 7.63 nm [IQR: 3.46–19.7]; p = 0.0001) and seroconversion rate (8.2% vs. 96.7% [p = 0.0001]) were increased at 7 versus 0 months. There were no severe vaccine-related adverse reactions; injection-site pain was reported by around half of the participants. HR-HPV infection in the anus was solely associated with a concomitant cervix infection (HR 5.027; 95% CI: 1.009–25.042). Conclusions: nHPV vaccine in adult WLHIV is immunogenic and safe.
Full article
(This article belongs to the Special Issue Advances in Vaccines against Infectious Diseases)
►▼
Show Figures
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00838/article_deploy/html/images/vaccines-12-00838-g001-550.jpg?1721903445)
Figure 1
Open AccessArticle
UL56 Is Essential for Herpes Simplex Virus-1 Virulence In Vivo but Is Dispensable for Induction of Host-Protective Immunity
by
Nopprarat Tongmuang, Meera Krishnan, Viv Connor, Colin Crump and Liselotte E. Jensen
Vaccines 2024, 12(8), 837; https://doi.org/10.3390/vaccines12080837 - 25 Jul 2024
Abstract
Herpes simplex virus-1 (HSV-1) is common and can cause significant disease in humans. Unfortunately, efforts to develop effective vaccines against HSV-1 have so far failed. A detailed understanding of how the virus infects its host and how the host mounts potent immune responses
[...] Read more.
Herpes simplex virus-1 (HSV-1) is common and can cause significant disease in humans. Unfortunately, efforts to develop effective vaccines against HSV-1 have so far failed. A detailed understanding of how the virus infects its host and how the host mounts potent immune responses against the virus may inform new vaccine approaches. Here, using a zosteriform mouse model, we examined how the HSV-1 gene UL56 affects the ability of the virus to cause morbidity and generate protective immunity. A UL56 deletion mutant, ΔUL56, was derived from the wild-type HSV-1 strain SC16, alongside a revertant strain in which UL56 was reintroduced in ΔUL56. In vitro, the three virus strains replicated in a similar manner; however, in vivo, only the wild type and the revertant strains caused shingles-like skin lesions and death. Mice previously infected with ΔUL56 became resistant to a lethal challenge with the wild-type SC16. The protective immunity induced by ΔUL56 was independent of IL-1, IL-33, and IL-36 signaling through IL-1RAP. Both skin and intramuscular ΔUL56 inoculation generated protective immunity against a lethal SC16 challenge. After 6 months, female mice remained resistant to infection, while male mice exhibited signs of declining protection. Our data demonstrate that UL56 is important for the ability of HSV-1 to spread within the infected host and that a ∆UL56 strain elicits an effective immune response against HSV-1 despite this loss of virulence. These findings may guide further HSV-1 vaccine development.
Full article
(This article belongs to the Special Issue Vaccines and Therapeutic Approaches in Dermatological Diseases)
►▼
Show Figures
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00837/article_deploy/html/images/vaccines-12-00837-g001-550.jpg?1721967989)
Figure 1
Open AccessReview
Tumor Neoepitope-Based Vaccines: A Scoping Review on Current Predictive Computational Strategies
by
Luiz Gustavo do Nascimento Rocha, Paul Anderson Souza Guimarães, Maria Gabriela Reis Carvalho and Jeronimo Conceição Ruiz
Vaccines 2024, 12(8), 836; https://doi.org/10.3390/vaccines12080836 - 24 Jul 2024
Abstract
Therapeutic cancer vaccines have been considered in recent decades as important immunotherapeutic strategies capable of leading to tumor regression. In the development of these vaccines, the identification of neoepitopes plays a critical role, and different computational methods have been proposed and employed to
[...] Read more.
