Randomized, Open-Label Phase 3 Study Evaluating Immunogenicity, Safety, and Reactogenicity of RSVPreF3 OA Coadministered with FLU-QIV-HD in Adults Aged ≥ 65.

Autor: Buynak R; Velocity Clinical Research, Valparaiso, IN, USA., Cannon K; Accellacare Clinical Research, Wilmington, NC, USA., DeAtkine D; Ascension St. Vincent's Hospital, Birmingham, AL, USA., Kirby J; Summit Medical Group, Jefferson City, TN, USA., Usdan L; Clinical Neuroscience Solution Healthcare, Memphis, TN, USA., Bhavsar A; GSK Vaccines, Avenue Fleming 20, 1300, Wavre, Belgium., Gérard C; GSK Vaccines, Avenue Fleming 20, 1300, Wavre, Belgium., Kuznetsova A; GSK Vaccines, Avenue Fleming 20, 1300, Wavre, Belgium., Jayadev A; GSK, Bangalore, India., Amare H; GSK Vaccines, Avenue Fleming 20, 1300, Wavre, Belgium., Valenciano S; GSK Vaccines, Avenue Fleming 20, 1300, Wavre, Belgium. sofia.8.valenciano@gsk.com., Meyer N; GSK Vaccines, Avenue Fleming 20, 1300, Wavre, Belgium.
Jazyk: angličtina
Zdroj: Infectious diseases and therapy [Infect Dis Ther] 2024 Aug; Vol. 13 (8), pp. 1789-1805. Date of Electronic Publication: 2024 Jun 26.
DOI: 10.1007/s40121-024-00985-4
Abstrakt: Introduction: Respiratory syncytial virus (RSV) and influenza pose major disease burdens in older adults due to an aging immune system and comorbidities; seasonal overlap exists between these infections. In 2023, the RSV prefusion protein F3 older adult (RSVPreF3 OA) vaccine was first approved in the USA as a single dose for prevention of lower respiratory tract disease due to RSV in adults aged ≥ 60 years. The vaccine has since been approved in the European Union and elsewhere. RSVPreF3 OA and FLU-QIV-HD could be coadministered if immunogenicity, safety, and reactogenicity are not affected.
Methods: This open-label, randomized (1:1), controlled, phase 3 study in 1029 adults aged ≥ 65 years in the USA evaluated the immunogenicity (up to 1 month after last vaccine dose) and safety (up to 6 months after last vaccine dose) of RSVPreF3 OA coadministered with FLU-QIV-HD (co-ad group) versus FLU-QIV-HD alone followed by RSVPreF3 OA at a separate visit 1 month later (control group). Non-inferiority criterion was defined as an upper limit of the two-sided 95% confidence interval of the geometric mean titer (GMT) group ratio (control/co-ad) ≤ 1.5. Secondary endpoints included safety and reactogenicity.
Results: Proportions of participants across age categories between groups and proportions of male (50.4%) and female (49.6%) participants were well balanced; most participants were white (68.7%). Group GMT ratios for RSV-A neutralizing titers, hemagglutination inhibition titers for four influenza vaccine strains, and RSV-B neutralizing titers were non-inferior in the co-ad group versus the control group. No clinically meaningful differences in local or systemic solicited and unsolicited adverse events (AEs), serious AEs, and potential immune-mediated diseases were identified. The most common solicited AEs in both groups were injection-site pain and myalgia.
Conclusion: In adults aged ≥ 65 years, coadministration of RSVPreF3 OA and FLU-QIV-HD was immunogenically non-inferior to the sequential administration of both vaccines 1 month apart, and had clinically acceptable safety and reactogenicity profile.
Trial Registration: ClinicalTrials.gov identifier, NCT05559476.
(© 2024. The Author(s).)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje