Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination

Overview

Journal J Infect Dis

Publisher Oxford University Press

Specialty Infectious Diseases

Date 2024 Apr 12

PMID 38606958

Authors

Edward E Walsh

Ann R Falsey

Agnieszka M Zareba

Qin Jiang

Alejandra Gurtman

David Radley

Emily Gomme

David Cooper

Kathrin U Jansen

William C Gruber

Kena A Swanson

Beate Schmoele-Thoma

Affiliations

Soon will be listed here.

Abstract

Background: Respiratory syncytial virus (RSV) causes substantial respiratory disease. Bivalent RSV prefusion F (RSVpreF) vaccine is licensed in ≥60-year-olds. RSVpreF was well tolerated and immunogenic in a phase 1/2 study. We evaluated antibody persistence after initial vaccination and safety and immunogenicity after revaccination from this study.

Methods: Healthy adults were randomized to receive initial vaccination and revaccination 12 months later with either placebo or RSVpreF (240 µg with or without aluminum hydroxide). RSV-A and RSV-B geometric mean neutralizing titers (GMTs) were measured through 12 months after both vaccinations. Tolerability and safety were assessed.

Results: There were 263 participants revaccinated (18-49 years old, n = 134; 65-85 years old, n = 129). Among 18- to 49-year-olds and 65- to 85-year-olds, geometric mean fold rises (GMFRs) for both RSV subgroups (RSV-A, RSV-B) 1 month after initial RSVpreF vaccination were 13.3 to 20.4 and 8.9 to 15.5, respectively, as compared with levels before initial vaccination; corresponding GMFRs 12 months after initial vaccination were 4.1 to 5.0 and 2.6 to 4.1. GMFRs 1 month after revaccination vs levels before revaccination were 1.4 to 2.3 and 1.4 to 2.2 for 18- to 49-year-olds and 65- to 85-year-olds. Peak GMTs after revaccination were lower than those after initial vaccination. GMTs 12 months after initial vaccination and revaccination were similar, with GMFRs ranging from 0.7 to 1.6. No safety signals occurred.

Conclusions: RSVpreF revaccination was immunogenic and well tolerated among adults. Clinical Trials Registration. NCT03529773 (ClinicalTrials.gov).

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References

Choi Y, Hill-Ricciuti A, Branche A, Sieling W, Saiman L, Walsh E . Cost determinants among adults hospitalized with respiratory syncytial virus in the United States, 2017-2019. Influenza Other Respir Viruses. 2021; 16(1):151-158. PMC: 8692803. DOI: 10.1111/irv.12912. View

Li Y, Johnson E, Shi T, Campbell H, Chaves S, Commaille-Chapus C . National burden estimates of hospitalisations for acute lower respiratory infections due to respiratory syncytial virus in young children in 2019 among 58 countries: a modelling study. Lancet Respir Med. 2020; 9(2):175-185. DOI: 10.1016/S2213-2600(20)30322-2. View

Curran D, Cabrera E, Bracke B, Raymond K, Foster A, Umanzor C . Impact of respiratory syncytial virus disease on quality of life in adults aged ≥50 years: A qualitative patient experience cross-sectional study. Influenza Other Respir Viruses. 2022; 16(3):462-473. PMC: 8983922. DOI: 10.1111/irv.12929. View

Li Y, Wang X, Blau D, Caballero M, Feikin D, Gill C . Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet. 2022; 399(10340):2047-2064. PMC: 7613574. DOI: 10.1016/S0140-6736(22)00478-0. View

Thompson M, Naleway A, Fry A, Ball S, Spencer S, Reynolds S . Effects of Repeated Annual Inactivated Influenza Vaccination among Healthcare Personnel on Serum Hemagglutinin Inhibition Antibody Response to A/Perth/16/2009 (H3N2)-like virus during 2010-11. Vaccine. 2016; 34(7):981-8. PMC: 5218812. DOI: 10.1016/j.vaccine.2015.10.119. View

Baber J, Arya M, Moodley Y, Jaques A, Jiang Q, Swanson K . A Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults. J Infect Dis. 2022; 226(12):2054-2063. PMC: 9749002. DOI: 10.1093/infdis/jiac189. View

Pastula S, Hackett J, Coalson J, Jiang X, Villafana T, Ambrose C . Hospitalizations for Respiratory Syncytial Virus Among Adults in the United States, 1997-2012. Open Forum Infect Dis. 2017; 4(1):ofw270. PMC: 5414053. DOI: 10.1093/ofid/ofw270. View

Walsh E . Respiratory Syncytial Virus Infection: An Illness for All Ages. Clin Chest Med. 2017; 38(1):29-36. PMC: 5844562. DOI: 10.1016/j.ccm.2016.11.010. View

Schwarz T, Hwang S, Ylisastigui P, Liu C, Takazawa K, Yono M . Immunogenicity and Safety Following 1 Dose of AS01E-Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults: A Phase 3 Trial. J Infect Dis. 2024; 230(1):e102-e110. PMC: 11272088. DOI: 10.1093/infdis/jiad546. View

10.

Fox A, Carolan L, Leung V, Phuong H, Khvorov A, Auladell M . Opposing Effects of Prior Infection versus Prior Vaccination on Vaccine Immunogenicity against Influenza A(H3N2) Viruses. Viruses. 2022; 14(3). PMC: 8949461. DOI: 10.3390/v14030470. View

11.

Branche A, Saiman L, Walsh E, Falsey A, Sieling W, Greendyke W . Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017-2020. Clin Infect Dis. 2021; 74(6):1004-1011. DOI: 10.1093/cid/ciab595. View

12.

Walsh E, Marc G, Zareba A, Falsey A, Jiang Q, Patton M . Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults. N Engl J Med. 2023; 388(16):1465-1477. DOI: 10.1056/NEJMoa2213836. View

13.

Leung V, Carolan L, Worth L, Harper S, Peck H, Tilmanis D . Influenza vaccination responses: Evaluating impact of repeat vaccination among health care workers. Vaccine. 2017; 35(19):2558-2568. DOI: 10.1016/j.vaccine.2017.03.063. View

14.

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

15.

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

16.

Falsey A, Hennessey P, Formica M, Cox C, Walsh E . Respiratory syncytial virus infection in elderly and high-risk adults. N Engl J Med. 2005; 352(17):1749-59. DOI: 10.1056/NEJMoa043951. View

17.

McLaughlin J, Khan F, Begier E, Swerdlow D, Jodar L, Falsey A . Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis. Open Forum Infect Dis. 2022; 9(7):ofac300. PMC: 9301578. DOI: 10.1093/ofid/ofac300. View

18.

Nabeshima S, Kashiwagi K, Murata M, Kanamoto Y, Furusyo N, Hayashi J . Antibody response to influenza vaccine in adults vaccinated with identical vaccine strains in consecutive years. J Med Virol. 2007; 79(3):320-5. DOI: 10.1002/jmv.20801. View

19.

Branche A, Saiman L, Walsh E, Falsey A, Jia H, Barrett A . Change in functional status associated with respiratory syncytial virus infection in hospitalized older adults. Influenza Other Respir Viruses. 2022; 16(6):1151-1160. PMC: 9530534. DOI: 10.1111/irv.13043. View

20.

Athan E, Baber J, Quan K, Scott R, Jaques A, Jiang Q . Safety and Immunogenicity of Bivalent RSVpreF Vaccine Coadministered With Seasonal Inactivated Influenza Vaccine in Older Adults. Clin Infect Dis. 2023; 78(5):1360-1368. PMC: 11093669. DOI: 10.1093/cid/ciad707. View