Therapeutic cancer vaccines have been considered in recent decades as important immunotherapeutic strategies capable of leading to tumor regression. In the development of these vaccines, the identification of neoepitopes plays a critical role, and different computational methods have been proposed and employed to direct and accelerate this process. In this context, this review identified and systematically analyzed the most recent studies published in the literature on the computational prediction of epitopes for the development of therapeutic vaccines, outlining critical steps, along with the associated program’s strengths and limitations. A scoping review was conducted following the PRISMA extension (PRISMA-ScR). Searches were performed in databases (Scopus, PubMed, Web of Science, Science Direct) using the keywords: neoepitope, epitope, vaccine, prediction, algorithm, cancer, and tumor. Forty-nine articles published from 2012 to 2024 were synthesized and analyzed. Most of the identified studies focus on the prediction of epitopes with an affinity for MHC I molecules in solid tumors, such as lung carcinoma. Predicting epitopes with class II MHC affinity has been relatively underexplored. Besides neoepitope prediction from high-throughput sequencing data, additional steps were identified, such as the prioritization of neoepitopes and validation. Mutect2 is the most used tool for variant calling, while NetMHCpan is favored for neoepitope prediction. Artificial/convolutional neural networks are the preferred methods for neoepitope prediction. For prioritizing immunogenic epitopes, the random forest algorithm is the most used for classification. The performance values related to the computational models for the prediction and prioritization of neoepitopes are high; however, a large part of the studies still use microbiome databases for training. The in vitro/in vivo validations of the predicted neoepitopes were verified in 55% of the analyzed studies. Clinical trials that led to successful tumor remission were identified, highlighting that this immunotherapeutic approach can benefit these patients. Integrating high-throughput sequencing, sophisticated bioinformatics tools, and rigorous validation methods through in vitro/in vivo assays as well as clinical trials, the tumor neoepitope-based vaccine approach holds promise for developing personalized therapeutic vaccines that target specific tumor cancers.
Full article
(This article belongs to the Special Issue Tumor Vaccines: Current Processes, Prevailing Challenges and Future Perspectives)
►▼
Show Figures
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00836/article_deploy/html/images/vaccines-12-00836-g001-550.jpg?1721830180)
Figure 1
Open AccessArticle
Public Knowledge and Beliefs Regarding Pharmacy-Based Immunization in Poland—A Nationwide Cross-Sectional Study, 2024
by
Iwona Wrześniewska-Wal, Justyna Grudziąż-Sękowska, Jarosław Pinkas and Mateusz Jankowski
Vaccines 2024, 12(8), 835; https://doi.org/10.3390/vaccines12080835 - 24 Jul 2024
Abstract
Pharmacy vaccinations are a key public health intervention. This study aimed to assess society’s knowledge about pharmacy vaccinations in Poland. A cross-sectional study was conducted from 10 to 13 May 2024 among 1126 adults; the survey questionnaire contained 13 closed questions. Men (OR:
[...] Read more.
Pharmacy vaccinations are a key public health intervention. This study aimed to assess society’s knowledge about pharmacy vaccinations in Poland. A cross-sectional study was conducted from 10 to 13 May 2024 among 1126 adults; the survey questionnaire contained 13 closed questions. Men (OR: 1.32; [1.02–1.70]; p < 0.05), and people aged 50–64 (OR: 1.55; [1.05–2.28]; p < 0.05), people with higher education (OR:1.74; [1.35–2.26]; p < 0.001), and people declaring trust in the pharmacist’s competencies (OR:3.95; [3.03–5.15]; p < 0.001) more often declared knowledge of vaccinations in pharmacies. Support for these services was declared by men (OR:1.74; [1.28–2.36]; p < 0.001) and people with higher education (OR:1.39; [1.02–1.89]; p < 0.05) and participants declaring trust in the pharmacist’s competences (OR:20.30; [14.65–28.11]; p < 0.001). Trust in pharmacists was important. People declaring trust in pharmacists were much more willing to get vaccinated against influenza (40.2%) and zoster (38.0%) at a pharmacy and declared that they would vaccinate their children against HPV at a pharmacy (38.8%) compared to people who did not trust the competences of pharmacists (p < 0.001). There was a significant difference in the case of influenza. People who trusted pharmacists were five times more likely to declare their willingness to get vaccinated against influenza (p < 0.001).
