18 June 2024 | Jaya Goswami, Abdullah H. Baqui, Pablo A. Doreski, Gonzalo Perez Marc, Gilberto Jimenez, Salahuddin Ahmed, Khalequz Zaman, Christopher J. A. Duncan, Mugen Ujije, Mika Rämet, Lina Pérez-Breva, Lan Lan, Jiejun Du, Archana Kapoor, Shraddha Mehta, Joanne E. Tomassini, Wenmei Huang, Honghong Zhou, Sonia K. Stoszek, Frances Priddy, Nina Lin, Nancy Le Cam, Christine A. Shaw, Karen Slobod, Eleanor Wilson, Jacqueline M. Miller, Rituparna Das
The study evaluated the humoral immunogenicity of the mRNA-1345 vaccine in older adults (≥60 years) following a single dose. The trial, ConquerRSV, was a randomized, double-blind, placebo-controlled phase 2/3 study. Participants were randomly assigned to receive either the mRNA-1345 vaccine (50 μg encoding prefusion F glycoprotein) or a placebo. Neutralizing antibody (nAb) and pref binding antibody (bAb) levels were assessed at baseline and day 29 post-vaccination in a per-protocol immunogenicity subset (PPIs).
Key findings include:
- Day 29 nAb geometric mean titers (GMTs) increased 8.4-fold against RSV-A and 5.1-fold against RSV-B from baseline.
- Seroreponses (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 seroreponse 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.
The study concluded that 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 preventing RSV disease.The study evaluated the humoral immunogenicity of the mRNA-1345 vaccine in older adults (≥60 years) following a single dose. The trial, ConquerRSV, was a randomized, double-blind, placebo-controlled phase 2/3 study. Participants were randomly assigned to receive either the mRNA-1345 vaccine (50 μg encoding prefusion F glycoprotein) or a placebo. Neutralizing antibody (nAb) and pref binding antibody (bAb) levels were assessed at baseline and day 29 post-vaccination in a per-protocol immunogenicity subset (PPIs).
Key findings include:
- Day 29 nAb geometric mean titers (GMTs) increased 8.4-fold against RSV-A and 5.1-fold against RSV-B from baseline.
- Seroreponses (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 seroreponse 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.
The study concluded that 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 preventing RSV disease.