Clinical Trial: A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines
Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
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
Brief Summary:
This is a randomized, partially observer-blind, dose-escalation, Phase I/II trial evaluating the safety, tolerability, reactogenicity and immunogenicity of investigational RNA-based multivalent vaccine candidates (BNT166a and BNT166c) 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 each substudy, dosing will start with an initial sentinel group, followed by the expansion cohort.
Detailed Summary:
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 two multivalent vaccine candidates (BNT166a and BNT166c) in ~64 healthy participants with no prior history of known or suspected smallpox vaccination (vaccinia-na�ve participants).
Two doses will be given ~31 days apart.
The sponsor may decide to not activate the group with BNT166c, in this case there will be no randomization.
Substudy B is a randomized, observer-blinded and sponsor-unblinded Phase I substudy to assess the reactogenicity, safety and immunogenicity of two multivalent vaccine candidates (BNT166a and BNT166c) in ~32 healthy participants with prior history of smallpox vaccination (vaccinia-experienced).Two doses will be given ~31 days apart.
Participants will be randomized 1:1.
Sponsor may decide to not activate one of the groups, in that case this substudy will be a one group open-label substudy.
Sponsor: BioNTech SE
Current Primary Outcome: For each group
Original Primary Outcome: For each group
Current Secondary Outcome:
Original Secondary Outcome:
Information By: BioNTech SE
Dates:
Date Received: August 04, 2023
Date Started: September 21, 2023
Date Completion: September 21, 2023
Last Updated: November 28, 2023
Last Verified: November 01, 2023
