Vaccines

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19 pages, 2851 KB

Open AccessArticle

Adenovector 26 Encoded RSV Prefusion F Protein (Ad26.RSV.preF) Does Not Predispose to Enhanced Respiratory Disease in Preclinical Rodent Models

by Renske Bolder, Susan B. S. King, Roland C. Zahn and Leslie van der Fits

Vaccines 2026, 14(1), 87; https://doi.org/10.3390/vaccines14010087 - 15 Jan 2026

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Abstract

Background/objectives: RSV is a major cause of mortality in infants, and despite recent progress to prevent RSV in the very young, an RSV vaccine for this population is still highly warranted. Clinical studies in infants in the 1960s using formalin-inactivated RSV (FI-RSV) led [...] Read more.

Background/objectives: RSV is a major cause of mortality in infants, and despite recent progress to prevent RSV in the very young, an RSV vaccine for this population is still highly warranted. Clinical studies in infants in the 1960s using formalin-inactivated RSV (FI-RSV) led to life-threatening enhanced respiratory disease (ERD). Therefore, a thorough safety assessment of RSV vaccine candidates intended for RSV seronegative infants is crucial. Methods: Prior to clinical pediatric development of Ad26.RSV.preF, an adenovirus type 26 vector-encoding RSV F protein stabilized in its prefusion conformation, predisposition to ERD was extensively assessed in cotton rat and mouse models. Results: Cotton rats intramuscularly immunized with a wide dose range of Ad26.RSV.preF, including low and sub-protective vaccine doses, and challenged with vaccine homologous RSV A2 or heterologous RSV B Wash 18537, did not show signs of predisposition to ERD. Histopathology scores for alveolitis, peribronchiolitis, interstitial pneumonia, and perivasculitis after challenge were significantly lower for Ad26.RSV.preF-immunized cotton rats compared to FI-RSV-immunized cotton rats and comparable to or lower than scores in cotton rats intranasally pre-exposed to RSV prior to challenge to mimic natural repeated infection. These results were observed in animals with or without viral replication in the lung after RSV challenge, in the presence or absence of vaccine-induced antibodies. Similar results were observed in mice, where more extensive assessment of mono- and polymorphonuclear cell alveolitis, mucus cell hyperplasia, and mucus accumulation was performed. Conclusions: Based on these extensive analyses, we conclude that there are no indications of ERD predisposition after Ad26.RSV.preF vaccination in rodent models, irrespective of the vaccine dose, challenge virus strain, or presence of viral replication in the lung. These results are crucial for the pediatric development of this vaccine. Full article

(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)

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22 pages, 4732 KB

Open AccessArticle

Influenza Vaccine Immunogenicity in Hemodialysis Patients

by Anna-Polina Shurygina, Ekaterina Romanovskaya-Romanko, Vera Krivitskaya, Mariia Sergeeva, Janna Buzitskaya, Kirill Vasilyev, Marina Shuklina, Konstantin Vishnevskii, Smotrov Dmitry, Tutin Aleksey, Dmitry Lioznov and Marina Stukova

Vaccines 2026, 14(1), 63; https://doi.org/10.3390/vaccines14010063 - 4 Jan 2026

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Abstract

Background: Patients with end-stage renal disease (ESRD) on hemodialysis are at increased risk for severe influenza, and underlying immune dysfunction may limit vaccine-induced protection. Methods: This observational open-label study evaluated immune responses in 93 hemodialysis patients vaccinated with seasonal inactivated influenza vaccine (IIV) [...] Read more.

Background: Patients with end-stage renal disease (ESRD) on hemodialysis are at increased risk for severe influenza, and underlying immune dysfunction may limit vaccine-induced protection. Methods: This observational open-label study evaluated immune responses in 93 hemodialysis patients vaccinated with seasonal inactivated influenza vaccine (IIV) during the 2019–2020 (n = 22) and 2023–2024 (n = 71) seasons. Immune responses were comprehensively assessed using hemagglutination inhibition and microneutralization assays to measure antibody levels, together with flow cytometry analysis of key immune cell populations, including plasmablasts, T-follicular helper cells (Tfh), and effector memory T cells (Tem). Results: During the 2019–2020 season, antibody responses in hemodialysis patients were comparable to those in healthy volunteers in both younger (18–60 years) and older (over 60) age groups. By day 7 post-vaccination, there was a pronounced increase in activated Tfh1 cells, coinciding with a surge in plasmablasts and a rise in antigen-specific B cells. This was accompanied by a T-cell response mediated by IFNγ-producing and polyfunctional CD4+ Tem cells. In the 2023–2024 season, revaccination was associated with higher baseline antibody levels but did not alter subsequent response kinetics to A/H1N1pdm, A/H3N2, and B/Yamagata antigens. In contrast, responses to B/Victoria were higher in revaccinated patients throughout the entire observation period. Conclusions: Our findings confirm that standard-dose IIV vaccination is beneficial for hemodialysis patients, inducing robust and adequate humoral and T-cell immune responses. Full article

