Phase 1/2 Randomized Study of the Immunogenicity, Safety and Tolerability of an RSV Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine

Department

Infectious Diseases

Document Type

Article

Publication Title

Journal of Infectious Diseases

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.

First Page

2056

Last Page

2066

DOI

10.1093/infdis/jiab611

Volume

225

Issue

12

Publication Date

6-15-2022

Comments

See full list of authors at journal website.

PubMed ID

34931667

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