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

Monkeypox Clinical Trial

Official title: A Randomized, Partially Observer-blind, Dose-escalation, Phase I/II Trial Evaluating the Safety and Immunogenicity of Investigational RNA-based Mpox Vaccine Candidates

Status Recruiting

Clinical Trial Summary

This is a dose-escalation, Phase I/II trial evaluating the safety, tolerability, reactogenicity and immunogenicity of the investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against monkeypox (mpox).

This trial will start with the two substudies, i.e., substudy A (SSA) and substudy B (SSB).

This trial will be initiated with the dose-escalation SSA. In substudy A and substudy B, dosing will start 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.

Clinical Trial Description

Substudy A is a 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). Two doses will be given ~31 days apart.

Substudy B is a 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). Two doses will be given ~31 days apart. ;

Related Conditions & MeSH terms

• Monkeypox

• NCT number: NCT05988203
• Study type: Interventional
• Source: BioNTech SE
• Contact: BioNTech clinical trials patient information
• Phone: +49 6131 9084
• Email: patients@biontech.de
• Status: Recruiting
• Phase: Phase 1
• Start date: September 21, 2023
• Completion date: May 2025