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
Year: 2024
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Source: Clinical Infectious Diseases
Authors: Rebecca Clark, Sam Davies, Jorge Labrador, Paul Loubet, Silvina Natalini Martínez, Helena Moza Moríñigo, Jean-François Nicolas, Mercè Pérez Vera, Mika Rämet, Maria Henar Rebollo-Rodrigo, Iván Sanz-Muñoz, Nancy Dezutter, Sophie Germain, Marie-Pierre David, Amulya Jayadev, Hiwot Amare Hailemariam, Shady Kotb, Nadia Meyer
Institutions: Blackpool Teaching Hospitals NHS Foundation Trust, Hospital Universitario de Burgos, Inserm, Université de Montpellier, Centre Hospitalier Universitaire de Nîmes, Bacterial Virulence and Chronic Infections, Hospital Universitario Fundación Jiménez Díaz, Lyon 1 Université, Hôpital Lyon Sud, Centre International de Recherche en Infectiologie, Tampere University, University of Tampere, Marqués de Valdecilla University Hospital, Instituto de Estudios de Ciencias de la Salud de Castilla y León, GlaxoSmithKline (Belgium), GlaxoSmithKline (India)
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,001
OpenAlex ID: W4401350327