1. Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion F Protein Vaccine when Co-administered with Adjuvanted Seasonal Quadrivalent Influenza Vaccine in Older Adults: A Phase 3 Randomized Trial.
- Author
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Clark, Rebecca, Davies, Sam, Labrador, Jorge, Loubet, Paul, Martínez, Silvina Natalini, Moríñigo, Helena Moza, Nicolas, Jean-François, Vera, Mercè Pérez, Rämet, Mika, Rebollo-Rodrigo, Maria Henar, Sanz-Muñoz, Iván, Dezutter, Nancy, Germain, Sophie, David, Marie-Pierre, Jayadev, Amulya, Hailemariam, Hiwot Amare, Kotb, Shady, and Meyer, Nadia
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PATIENT safety , *RESEARCH funding , *INFLUENZA vaccines , *IMMUNOGLOBULINS , *STATISTICAL sampling , *RESPIRATORY syncytial virus infections , *RANDOMIZED controlled trials , *CELLULAR immunity , *DESCRIPTIVE statistics , *HEMAGGLUTINATION tests , *VACCINE immunogenicity , *VIRAL vaccines , *CONFIDENCE intervals , *IMMUNOMODULATORS , *OLD age - Abstract
Background We evaluated co-administration of adjuvanted seasonal quadrivalent influenza vaccine (FLU-aQIV) and respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVPreF3 OA) in ≥65-year-olds. Methods This phase 3, open-label trial randomized ≥65-year-olds to receive FLU-aQIV and RSVPreF3 OA concomitantly (Co-Ad) or sequentially, 1 month apart (Control). Primary objectives were to demonstrate the non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration in terms of hemagglutination inhibition (HI) titers for each FLU-aQIV strain and RSV-A and RSV-B neutralization titers, 1 month post-vaccination. Reactogenicity and safety were also assessed. Results Overall, 1045 participants were vaccinated (Co-Ad: 523; Control: 522). Non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration was demonstrated in terms of HI titers for the A/Victoria(H1N1), B/Victoria, and B/Yamagata influenza strains and RSV-A neutralization titers (upper limits [ULs] of 95% confidence intervals [CIs] for adjusted geometric mean titer [GMT] ratios [Control/Co-Ad] ≤1.50) but not for A/Darwin(H3N2) HI titers (95% CI UL = 1.53). The immune response to A/Darwin(H3N2) was further assessed post-hoc using a microneutralization assay; the post-vaccination adjusted GMT ratio (Control/Co-Ad) was 1.23 (95% CI: 1.06–1.42, ie, UL ≤1.50), suggesting an adequate immune response to A/Darwin(H3N2) following co-administration. RSV-B neutralization titers were comparable between groups (95% CI UL for adjusted GMT ratio ≤1.50). Solicited adverse events were mostly mild or moderate and transient; unsolicited and serious adverse event rates were balanced between groups. Conclusions Adjuvanted FLU-aQIV and RSVPreF3 OA had acceptable reactogenicity/safety profiles when co-administered in ≥65-year-olds, without clinically relevant interference with the immune responses to either vaccine. Clinical Trials Registration NCT05568797 [ABSTRACT FROM AUTHOR]
- Published
- 2024
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