Full article
(This article belongs to the Special Issue The Current Situation and Future Perspectives of Vaccines against Infectious Diseases in Children and Women—2nd Edition)
Open AccessArticle
The Immunomodulatory Function of Assembled Composite Nanopolypeptide Containing Bursal-Derived BP7 (CNPB7) in Promoting the Mucosal Immune Response within Poultry Immunization
by
Xinyu Guo, Jianing Hu, Guihu Yin, Yiqin Cai, Zichen Gao, Ye Liu, Meng Zhong, Ruiying Wang and Xiuli Feng
Vaccines 2024, 12(8), 834; https://doi.org/10.3390/vaccines12080834 - 24 Jul 2024
Abstract
Mucosal immunity is the main defense line against respiratory disease pathogens. Newcastle disease and avian infectious bronchitis are common respiratory diseases in poultry. However, the mucosal immune response is not sufficiently activated and thus fails to achieve the ideal immune protection. Therefore, it
[...] Read more.
Mucosal immunity is the main defense line against respiratory disease pathogens. Newcastle disease and avian infectious bronchitis are common respiratory diseases in poultry. However, the mucosal immune response is not sufficiently activated and thus fails to achieve the ideal immune protection. Therefore, it is important to develop a suitable mucosal immune adjuvant to enhance the immune response of live vaccines. Here, the bursal-derived peptide BP7, β-glucan, and hyaluronic acid were selected as the adjuvant to be assembled into the composite nanopolypeptide adjuvant (CNPB7) with ultrasonic dispersion technology. The results showed that after optimizing assembly conditions, the optimal average particle size of nanoparticle CNPB7 was 514.9 nm and PDI was 0.298. To evaluate the non-specific immune responses of nanoparticle CNPB7, the chickens were immunized only with nanoparticle CNPB7. It was confirmed that nanoparticle CNPB7 enhanced the expression of CD3, CD4, CD80, and CD86 factors in the spleen lymphocyte from the chicken immunized with nanoparticle CNPB7. To investigate the mucosal immune response of nanoparticle CNPB7, the chickens were orally immunized with Newcastle disease virus (NDV)–infectious bronchitis virus (IBV) dual vaccines and CNPB7. The results proved that the levels of immunoglobulin SIgA, IL-4, IFN-γ, and IL-13 in the mucus samples from the respiratory and digestive tract in chicken immunized with nanoparticle CNPB7 and vaccines were significantly increased, compared to that of vaccine control. Finally, it was observed that nanoparticle CNPB7 promoted specific increased antibody productions against NDV and IBV in the immunized chicken. These results proved that the assembled nanoparticle CNPB7 could enhance the vaccination efficacy in chicken, which provided the experimental basis for the development of new adjuvants, and offered technical support for preventing virus transmission of avian diseases.
Full article
(This article belongs to the Special Issue Animal Vaccines)
►▼
Show Figures
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00834/article_deploy/html/images/vaccines-12-00834-g001-550.jpg?1721815201)
Figure 1
Open AccessArticle
PREVAX: A Phase I Clinical Trial of an EGF-Based Vaccine in Moderate-to-Severe COPD Patients
by
Jenysbel de la C. Hernandez Reyes, Orestes Santos Morales, Laura Hernandez Moreno, Pedro Pablo Pino Alfonso, Elia Neninger Vinageras, Julia Lilliam Knigths Montalvo, Aliuska Aguilar Sosa, Amnely Gonzalez Morera, Patricia Lorenzo-Luaces Alvárez, Yadira Aguilar Venegas, Mayelin Troche Concepción, Loipa Medel Pérez, Yanela Santiesteban González, Lázara García Fernández, Lorena Regueiro Rodríguez, Amparo Macías Abrahan, Mayrel Labrada Mon, Kalet León Monzón, Danay Saavedra Hernández and Tania Crombet Ramos
Vaccines 2024, 12(8), 833; https://doi.org/10.3390/vaccines12080833 - 24 Jul 2024
Abstract
Background: EGFR has been suggested to contribute to COPD development and progression. Excessive ligand activation of the receptor leads to epithelial hyperproliferation and increased production of mucus, together with alterations in the primary cilia. The present study was designed to evaluate the safety
[...] Read more.