(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)

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18 pages, 2632 KB

Open AccessArticle

National Near Real-Time Vaccine Effectiveness Against COVID-19 Severe Outcomes Using the Screening Method Among Older Adults Aged ≥50 Years in Canada

by Robert MacTavish, Andreea Slatculescu, Dylan Ermacora, Katarina Vukovojac, Tanner Noth, Natalie Ward, Kathleen Laskoski, Daniela Fleming, Baanu Manoharan, Julie Laroche and Aissatou Fall

Vaccines 2026, 14(1), 26; https://doi.org/10.3390/vaccines14010026 - 24 Dec 2025

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Abstract

Background/Objectives: It is critical to monitor real-world COVID-19 vaccine effectiveness (VE) in older adults, as they have been identified as a priority group for vaccination. This is the first study that aims to estimate national absolute vaccine effectiveness (aVE) against severe COVID-19 outcomes [...] Read more.

Background/Objectives: It is critical to monitor real-world COVID-19 vaccine effectiveness (VE) in older adults, as they have been identified as a priority group for vaccination. This is the first study that aims to estimate national absolute vaccine effectiveness (aVE) against severe COVID-19 outcomes among Canadian older adults aged ≥50 years. Methods: The screening method (SM) was implemented using standard and spline-based logistic regression models to estimate aVE and 95% confidence intervals (CIs) by outcome, age group, vaccination status, time since last dose, vaccine schedules, and variant of concern (VOC) period. Results: From 1 August 2021 to 30 November 2023, there were 103,822 severe COVID-19 cases, of which 72.9% were hospitalized, 8.2% were admitted to ICU, and 18.9% had died. A total of 23.1% of these cases were unvaccinated against COVID-19, 21.9% completed a primary series only, and 55.0% received at least one additional/booster dose. National aVE against severe COVID-19 outcomes remained moderate to high during Delta and original Omicron VOC predominance periods. Monthly age-specific aVE of at least two additional/booster doses remained stable during recombinant XBB.1.5/EG.5 VOC predominance, ranging from 61.0% (95% CI: 51.9–68.4%) to 69.8% (95% CI: 67.5–72.0%) against hospitalization, and 71.0% (95% CI: 62.8–77.4%) to 77.2% (95% CI: 74.2–79.9%) against ICU admission/death. Adjusted aVE was higher for last booster doses received within the past six months and with heterologous mRNA vaccine schedules. Conclusions: The SM is a useful method to estimate aVE in near real-time, enabling the assessment of temporal changes in aVE, guiding vaccine policy, and building vaccine confidence among populations at higher risk of severe outcomes. Full article

(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)

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16 pages, 2515 KB

Open AccessArticle

Spatial Segregation Within Dissolving Microneedle Patches Overcomes Antigenic Interference and Enables Potent Bivalent Influenza–RSV Vaccination in Mice

by Feng Fan, Yehong Wu, Hongzhe Lin, Xin Zhang, Limei Wang, Yue He, Shijie Zhang, Mingju Zhang, Gan Zhao, Rong Xiang, Yating Kang, Mingyue Chen, Zhuang Li, Yi-Bing Guo, Hang Zhou, Chen Zhao, Man-Chuan Wang, Jian-Yang Gu, Bin Wang and Xiao-Ming Gao

Vaccines 2025, 13(12), 1213; https://doi.org/10.3390/vaccines13121213 - 30 Nov 2025

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Abstract

Background/Objectives: Given the overlapping seasonality of influenza (Flu) and respiratory syncytial virus (RSV) infections in human populations, Flu–RSV combination vaccines are urgently needed. However, development of combo-vaccines is often faced with intra-vaccine interference which could compromise vaccination outcomes. Here we present an approach [...] Read more.

