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BNT166a

A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines

Ensayo de BioNTech SE en Monkeypox (del registro, en inglés).

Fase

Fase 1/2

Estado

Completado

Participantes

96

previstos

Centros

9

Fin del objetivo primario

ago 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en sep 2023.

Qué mide

Number of Participants Reporting Solicited Local Reactions At the Injection Site (Up to 7 days post any vaccination, and up to 7 days post each vaccination dose (that is, post-dose 1 [up to Day 8]) and post-dose 2 [up to Day 38])) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis was a dose-escalation, Phase I/II study evaluating the safety, tolerability, reactogenicity and immunogenicity of the investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against monkeypox (mpox). This study was originally planned to include four substudies, i.e., substudy A (SSA), substudy B (SSB), substudy C (SSC), and substudy D (SSD). Sponsor decided not to conduct SSC, thus three substudies (SSA, SSB, and SSD) were conducted. In SSA and SSB, dosing started with an initial sentinel group, followed by the expansion cohort. In SSD, dosing was initiated after the interim analysis of SSA and SSB 1-month post-Dose 2 safety, reactogenicity, and immunogenicity data was received. This study was initially planned to investigate two vaccine candidates (the quadrivalent BNT166a and the trivalent BNT166c). The sponsor decided to not activate the groups with BNT166c.

Más ensayos de BNTX

Todos los de BNTX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05988203), actualizada en ago 2026.