Background: EGFR has been suggested to contribute to COPD development and progression. Excessive ligand activation of the receptor leads to epithelial hyperproliferation and increased production of mucus, together with alterations in the primary cilia. The present study was designed to evaluate the safety and effect of depleting EGF in moderate-to-severe COPD patients, with an EGF-based vaccine. Patients and methods: A phase I trial was conducted in subjects with moderate or severe COPD. The anti-EGF vaccine schedule consisted of 4 biweekly doses followed by 4 monthly boosters. The primary endpoint was the evaluation of the safety and immunogenicity of the vaccine, together with the change in FEV1 and physical function at week 24. Results: Twenty-six patients with moderate or severe COPD were included in the trial. The vaccine was well tolerated and no serious related adverse events were reported. Ninety percent of the individuals developed a protective antibody response. The specific anti-EGF antibodies had high avidity and were able to inhibit EGFR phosphorylation. At the end of vaccination, serum EGF became undetectable. At week 24, there was a clinically significant improvement in lung function, with a mean change in trough FEV1 of 106 mL. Patients also increased their physical functioning. Conclusions: The EGF-based vaccine was immunogenic and provoked an EGF exhaustion in patients with moderate-to-severe COPD. Depleting EGF might result in a meaningful increase in FEV1, with good tolerability. The current results provide new avenues to treat chronic inflammatory lung diseases associated with EGFR aberrant signaling.
Full article
(This article belongs to the Section Therapeutic Vaccines and Antibody Therapeutics)
►▼
Show Figures
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00833/article_deploy/html/images/vaccines-12-00833-g001-550.jpg?1721789424)
Figure 1
Open AccessArticle
FlagT4G Vaccine Prevents Transplacental Transmission of Highly Virulent Classical Swine Fever Virus after Single Vaccination in Pregnant Sows
by
Liani Coronado, Adriana Muñoz-Aguilera, Guillermo Cantero, Patricia Martínez, Mònica Alberch, Rosa Rosell, Douglas P. Gladue, Manuel V. Borca and Llilianne Ganges
Vaccines 2024, 12(8), 832; https://doi.org/10.3390/vaccines12080832 - 23 Jul 2024
Abstract
The transplacental transmission of CSFV and the resulting persistent congenital infection in newborn piglets have been abundantly discussed in pregnant sows suffering from virus infection. Importantly, the availability of safe commercial vaccines with proven efficacy to prevent the generation of congenital and postnatal
[...] Read more.
The transplacental transmission of CSFV and the resulting persistent congenital infection in newborn piglets have been abundantly discussed in pregnant sows suffering from virus infection. Importantly, the availability of safe commercial vaccines with proven efficacy to prevent the generation of congenital and postnatal persistent infections in pregnant sows are critical tools for controlling the disease in CSF endemic areas. Here, we demonstrate the high efficacy of a single dose of the recombinant FlagT4G vaccine to provide solid protection in pregnant sows against transplacental transmission of a highly virulent CSFV. Pregnant sows vaccinated with FlagT4G at 44 days of gestation elicited a strong CSFV-specific antibody response, with neutralizing antibody levels above those required for protection against CSFV. Importantly, after the challenge with a highly virulent CSFV, all foetuses from FlagT4G-vaccinated sows lacked CSF macroscopic lesions and showed a complete absence of the challenge virus in their internal organs at day 79 of gestation. Therefore, pregnant sows safely vaccinated with FlagT4G without affecting reproductive efficacy are efficaciously protected, along with their foetuses, against the infection and disease caused by a CSFV virulent field strain.
Full article
(This article belongs to the Section Veterinary Vaccines)
►▼
Show Figures
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00832/article_deploy/html/images/vaccines-12-00832-g001-550.jpg?1721813777)
Figure 1
Open AccessArticle
Green Routes: Exploring Protein-Based Virus-like Nanoparticle Transport and Immune Activation in Nicotiana benthamiana for Biotechnological Applications
by
Romano Josi, Alessandro Pardini, Alexander Haindrich, Sanjana V. Marar, Anne-Cathrine S. Vogt, Arthur Gessler, Doris Rentsch, Paolo Cherubini, Martin F. Bachmann and Mona O. Mohsen
Vaccines 2024, 12(8), 831; https://doi.org/10.3390/vaccines12080831 - 23 Jul 2024
Abstract
►▼
Show Figures
Viral, bacterial, fungal, and nematode infections cause significant agricultural losses, with limited treatment options, necessitating novel approaches to enhance plant defense systems and protection against pathogens. Virus-like nanoparticles (VLPs), extensively used in animal and human therapies (e.g., vaccines and immune enhancers), hold potential
[...] Read more.
