Humoral Immunogenicity of mRNA-1345 RSV Vaccine in Older Adults

Abstract Background The mRNA-1345 vaccine demonstrated efficacy against respiratory syncytial virus (RSV) disease with acceptable safety in adults aged ≥60 years in the ConquerRSV trial. Here, humoral immunogenicity results from the trial are presented. Methods This phase 2/3 trial randomly assigned...

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Vydáno v:	The Journal of infectious diseases Ročník 230; číslo 5; s. e996 - e1006
Hlavní autoři:	Goswami, Jaya, Baqui, Abdullah H, Doreski, Pablo A, Perez Marc, Gonzalo, Jimenez, Gilberto, Ahmed, Salahuddin, Zaman, Khalequz, Duncan, Christopher J A, Ujiie, Mugen, Rämet, Mika, Pérez–Breva, Lina, Lan, Lan, Du, Jiejun, Kapoor, Archana, Mehta, Shraddah, Tomassini, Joanne E, Huang, Wenmei, Zhou, Honghong, Stoszek, Sonia K, Priddy, Frances, Lin, Nina, Le Cam, Nancy, Shaw, Christine A, Slobod, Karen, Wilson, Eleanor, Miller, Jacqueline M, Das, Rituparna
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	US Oxford University Press 15.11.2024
Témata:	Aged Aged, 80 and over Antibodies, Neutralizing - blood Antibodies, Neutralizing - immunology Antibodies, Viral - blood Antibodies, Viral - immunology Double-Blind Method Female Humans Immunity, Humoral Immunogenicity, Vaccine Male Middle Aged mRNA Vaccines Respiratory Syncytial Virus Infections - immunology Respiratory Syncytial Virus Infections - prevention & control Respiratory Syncytial Virus Vaccines - administration & dosage Respiratory Syncytial Virus Vaccines - genetics Respiratory Syncytial Virus Vaccines - immunology Respiratory Syncytial Virus, Human - genetics Respiratory Syncytial Virus, Human - immunology neutralizing antibody binding antibody RSV mRNA-1345 immunogenicity
ISSN:	0022-1899, 1537-6613, 1537-6613
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Shrnutí:	Abstract Background The mRNA-1345 vaccine demonstrated efficacy against respiratory syncytial virus (RSV) disease with acceptable safety in adults aged ≥60 years in the ConquerRSV trial. Here, humoral immunogenicity results from the trial are presented. Methods This phase 2/3 trial randomly assigned adults (≥60 years) to mRNA-1345 50-µg encoding prefusion F (preF) glycoprotein (n = 17 793) vaccine or placebo (n = 17 748). RSV-A and RSV-B neutralizing antibody (nAb) and preF binding antibody (bAb) levels at baseline and day 29 postvaccination were assessed in a per-protocol immunogenicity subset (PPIS; mRNA-1345, n = 1515; placebo, n = 333). Results Day 29 nAb geometric mean titers (GMTs) increased 8.4-fold against RSV-A and 5.1-fold against RSV-B from baseline. Seroresponses (4-fold rise from baseline) in the mRNA-1345 groups were 74.2% and 56.5% for RSV-A and RSV-B, respectively. Baseline GMTs were lower among participants who met the seroresponse criteria than those who did not. mRNA-1345 induced preF bAbs at day 29, with a pattern similar to nAbs. Day 29 antibody responses across demographic and risk subgroups were generally consistent with the overall PPIS. Conclusions mRNA-1345 enhanced RSV-A and RSV-B nAbs and preF bAbs in adults (≥60 years) across various subgroups, including those at risk for severe disease, consistent with its demonstrated efficacy in the prevention of RSV disease. Clinical Trials Registration NCT05127434. mRNA-1345 vaccine enhanced levels of RSV-A and RSV-B neutralizing antibody and preF binding antibody compared with placebo in adults (≥60 years) across various subgroups, including those at risk for severe disease, consistent with its demonstrated efficacy in the prevention of RSV disease.
Bibliografie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	0022-1899 1537-6613 1537-6613
DOI:	10.1093/infdis/jiae316