Background/Objectives: Given the overlapping seasonality of influenza (Flu) and respiratory syncytial virus (RSV) infections in human populations, Flu–RSV combination vaccines are urgently needed. However, development of combo-vaccines is often faced with intra-vaccine interference which could compromise vaccination outcomes. Here we present an approach to overcoming this problem using a microneedle array patch (MAP)-based combo-vaccine with minimum intra-vaccine interference. Methods: Vaccine-laden dissolving MAPs were fabricated using a two-step micro-molding process with polyvinyl alcohol as major excipient. A partition-loading strategy was adopted to ensure spatially segregated distribution of a split-virus Flu vaccine and recombinant prefusion protein of RSV in separate MAP sectors. Serum samples from BALB/c mice post-vaccination were assessed for titers of binding and neutralizing antibodies against the viruses. Live virus challenge studies were carried out to assess the protection efficacy of the MAP-based vaccines. Results: Although i.m. administered standalone Flu and RSV vaccines were able to induce strong IgG responses in BALB/c mice, bidirectional intra-vaccine interference was observed when the two vaccines were co-administered in premixed form. However, when the two vaccines were loaded onto nonoverlapping sectors of D-MAPs for intradermal vaccination, the intra-vaccine interference effect was effectively overcome. The partition-loaded MAP-Flu/RSV combo-vaccine elicited antigen-specific IgG with robust virus-neutralizing activity and was strongly efficacious against either virus in challenge studies. Conclusions: Our data provide proof-of-concept evidence for the potential usefulness of partition-loaded MAPs in overcoming a critical barrier in vaccinology and offer a promising platform for future clinical translation. Full article

(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)

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16 pages, 2292 KB

Open AccessArticle

Evaluation of the Safety and Efficacy of the Respiratory Syncytial Virus FG Chimeric Vaccine KD-409 in Rodent Models for Maternal and Pediatric Vaccination

by Ryo Yamaue, Madoka Terashima, Kenji Soejima and Masaharu Torikai

Vaccines 2025, 13(11), 1170; https://doi.org/10.3390/vaccines13111170 - 18 Nov 2025

Viewed by 1326

Abstract

Background/Objectives: Respiratory syncytial virus (RSV) causes severe infection in neonates and infants. However, a suitable RSV vaccine for children is yet to be approved. The development of KD-409 is focused on creating an effective and safe RSV vaccine for newborns and children. The [...] Read more.

Background/Objectives: Respiratory syncytial virus (RSV) causes severe infection in neonates and infants. However, a suitable RSV vaccine for children is yet to be approved. The development of KD-409 is focused on creating an effective and safe RSV vaccine for newborns and children. The safety and efficacy of the RSV FG chimeric protein KD-409 were evaluated in several rodent models. Methods/Results: The effect of vaccine-induced antibody transfer was verified in a guinea pig model. Next, the exacerbation of infection was evaluated in a BALB/c mouse model of passive immunity designed to mimic the vaccination of pregnant women. KD-409 did not exacerbate infection when administered with alum, unlike pre-F with alum. Our active immunization model of BALB/c mice, which involved stimulating vaccination with a pediatric vaccine, suggested that KD-409 with alum was less likely to exacerbate inflammation than FI-RSV or pre-F with alum. The efficacy was evaluated in a cotton rat model, in which KD-409 demonstrated greater protection against infection than pre-F without adjuvant, the only currently approved formulation for immunizing pregnant women. Conclusions: KD-409 eliminated concerns about vaccine-enhanced disease in pediatric vaccination and demonstrated superior efficacy to current vaccines in rodent models. The safety in mice during passive and active immunization, and efficacy in cotton rats demonstrate the high potential of KD-409 as a safe and effective next-generation RSV vaccine candidate that can cover the neonatal-to-pediatric age range. Full article

(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)

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15 pages, 2239 KB

Open AccessArticle

Profile of Humoral Immunity and B Cell Pool in Infection with the SARS-CoV-2 Prototype Strain and AZD1222 (ChAdOx nCoV-19) Vaccination

by Débora Familiar-Macedo, Elzinandes Leal de Azeredo, Elba Regina Sampaio de Lemos, Paulo Vieira Damasco and Luzia Maria de-Oliveira-Pinto

Vaccines 2025, 13(2), 101; https://doi.org/10.3390/vaccines13020101 - 21 Jan 2025

Viewed by 2343

Abstract

Background/Objectives: Understanding the behavior of B cells during infection and vaccination is important for determining protective humoral immunity. We evaluated the profile of humoral immunity and B cell pool in individuals who were acutely infected with SARS-CoV-2, recovered from COVID-19, or received two [...] Read more.