Viral, bacterial, fungal, and nematode infections cause significant agricultural losses, with limited treatment options, necessitating novel approaches to enhance plant defense systems and protection against pathogens. Virus-like nanoparticles (VLPs), extensively used in animal and human therapies (e.g., vaccines and immune enhancers), hold potential for novel agricultural solutions and advancing plant nanotechnology. This study employed various methodologies, including VLP production, confocal microscopy, and real-time qPCR. Our findings demonstrated the presence of 30 nm Qβ-VLPs, fluorescently labeled, within the intercellular space of Nicotiana benthamiana leaves one hour post-infiltration. Furthermore, infiltration with Qβ-VLPs led to an upregulation of key defense genes (NbPR1a, NbPR5, NbNPR, NbERF1, NbMYC2, and NbLRR2) in treated plants. Using RT-qPCR, a significant increase in the relative expression levels of defense genes was observed, with sustained high levels of NbERF1 and NbLRR2 even after 24 h. These findings suggest that Qβ-VLPs effectively upregulate genes crucial for pathogen defense in N. benthamiana, initiating PAMP-triggered immunity and launching signaling cascades that enhance defense mechanisms. This innovative application of VLPs to activate plant defense programs advances plant nanobiotechnology, offering new agricultural solutions.
Full article
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00831/article_deploy/html/images/vaccines-12-00831-g001-550.jpg?1721739211)
Figure 1
Open AccessArticle
Formulation Development of a COVID-19 Recombinant Spike Protein-Based Vaccine
by
Emily Xiao, Clémentine Mirabel, Didier Clénet, Shaolong Zhu, Andrew James, Luciano Ettorre, Trevor Williams, Jason Szeto, Nausheen Rahman and Salvador Fernando Ausar
Vaccines 2024, 12(8), 830; https://doi.org/10.3390/vaccines12080830 - 23 Jul 2024
Abstract
The purpose of this study was to develop a formulation for a recombinant prefusion spike protein vaccine against SARS-CoV-2. It was found that the spike protein was susceptible to aggregation due to mechanical stress. Therefore, formulation studies were initiated focused on screening pharmaceutical
[...] Read more.
The purpose of this study was to develop a formulation for a recombinant prefusion spike protein vaccine against SARS-CoV-2. It was found that the spike protein was susceptible to aggregation due to mechanical stress. Therefore, formulation studies were initiated focused on screening pharmaceutical excipients capable of preventing this. The screening of a panel of potential stabilizing conditions found that Tween 20 could inhibit mechanically induced aggregation. A concentration-dependent study indicated that a higher concentration of Tween 20 (0.2% v/v) was required to prevent conformational changes in the trimer. The conformational changes induced by mechanical stress were characterized by size exclusion chromatography (SEC) and hydrogen–deuterium exchange mass spectrometry (HDX-MS), indicating the formation of an extended trimeric conformation that was also unable to bind to antibodies directed to the S2 domain. Long-term stability modeling, using advanced kinetic analysis, indicated that the formulation containing 0.2% (v/v) Tween 20 at a neutral pH was predicted to be stable for at least two years at 2 °C to 8 °C. Additional stabilizer screening conducted by thermal shift assay indicated that sucrose and glycerol were able to significantly increase the spike protein melting temperature (Tm) and improve the overall thermostability of the spike protein in a short-term stability study. Thus, while 0.2% (v/v) Tween 20 was sufficient to prevent aggregation and to maintain spike protein stability under refrigeration, the addition of sucrose further improved vaccine thermostability. Altogether, our study provides a systematic approach to the formulation of protein-based COVID-19 vaccine and highlights the impact of mechanical stress on the conformation of the spike protein and the significance of surfactants and stabilizers in maintaining the structural and functional integrity of the spike protein.
Full article
(This article belongs to the Section COVID-19 Vaccines and Vaccination)
►▼
Show Figures
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00830/article_deploy/html/images/vaccines-12-00830-g001-550.jpg?1721817236)
Figure 1
Open AccessArticle
Gold Nanoparticle Virus-like Particles Presenting SARS-CoV-2 Spike Protein: Synthesis, Biophysical Properties and Immunogenicity in BALB/c Mice
by
Vivian A. Salazar, Joan Comenge, Rosa Suárez-López, Judith A. Burger, Rogier W. Sanders, Neus G. Bastús, Carlos Jaime, Joan Joseph-Munne and Victor Puntes
Vaccines 2024, 12(8), 829; https://doi.org/10.3390/vaccines12080829 - 23 Jul 2024
Abstract
Gold nanoparticles (AuNPs) decorated with antigens have recently emerged as promising tools for vaccine development due to their innate ability to provide stability to antigens and modulate immune responses. In this study, we have engineered deactivated virus-like particles (VLPs) by precisely functionalizing gold
[...] Read more.
Gold nanoparticles (AuNPs) decorated with antigens have recently emerged as promising tools for vaccine development due to their innate ability to provide stability to antigens and modulate immune responses. In this study, we have engineered deactivated virus-like particles (VLPs) by precisely functionalizing gold cores with coronas comprising the full SARS-CoV-2 spike protein (S). Using BALB/c mice as a model, we investigated the immunogenicity of these S-AuNPs-VLPs. Our results demonstrate that S-AuNPs-VLPs consistently enhanced antigen-specific antibody responses compared to the S protein free in solution. This enhancement included higher binding antibody titers, higher neutralizing capacity of antibodies, and stronger T-cell responses. Compared to the mRNA COVID-19 vaccine, where the S protein is synthesized in situ, S-AuNPs-VLPs induced comparable binding and neutralizing antibody responses, but substantially superior T-cell responses. In conclusion, our study highlights the potential of conjugated AuNPs as an effective antigen-delivery system for protein-based vaccines targeting a broad spectrum of infectious diseases and other emergent viruses.
Full article
(This article belongs to the Special Issue Virus-Like Particle Vaccine Development)
►▼
Show Figures
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00829/article_deploy/html/images/vaccines-12-00829-g001-550.jpg?1721726324)
Figure 1
Open AccessArticle
Immunogenicity of an Extended Dose Interval for the Ad26.ZEBOV, MVA-BN-Filo Ebola Vaccine Regimen in Adults and Children in the Democratic Republic of the Congo
by
Edward Man-Lik Choi, Kambale Kasonia, Hugo Kavunga-Membo, Daniel Mukadi-Bamuleka, Aboubacar Soumah, Zephyrin Mossoko, Tansy Edwards, Darius Tetsa-Tata, Rockyath Makarimi, Oumar Toure, Grace Mambula, Hannah Brindle, Anton Camacho, Nicholas E. Connor, Pierre Mukadi, Chelsea McLean, Babajide Keshinro, Auguste Gaddah, Cynthia Robinson, Kerstin Luhn, Julie Foster, Chrissy h. Roberts, John Emery Johnson, Nathalie Imbault, Daniel G. Bausch, Rebecca F. Grais, Deborah Watson-Jones and Jean Jacques Muyembe-Tamfumadd
Show full author list
remove
Hide full author list
Vaccines 2024, 12(8), 828; https://doi.org/10.3390/vaccines12080828 - 23 Jul 2024
Abstract
During the 2018–2020 Ebola virus disease outbreak in Democratic Republic of the Congo, a phase 3 trial of the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine (DRC-EB-001) commenced in Goma, with participants being offered the two-dose regimen given 56 days apart. Suspension of trial activities in
[...] Read more.
