Tweet
J Infect Dis
. 2021 Dec 21;jiab611.
doi: 10.1093/infdis/jiab611. Online ahead of print.
Phase 1/2 Randomized Study of the Immunogenicity, Safety and Tolerability of an RSV Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine
Ann R Falsey 1 , Edward E Walsh 1 , Daniel A Scott 2 , Alejandra Gurtman 3 , Agnieszka Zareba 2 , Kathrin U Jansen 3 , William C Gruber 3 , Philip R Dormitzer 3 , Kena A Swanson 3 , Qin Jiang 2 , Emily Gomme 3 , David Cooper 3 , Beate Schmoele-Thoma 4 , C3671001 Study Group
Affiliations
- PMID: 34931667
- DOI: 10.1093/infdis/jiab611
Abstract
Background: Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults and adults with comorbidities. An effective vaccine is needed. An investigational bivalent prefusion F vaccine (RSVpreF) was assessed in healthy adults.
Methods: This phase 1/2 study randomized adults 18-85 years old to receive placebo or 60, 120, or 240 µg RSVpreF (with or without Al[OH]3) alone or concomitantly with seasonal inactivated influenza vaccine (SIIV). Safety and immunogenicity were assessed.
Results: In older adults, reactogenicity events were predominantly mild or moderate among RSVpreF recipients; adverse events through 1 month postvaccination were similar across formulations. Coadministration with SIIV did not appear to affect safety among younger or older adults. All RSVpreF formulations with or without concomitant SIIV elicited robust RSV serum neutralizing responses in adults 50-85 years 1 month postvaccination. Neutralizing titers 1 and 12 months postvaccination were 6.9-14.9- and 2.9-4.5-times, respectively, those before vaccination. SIIV immune responses trended lower when coadministered with RSVpreF.
Conclusions: RSVpreF formulations administered alone or with SIIV were well tolerated and highly immunogenic in older adults, supporting the potential for RSVpreF to protect older adults from RSV disease.
Keywords: F protein; immunogenicity; older adults; respiratory syncytial virus; safety; vaccine.