Background/Objectives: Understanding the behavior of B cells during infection and vaccination is important for determining protective humoral immunity. We evaluated the profile of humoral immunity and B cell pool in individuals who were acutely infected with SARS-CoV-2, recovered from COVID-19, or received two doses of the AZD1222 vaccine. Methods: Peripheral blood mononuclear cells (PBMCs) from these individuals were subjected to in vitro stimulation to promote the differentiation of B cells into antibody-secreting cells (ASCs), and the ELISpot evaluated the abundance of pan and SARS-CoV-2 Spike S1-reactive IgG+ ASC. Stimulated PBMCs were characterized using flow cytometry. Culture supernatants were assessed for soluble B-cell-activating factors. The IgA and IgG for the S1 were evaluated through ELISA. Results: The recovered individuals displayed a robust S1 ASC compared to acute and vaccinated individuals. Although the frequency of total B cells or B cell subsets did not vary among the groups, plasmablast cells were increased in naïve and double-negative B cells in the acute, recovered, and vaccinated individuals. Similar IgA and IgG production appeared to be present in the acute and recovered individuals. During vaccination, more IgG is produced than IgA. In acute patients, BAFF levels were positively correlated with total B cells and IgG+ plasmablast cells but negatively correlated with IgA+ plasmablast cells. Conclusions: Vaccination and natural infection with COVID-19 induce a differential profile and functionality of B cells. We suggest that new vaccines against COVID-19 incorporate molecular adjuvants that regulate B lymphocyte functionality and consider the beneficial aspects of the IgA response in addition to IgG. Full article

(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)

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21 pages, 5843 KB

Open AccessArticle

Mucosal Immunization with an Influenza Vector Carrying SARS-CoV-2 N Protein Protects Naïve Mice and Prevents Disease Enhancement in Seropositive Th2-Prone Mice

by Mariia V. Sergeeva, Kirill Vasilev, Ekaterina Romanovskaya-Romanko, Nikita Yolshin, Anastasia Pulkina, Daria Shamakova, Anna-Polina Shurygina, Arman Muzhikyan, Dmitry Lioznov and Marina Stukova

Vaccines 2025, 13(1), 15; https://doi.org/10.3390/vaccines13010015 - 28 Dec 2024

Cited by 4 | Viewed by 2218

Abstract

Background/Objectives: Intranasal vaccination enhances protection against respiratory viruses by providing stimuli to the immune system at the primary site of infection, promoting a balanced and effective response. Influenza vectors with truncated NS1 are a promising vaccine approach that ensures a pronounced local CD8+ [...] Read more.

Background/Objectives: Intranasal vaccination enhances protection against respiratory viruses by providing stimuli to the immune system at the primary site of infection, promoting a balanced and effective response. Influenza vectors with truncated NS1 are a promising vaccine approach that ensures a pronounced local CD8+ T-cellular immune response. Here, we describe the protective and immunomodulating properties of an influenza vector FluVec-N carrying the C-terminal fragment of the SARS-CoV-2 nucleoprotein within a truncated NS1 open reading frame. Methods: We generated several FluVec-N recombinant vectors by reverse genetics and confirmed the vector’s genetic stability, antigen expression in vitro, attenuation, and immunogenicity in a mouse model. We tested the protective potential of FluVec-N intranasal immunization in naïve mice and seropositive Th2-prone mice, primed with aluminium-adjuvanted inactivated SARS-CoV-2. Immune response in immunized and challenged mice was analyzed through serological methods and flow cytometry. Results: Double intranasal immunization of naïve mice with FluVec-N reduced weight loss and viral load in the lungs following infection with the SARS-CoV-2 beta variant. Mice primed with alum-adjuvanted inactivated coronavirus experienced substantial early weight loss and eosinophilia in the lungs during infection, demonstrating signs of enhanced disease. A single intranasal boost immunization with FluVec-N prevented the disease enhancement in primed mice by modulating the local immune response. Protection was associated with the formation of specific IgA and the early activation of virus-specific effector and resident CD8+ lymphocytes in mouse lungs. Conclusions: Our study supports the potential of immunization with influenza vector vaccines to prevent respiratory diseases and associated immunopathology. Full article

(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)

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15 pages, 1956 KB

Open AccessArticle

Impact of Anti-SARS-CoV-2 Vaccination on Disease Severity and Clinical Outcomes of Individuals Hospitalized for COVID-19 Throughout Successive Pandemic Waves: Data from an Italian Reference Hospital

by Annalisa Mondi, Ilaria Mastrorosa, Assunta Navarra, Claudia Cimaglia, Carmela Pinnetti, Valentina Mazzotta, Alessandro Agresta, Angela Corpolongo, Alberto Zolezzi, Samir Al Moghazi, Laura Loiacono, Maria Grazia Bocci, Giulia Matusali, Alberto D’Annunzio, Paola Gallì, Fabrizio Maggi, Francesco Vairo, Enrico Girardi and Andrea Antinori

Vaccines 2024, 12(9), 1018; https://doi.org/10.3390/vaccines12091018 - 6 Sep 2024

Cited by 1 | Viewed by 1621

Abstract

This is a retrospective observational study including all COVID-19 patients admitted at our Institute throughout three successive pandemic waves, from January 2021 to June 2023. The main in-hospital outcomes (clinical progression [CP], defined as admission to Intensive Care Unit [ICU]/death, and death within [...] Read more.

This is a retrospective observational study including all COVID-19 patients admitted at our Institute throughout three successive pandemic waves, from January 2021 to June 2023. The main in-hospital outcomes (clinical progression [CP], defined as admission to Intensive Care Unit [ICU]/death, and death within 28 days) were compared among participants unvaccinated (NV), fully vaccinated (FV), with one (FV&B1) and two (FV&B2) booster doses. Vaccinated participants were stratified into recently and waned FV/FV&B1/FV&B2, depending on the time elapsed from last dose (≤ and >120 days, respectively). There were 4488 participants: 2224 NV, 674 FV, 1207 FV&B1, and 383 FV&B2. Within 28 days, there were 604 ICU admissions, 396 deaths, and 737 CP. After adjusting for the main confounders, the risk of both in-hospital outcomes was reduced in vaccinated individuals, especially in those who received the booster dose (approximately by 36% for FV and >50% for FV&B1 and FV&B2 compared to NV). Similarly, after restricting the analysis to vaccinated participants only, we observed a risk reduction of approximately 40% for FV&B1 and 50% for FV&B2, compared to FV, regardless of the distance since the last dose. Our data confirm the vaccine’s effectiveness in preventing severe COVID-19 and support the efforts to increase the uptake of booster doses, mainly among older and frailer individuals, still at a greater risk of clinical progression. Full article

(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)

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Review

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26 pages, 649 KB

Open AccessReview

Challenges and Prospects in the Development of a Universal SARS-CoV-2 Vaccine

by Kacper Karczmarzyk and Małgorzata Kęsik-Brodacka

Vaccines 2026, 14(2), 173; https://doi.org/10.3390/vaccines14020173 - 13 Feb 2026

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Abstract

The development of a universal SARS-CoV-2 vaccine holds great promise for achieving broad and durable protection against existing and future coronavirus variants. The identification, selection, and rational redesign of conserved viral epitopes constitute the direct immunological foundation of universal SARS-CoV-2 vaccine development. The [...] Read more.

The development of a universal SARS-CoV-2 vaccine holds great promise for achieving broad and durable protection against existing and future coronavirus variants. The identification, selection, and rational redesign of conserved viral epitopes constitute the direct immunological foundation of universal SARS-CoV-2 vaccine development. The breadth and durability of protection are therefore primarily determined at the level of antigen and epitope design, whereas adjuvants, delivery platforms, and routes of administration serve as enabling and amplifying components rather than primary drivers of universality. Accordingly, this review discusses key determinants of universal vaccine design, including antigen selection, adjuvant utilization, and route of administration. The spike protein, particularly its receptor-binding domain, is a major antigenic target, but its high mutation rate challenges long-term vaccine efficacy. Strategies focusing on conserved epitopes in antigen designs show potential to elicit cross-neutralizing immune responses. Nanoparticle-based vaccines capable of presenting multiple homologous or heterologous antigens have demonstrated enhanced immunogenicity, broad protection in preclinical models and safety in clinical trials. The addition of next-generation adjuvants further amplifies humoral and cellular immunity beyond the capabilities of traditional aluminum-based adjuvants. Moreover, mucosal vaccine delivery may provide superior local protection at viral entry sites and limit transmission. Importantly, integrating these technological advances with epitope-centered antigen design and immunological data from vaccinated individuals will accelerate the identification of conserved epitopes and inform future vaccine design. A multidisciplinary approach combining optimized antigen engineering, novel adjuvant systems, and innovative delivery strategies is essential for the realization of a broadly protective universal SARS-CoV-2 vaccine. Full article