During the 2018–2020 Ebola virus disease outbreak in Democratic Republic of the Congo, a phase 3 trial of the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine (DRC-EB-001) commenced in Goma, with participants being offered the two-dose regimen given 56 days apart. Suspension of trial activities in 2020 due to the COVID-19 pandemic led to some participants receiving a late dose 2 outside the planned interval. Blood samples were collected from adults, adolescents, and children prior to their delayed dose 2 vaccination and 21 days after, and tested for IgG binding antibodies against Ebola virus glycoprotein using the Filovirus Animal Nonclinical Group (FANG) ELISA. Results from 133 participants showed a median two-dose interval of 9.3 months. The pre-dose 2 antibody geometric mean concentration (GMC) was 217 ELISA Units (EU)/mL (95% CI 157; 301) in adults, 378 EU/mL (281; 510) in adolescents, and 558 EU/mL (471; 661) in children. At 21 days post-dose 2, the GMC increased to 22,194 EU/mL (16,726; 29,449) in adults, 37,896 EU/mL (29,985; 47,893) in adolescents, and 34,652 EU/mL (27,906; 43,028) in children. Participants receiving a delayed dose 2 had a higher GMC at 21 days post-dose 2 than those who received a standard 56-day regimen in other African trials, but similar to those who received the regimen with an extended interval.
Full article
(This article belongs to the Special Issue Recent Scientific Advances in Vaccination against Ebola and Marburg Virus Diseases)
►▼
Show Figures
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00828/article_deploy/html/images/vaccines-12-00828-g001-550.jpg?1721728874)
Figure 1
Open AccessArticle
Preliminary Evaluation of the Safety and Immunogenicity of a Novel Protein-Based Pneumococcal Vaccine in Healthy Adults Aged 18–49: A Phase Ia Randomized, Double Blind, Placebo-Controlled Clinical Study
by
Yanxia Wang, Gang Shi, Xue Wang, Zhiqiang Xie, Jinbo Gou, Lili Huang, Haitao Huang, Wangyang You, Ruijie Wang, Yongli Yang, Feiyu Wang, Tao Zhu and Dongyang Zhao
Vaccines 2024, 12(8), 827; https://doi.org/10.3390/vaccines12080827 - 23 Jul 2024
Abstract
►▼
Show Figures
Background: Protein-based pneumococcal vaccines (PBPVs) may offer expanded protection against Streptococcus pneumoniae and tackle the antimicrobial resistance crisis in pneumococcal infections. This study examined the safety and immunogenicity in healthy adults vaccinated with three doses of a protein-based pneumococcal vaccine containing pneumococcal
[...] Read more.
Background: Protein-based pneumococcal vaccines (PBPVs) may offer expanded protection against Streptococcus pneumoniae and tackle the antimicrobial resistance crisis in pneumococcal infections. This study examined the safety and immunogenicity in healthy adults vaccinated with three doses of a protein-based pneumococcal vaccine containing pneumococcal surface protein A (PspA) (PRX1, P3296 and P5668) and in combination with a recombinant detoxified pneumolysin protein (PlyLD). Methods: This phase Ia randomized, double blind, placebo-controlled clinical study enrolled healthy adults aged 18–49 years. The participants were randomized into experimental (low-dose, medium-dose, high-dose) and placebo groups in a ratio of 3:1. Three doses of investigational vaccine were given to the participants with an interval of two months. Safety endpoints included the occurrence of total adverse reactions, solicited local and systemic adverse reactions, unsolicited adverse reactions, serious adverse events (SAEs), and several laboratory parameters. Immunogenicity endpoints included geometric mean titers (GMT) of anti-PspA (PRX1, P3296 and P5668) and anti-PlyLD antibodies level as determined by ELISA, seropositivity rates of PspA and PlyLD antibodies (>4-fold increase) and neutralization activity of anti-Ply antibody in serum. Results: A total of 118 participants completed the study of three doses. The candidate PBPV was safe and well-tolerated in all experimental groups. No vaccine-related SAEs were observed in this study. Most solicited adverse reactions were mild and transient. The most frequently reported solicited adverse reactions in the medium- and high-dose groups was pain at the injection site, while in the low-dose group it was elevated blood pressure. The immunogenicity data showed a sharp increase in the GMT level of anti-PspA-RX1, anti-PspA-3296, anti-PspA-5668, and anti-PlyLD antibodies in serum. The results also showed that the elicited antibodies were dosage-dependent. The high-dose group showed a higher immune response against PspA-RX1, PspA-3296, PspA-5668, and PlyLD antigens. However, repeat vaccination did not increase the level of anti-PspA antibodies but the level of anti-PlyLD antibody. High seropositivity rates were also observed for anti-PspA-RX1, anti-PspA-3296, anti-PspA-5668, and anti-PlyLD antibodies. In addition, a significant difference in the GMT levels of anti-Ply antibody between the high-, medium-, and low-dose groups post each vaccination were indicated by neutralization activity tests. Conclusions: The PBPV showed a safe and immunogenic profile in this clinical trial. Taking into consideration both safety and immunogenicity data, we propose a single dose of 50 µg (medium dose) of PBPV as the optimum approach in providing expanded protection against Streptococcus pneumoniae.
Full article
![](https://pub.mdpi-res.com/vaccines/vaccines-12-00827/article_deploy/html/images/vaccines-12-00827-g001-550.jpg?1721718566)
Figure 1
![Vaccines vaccines-logo](https://pub.mdpi-res.com/img/journals/vaccines-logo.png?8600e93ff98dbf14)
Journal Menu
► ▼ Journal Menu-
- Vaccines Home
- Aims & Scope
- Editorial Board
- Reviewer Board
- Topical Advisory Panel
- Instructions for Authors
- Special Issues
- Topics
- Sections & Collections
- Article Processing Charge
- Indexing & Archiving
- Editor’s Choice Articles
- Most Cited & Viewed
- Journal Statistics
- Journal History
- Journal Awards
- Society Collaborations
- Conferences
- Editorial Office
Journal Browser
► ▼ Journal BrowserHighly Accessed Articles
Latest Books
E-Mail Alert
News
Topics
Topic in
Cells, Diseases, Healthcare, IJMS, Vaccines
Inflammation: The Cause of all Diseases 2.0
Topic Editors: Vasso Apostolopoulos, Jack Feehan, Vivek P. ChavdaDeadline: 31 July 2024
Topic in
Biomedicines, JCM, Pathogens, Vaccines, Viruses
Discovery and Development of Monkeypox Disease Treatments
Topic Editors: Mohd Imran, Ali A. RabaanDeadline: 31 August 2024
Topic in
Brain Sciences, Clinics and Practice, COVID, Life, Vaccines, Viruses
Multifaceted Efforts from Basic Research to Clinical Practice in Controlling COVID-19 Disease
Topic Editors: Yih-Horng Shiao, Rashi OjhaDeadline: 30 September 2024
Topic in
Cancers, Current Oncology, Diseases, JCM, Vaccines
Gut Microbiota and Cancer
Topic Editors: Dong Tang, Takeo FukagawaDeadline: 25 November 2024
![loading...](https://pub.mdpi-res.com/img/loading_circle.gif?9a82694213036313?1721979229)
Conferences
Special Issues
Special Issue in
Vaccines
COVID-19 Disparities and Vaccine Equity
Guest Editors: Alika K. Maunakea, Ruben Juarez, May OkihiroDeadline: 31 July 2024
Special Issue in
Vaccines
Estimating Vaccines' Value and Impact
Guest Editor: Philipp LambachDeadline: 15 August 2024
Special Issue in
Vaccines
Animal Vaccines
Guest Editors: Hsian-Yu Wang, David BenfieldDeadline: 31 August 2024
Special Issue in
Vaccines
Recent Discoveries and Developments in RNA and DNA Vaccines
Guest Editor: Hang Fai (Henry) KwokDeadline: 8 September 2024
Topical Collections
Topical Collection in
Vaccines
COVID-19 Vaccine Hesitancy: Correlates and Interventions
Collection Editors: Manoj Sharma, Kavita Batra
Topical Collection in
Vaccines
Topic Advisory Panel Members’ Collection Series: Immunization and Vaccines for Infectious Diseases
Collection Editors: Shumaila Hanif, Ravinder Kumar
Topical Collection in
Vaccines
Research on Monoclonal Antibodies and Antibody Engineering
Collection Editor: Tatsuya Yamazaki