Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT05988203
Brief Summary:
This is 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 started with substudy A (SSA) and substudy B (SSB) for which recruitment has been completed. A Substudy C (SSC) was planned, but the sponsor decided not to conduct it. This study will therefore continue with substudy D (SSD).
In SSA and SSB, dosing started with an initial sentinel group, followed by the expansion cohort.
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.
Detailed Description:
Substudy A is an open-label, dose-escalation, Phase I substudy to assess the reactogenicity, safety, and immunogenicity of up to three dose levels of the multivalent vaccine candidate BNT166a in 48 healthy participants with no prior history of known or suspected smallpox vaccination (vaccinia-naïve participants).
Substudy B is a one group, open-label, Phase I substudy to assess the reactogenicity, safety and immunogenicity of the multivalent vaccine candidate BNT166a in 16 healthy participants with prior history of smallpox vaccination (vaccinia-experienced).
Substudy D is a one group, open-label, Phase IIa substudy to assess the reactogenicity, safety, and immunogenicity of one dose level of BNT166a in \~32 healthy participants with no prior history of known or suspected smallpox vaccination (i.e., vaccinia-naïve participants). SSD will be initiated after the interim analysis of SSA and SSB safety, reactogenicity, and immunogenicity data.
The duration of study participation is \~ 14 months per participant in all of the substudies.
Study:
NCT05988203
Study Brief:
Protocol Section:
NCT05988203