Maternal Vaccination for the Prevention of Infantile RSV Disease: An Overview of the Authorized, In-Progress, and Rejected Vaccine Candidates

Overview

Journal Vaccines (Basel)

Date 2024 Sep 28

PMID 39340012

Authors

Georgios Papazisis

Xanthippi Topalidou

Affiliations

Soon will be listed here.

Abstract

Respiratory Syncytial Virus (RSV) continues to pose a significant challenge, contributing to elevated hospitalization rates among children up to 5 years old, with a disproportionate burden on newborns and infants under 6 months old. The unique characteristics of the young immune system make it prone to altered responses to infections and vaccinations, requiring a tailored approach to disease prevention. The recent approval of the maternal RSV vaccine (brand name ABRYSVO) represents a pivotal advancement in preventive strategies among newborns and infants, marking a milestone in RSV research as the first market-approved maternal vaccine. The present review examines clinical trial data on both recent and previous vaccine candidates, as well as the licensed vaccine, focusing on the prevention of RSV disease in newborns and young infants through the passive acquisition of antibodies following maternal immunization. Additionally, it evaluates the safety profile of these vaccines.

References

Walsh E, Falsey A, Zareba A, Jiang Q, Gurtman A, Radley D . Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination. J Infect Dis. 2024; 230(4):e905-e916. PMC: 11481295. DOI: 10.1093/infdis/jiae185. View

Wang X, Li Y, Shi T, Bont L, Chu H, Zar H . Global disease burden of and risk factors for acute lower respiratory infections caused by respiratory syncytial virus in preterm infants and young children in 2019: a systematic review and meta-analysis of aggregated and individual participant data. Lancet. 2024; 403(10433):1241-1253. DOI: 10.1016/S0140-6736(24)00138-7. View

Kampmann B, Madhi S, Munjal I, Simoes E, Pahud B, Llapur C . Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants. N Engl J Med. 2023; 388(16):1451-1464. DOI: 10.1056/NEJMoa2216480. View

Fernandes K, Lim A . Maternal-driven immune education in offspring. Immunol Rev. 2024; 323(1):288-302. DOI: 10.1111/imr.13315. View

Schaerlaekens S, Jacobs L, Stobbelaar K, Cos P, Delputte P . All Eyes on the Prefusion-Stabilized F Construct, but Are We Missing the Potential of Alternative Targets for Respiratory Syncytial Virus Vaccine Design?. Vaccines (Basel). 2024; 12(1). PMC: 10819635. DOI: 10.3390/vaccines12010097. View

Kenmoe S, Chu H, Dawood F, Milucky J, Kittikraisak W, Matthewson H . Burden of Respiratory Syncytial Virus-Associated Acute Respiratory Infections During Pregnancy. J Infect Dis. 2023; 229(Supplement_1):S51-S60. DOI: 10.1093/infdis/jiad449. View

Schmoele-Thoma B, Zareba A, Jiang Q, Maddur M, Danaf R, Mann A . Vaccine Efficacy in Adults in a Respiratory Syncytial Virus Challenge Study. N Engl J Med. 2022; 386(25):2377-2386. DOI: 10.1056/NEJMoa2116154. View

Falsey A, Walsh E, Scott D, Gurtman A, Zareba A, Jansen K . Phase 1/2 Randomized Study of the Immunogenicity, Safety, and Tolerability of a Respiratory Syncytial Virus Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine. J Infect Dis. 2021; 225(12):2056-2066. PMC: 9200152. DOI: 10.1093/infdis/jiab611. View

Graham B, Modjarrad K, McLellan J . Novel antigens for RSV vaccines. Curr Opin Immunol. 2015; 35:30-8. PMC: 4553118. DOI: 10.1016/j.coi.2015.04.005. View

10.

Baral R, Li X, Willem L, Antillon M, Vilajeliu A, Jit M . The impact of maternal RSV vaccine to protect infants in Gavi-supported countries: Estimates from two models. Vaccine. 2020; 38(33):5139-5147. PMC: 7342012. DOI: 10.1016/j.vaccine.2020.06.036. View

11.

Munoz F, Swamy G, Hickman S, Agrawal S, Piedra P, Glenn G . Safety and Immunogenicity of a Respiratory Syncytial Virus Fusion (F) Protein Nanoparticle Vaccine in Healthy Third-Trimester Pregnant Women and Their Infants. J Infect Dis. 2019; 220(11):1802-1815. DOI: 10.1093/infdis/jiz390. View

12.

Arora M, Lakshmi R . Vaccines - safety in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2021; 76:23-40. PMC: 7992376. DOI: 10.1016/j.bpobgyn.2021.02.002. View

13.

Baker J, Aliabadi N, Munjal I, Jiang Q, Feng Y, Brock L . Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age: Results of a randomized phase 3 study. Vaccine. 2024; 42(13):3172-3179. DOI: 10.1016/j.vaccine.2024.03.070. View

14.

August A, Glenn G, Kpamegan E, Hickman S, Jani D, Lu H . A Phase 2 randomized, observer-blind, placebo-controlled, dose-ranging trial of aluminum-adjuvanted respiratory syncytial virus F particle vaccine formulations in healthy women of childbearing age. Vaccine. 2017; 35(30):3749-3759. DOI: 10.1016/j.vaccine.2017.05.045. View

15.

Kollmann T, Kampmann B, Mazmanian S, Marchant A, Levy O . Protecting the Newborn and Young Infant from Infectious Diseases: Lessons from Immune Ontogeny. Immunity. 2017; 46(3):350-363. DOI: 10.1016/j.immuni.2017.03.009. View

16.

Pacheco G, Andrade C, Galvez N, Vazquez Y, Rodriguez-Guilarte L, Abarca K . Characterization of the humoral and cellular immunity induced by a recombinant BCG vaccine for the respiratory syncytial virus in healthy adults. Front Immunol. 2023; 14:1215893. PMC: 10390696. DOI: 10.3389/fimmu.2023.1215893. View

17.

Jones J, Fleming-Dutra K, Prill M, Roper L, Brooks O, Sanchez P . Use of Nirsevimab for the Prevention of Respiratory Syncytial Virus Disease Among Infants and Young Children: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023; 72(34):920-925. PMC: 10468217. DOI: 10.15585/mmwr.mm7234a4. View

18.

Shaw C, Essink B, Harper C, Mithani R, Kapoor A, Dhar R . Safety and Immunogenicity of an mRNA-Based RSV Vaccine Including a 12-Month Booster in a Phase 1 Clinical Trial in Healthy Older Adults. J Infect Dis. 2024; 230(3):e647-e656. PMC: 11420773. DOI: 10.1093/infdis/jiae081. View

19.

Fleming-Dutra K, Jones J, Roper L, Prill M, Ortega-Sanchez I, Moulia D . Use of the Pfizer Respiratory Syncytial Virus Vaccine During Pregnancy for the Prevention of Respiratory Syncytial Virus-Associated Lower Respiratory Tract Disease in Infants: Recommendations of the Advisory Committee on Immunization Practices -.... MMWR Morb Mortal Wkly Rep. 2023; 72(41):1115-1122. PMC: 10578951. DOI: 10.15585/mmwr.mm7241e1. View

20.

Kong K, Krishnaswamy S, Giles M . Maternal vaccinations. Aust J Gen Pract. 2020; 49(10):630-635. DOI: 10.31128/AJGP-02-20-5243. View