Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial.
J Infect Dis
; 227(6): 761-772, 2023 03 28.
Article
in En
| MEDLINE
| ID: mdl-35904987
ABSTRACT
BACKGROUND:
The aim of this study was to investigate safety and immunogenicity of vaccine formulations against respiratory syncytial virus (RSV) containing the stabilized prefusion conformation of RSV fusion protein (RSVPreF3).METHODS:
This phase 1/2, randomized controlled, observer-blind study enrolled 48 young adults (YAs; aged 18-40 years) and 1005 older adults (OAs; aged 60-80 years) between January and August 2019. Participants were randomized into equally sized groups to receive 2 doses of unadjuvanted (YAs and OAs) or AS01-adjuvanted (OAs) vaccine or placebo 2 months apart. Vaccine safety and immunogenicity were assessed until 1 month (YAs) or 12 months (OAs) after second vaccination.RESULTS:
The RSVPreF3 vaccines boosted humoral (RSVPreF3-specific immunoglobulin G [IgG] and RSV-A neutralizing antibody) responses, which increased in an antigen concentration-dependent manner and were highest after dose 1. Compared to prevaccination, the geometric mean frequencies of polyfunctional CD4+ T cells increased after each dose and were significantly higher in adjuvanted than unadjuvanted vaccinees. Postvaccination immune responses persisted until end of follow-up. Solicited adverse events were mostly mild to moderate and transient. Despite a higher observed reactogenicity of AS01-containing vaccines, no safety concerns were identified for any assessed formulation.CONCLUSIONS:
Based on safety and immunogenicity profiles, the AS01E-adjuvanted vaccine containing 120 µg of RSVPreF3 was selected for further clinical development. CLINICAL TRIALS REGISTRATION NCT03814590.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Respiratory Syncytial Virus, Human
/
Respiratory Syncytial Virus Infections
/
Respiratory Syncytial Virus Vaccines
Type of study:
Clinical_trials
Limits:
Adult
/
Aged
/
Humans
Language:
En
Journal:
J Infect Dis
Year:
2023
Document type:
Article
Affiliation country: