A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine.
J Infect Dis
; 225(8): 1357-1366, 2022 04 19.
Article
en En
| MEDLINE
| ID: mdl-34932102
ABSTRACT
BACKGROUND:
Protection against human respiratory syncytial virus (RSV) remains an unmet need potentially addressable by maternal immunization. This phase 1/2 study evaluated a bivalent prefusion F vaccine (RSVpreF) with antigens from RSV subgroups A and B.METHODS:
Adults 18-49 years old (Nâ =â 618) were randomized to receive placebo or 60, 120, or 240 µg RSVpreF with or without Al(OH)3. Safety and immunogenicity were evaluated.RESULTS:
RSVpreF recipients more frequently reported local reactions and systemic events than placebo recipients; these were mostly mild or moderate. No vaccine-related serious adverse events occurred through 12 months postvaccination. All RSVpreF formulations induced 1-month postvaccination virus-neutralizing titers higher than those associated with protection of high-risk infants by palivizumab, the only prophylactic currently available for RSV. Geometric mean fold rises (GMFRs) across RSVpreF doses/formulations were 10.6-16.9 for RSV A and 10.3-19.8 for RSV B at 1 month postvaccination, greater than those historically elicited by postfusion F vaccines. GMFRs were 3.9-5.2 and 3.7-5.1, respectively, at 12 months postvaccination.CONCLUSIONS:
RSVpreF formulations were safe, well tolerated, and induced robust neutralizing responses in adults. These findings support development of RSVpreF, which is being evaluated in a pivotal phase 3 study for maternal immunization. CLINICAL TRIALS REGISTRATION NCT03529773.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Virus Sincitial Respiratorio Humano
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Infecciones por Virus Sincitial Respiratorio
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Vacunas contra Virus Sincitial Respiratorio
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
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Adult
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Humans
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Middle aged
Idioma:
En
Revista:
J Infect Dis
Año:
2022
Tipo del documento:
Article
País de afiliación:
Estados Unidos