(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)

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19 pages, 309 KB

Open AccessReview

Cardiopulmonary Effects of COVID-19 Vaccination: A Comprehensive Narrative Review

by Lauren T. Forchette, Luis Palma, Christian Sanchez, Rebecca M. Gibons, Christoph A. Stephenson-Moe and Benjamin J. Behers

Vaccines 2025, 13(6), 548; https://doi.org/10.3390/vaccines13060548 - 22 May 2025

Cited by 1 | Viewed by 21695

Abstract

Coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccines have been associated with numerous side effects since their widespread release to the public. Cardiovascular complications include myocarditis and pericarditis, Takotsubo cardiomyopathy, postural orthostatic tachycardia syndrome (POTS), arrhythmias, sudden cardiac death, and cardiac tamponade. Pulmonary [...] Read more.

Coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccines have been associated with numerous side effects since their widespread release to the public. Cardiovascular complications include myocarditis and pericarditis, Takotsubo cardiomyopathy, postural orthostatic tachycardia syndrome (POTS), arrhythmias, sudden cardiac death, and cardiac tamponade. Pulmonary complications are pulmonary embolism (PE), interstitial lung disease (ILD), idiopathic pulmonary fibrosis (IPF), pneumonia, eosinophilic granulomatosis with polyangiitis, pneumonitis, and pulmonary hypertension. Despite these complications, the risk–benefit analysis still strongly favors vaccination, as these events occur more frequently with natural infection and confer a significantly worse prognosis. This study outlines the evidence surrounding each attributed effect, the clinical course including diagnosis and management, and the proposed pathophysiology. To our knowledge, this is the most comprehensive review of the cardiopulmonary effects of COVID-19 vaccination to date. Full article

(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)

Other

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16 pages, 1348 KB

Open AccessProtocol

A Post-Authorisation Safety Study of a Respiratory Syncytial Virus Vaccine in Pregnant Women and Their Offspring in a Real-World Setting: Generic Protocol for a Target Trial Emulation

by Odette de Bruin, Linda Nab, Jungyeon Choi, Oisin Ryan, Hae-Won Uh, Fariba Ahmadizar, Shahar Shmuel, Heather Rubino, Kitty Bloemenkamp, Cynthia de Luise and Miriam Sturkenboom

Vaccines 2025, 13(3), 272; https://doi.org/10.3390/vaccines13030272 - 5 Mar 2025

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Abstract

Background: Assessing the real-world safety of preventive products against respiratory syncytial virus (RSV) in pregnant women holds significant public health implications, especially as vaccination programs become more widespread. This generic protocol describes a post-authorisation safety study (PASS) to evaluate the safety of RSV [...] Read more.

Background: Assessing the real-world safety of preventive products against respiratory syncytial virus (RSV) in pregnant women holds significant public health implications, especially as vaccination programs become more widespread. This generic protocol describes a post-authorisation safety study (PASS) to evaluate the safety of RSV vaccination in pregnant women using a target trial emulation framework. Methods: This generic protocol, adapted from an ongoing PASS, is designed using the target trial emulation framework to evaluate the safety of an RSV vaccine in pregnant women. Emulating target trial conditions have the ability to minimise confounding and bias. In this pragmatic real-world observational study, RSV-vaccinated pregnant women are matched (1:N) with unexposed women based on gestational age, calendar time, maternal age, immunocompromised status, and high-risk pregnancy. Key adverse outcomes include preterm birth, stillbirth, hypertensive disorders of pregnancy, Guillain-Barré Syndrome (GBS), low birth weight (LBW), and small for gestational age (SGA). Future studies may add additional outcomes per vaccine risk profile and Global Alignment of Immunization safety Assessment (GAIA) recommendations. Distinguishing outcomes measured during pregnancy from those assessed at or after birth is crucial for analysis and interpretation. Conclusions: This protocol offers a structured approach to evaluating the safety of RSV vaccines in pregnant women. It aims to guide researchers in designing studies and should be adapted to specific settings and data availability. Full article

(This article belongs to the Special Issue Evaluation of Vaccine Efficacy, Safety and Immunogenicity Against Influenza, RSV and COVID-19)

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