Bivalent RSVpreF Subunit Vaccine Safety and Immunogenicity in Seropositive 2–<18 Year Olds

Key Points

RSVpreF vaccine demonstrated safety and tolerability across age groups, with adverse events reported in 8-15%.
54% of participants were male, with significant local and systemic reactions noted post-vaccination.
Evaluation used a phase 1 open-label trial design, with RSV neutralizing antibody responses measured 1 month post-vaccination.
Study supports the feasibility of advancing the RSVpreF vaccine in pediatric populations with chronic conditions.

Abstract

Background/Objectives: We aimed to determine safe and immunogenic RSVpreF vaccine dose levels for further clinical development in 2-Methods: The phase 1, age-descending, open-label Picasso trial evaluated different RSVpreF dose levels in respiratory syncytial virus (RSV)-seropositive 2-Results: Overall, 127 participants received RSVpreF 60 µg (2-n = 20; 5-n = 35) or 120 µg (n = 24 and n = 48, respectively); 54% were male and 69% were White. Local reactions and systemic events were reported in 17-20% and 33-45% of 2-Conclusions: RSVpreF was safe, well tolerated, and elicited immune responses in RSV-seropositive 2-<18-year-old participants, supporting further clinical development in this pediatric population, including those with chronic conditions.

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Cite This Study

Glanternik et al. (Wed,) studied this question.

synapsesocial.com/papers/69a75c86c6e9836116a25799 https://doi.org/https://doi.org/10.3390/vaccines14020128

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