Key result
mRNA-1345 revaccination yields robust RSV antibody responses comparable to primary vaccination.
Why the study?
Protection from a single RSV vaccine dose is not lifelong, and revaccination may be needed to maintain it.
Does revaccination with mRNA-1345 elicit robust immunogenicity and maintain safety in adults aged ≥60 years previously vaccinated with a protein subunit RSV vaccine?
Does revaccination with mRNA-1345 elicit robust immunogenicity and maintain safety in adults aged ≥60 years previously vaccinated with a protein subunit RSV vaccine?
Revaccination with mRNA-1345 at least 12 months after a licensed RSV protein subunit vaccine is safe and elicits robust neutralizing antibody responses comparable to primary vaccination.
Supports revaccination immunogenicity after protein vaccine; leaves open clinical protection and optimal schedules.
Protection from a single RSV vaccine dose is not lifelong, and revaccination may be needed to maintain it. This ongoing, phase 3, open-label trial evaluated revaccination with the RSV vaccine mRNA-1345 ≥12 months after primary vaccination with licensed protein subunit RSV vaccine in adults aged ≥60 years. Primary objectives were safety and immunogenicity. A total of 507 participants were enrolled. Revaccination was well-tolerated, with no safety concerns identified. Robust increases in RSV-A and RSV-B neutralizing antibody geometric mean titers were observed at Day 29. In a post hoc comparison of Day 29 titers following heterologous revaccination with those following primary mRNA-1345 vaccination in a subset of the pivotal efficacy study, geometric mean ratios for RSV-A and RSV-B were 0.952 (95% CI, 0.847-1.070) and 1.087 (95% CI, 0.964-1.226), respectively. These findings support revaccination with mRNA-1345 administered ≥12 months after primary vaccination with a licensed RSV protein subunit vaccine. TRIAL REGISTRATION: NCT07117487.
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Desai et al. (2026) studied RSV vaccination (n=507). mRNA-1345 revaccination vs. Primary mRNA-1345 vaccination (post hoc subset) was evaluated on Safety and immunogenicity (RSV-A and RSV-B neutralizing antibody geometric mean titers at Day 29) (GMR 0.952 (RSV-A), 1.087 (RSV-B), 95% CI 0.847-1.070 (RSV-A), 0.964-1.226 (RSV-B)). Revaccination with mRNA-1345 produced robust antibody responses, with geometric mean ratios of 0.952 (95% CI 0.847-1.070) for RSV-A and 1.087 (95% CI 0.964-1.226) for RSV-B vs primary vaccination.
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