Safety and immunogenicity of mpox vaccine candidates
Research type
Research Study
Full title
A randomized, partially observer-blind, dose-escalation, Phase I/II trial evaluating the safety and immunogenicity of investigational RNA-based mpox vaccine candidates
IRAS ID
1006947
Contact name
Lynsey Kennedy
Contact email
Sponsor organisation
BioNTech SE
Research summary
This is a clinical study investigating the safety and immune responses after immunization with investigational monkeypox vaccines. The study includes 2 substudies A and B.
Substudy A will assess the safety and immunogenicity of up to three dose levels of the vaccine candidate BNT166a and one dose level of the vaccine candidate BNT166c. This substudy will enroll ~64 healthy participants with no prior history of smallpox vaccination.
Substudy B will assess the safety and immunogenicity of one dose level of BNT166a and BNT166c. This substudy will enroll ~32 healthy participants with prior history of smallpox vaccination that will be randomised (selected by chance, like flipping a coin) to one of the two vaccine candidates.
The duration of trial participation will be ~13 months for each participant in all of the substudies. Depending on the safety and immunogenicity data generated in this trial, some substudies/groups may not be initiated or may be terminated earlier. Protocol amendments may be used to allow other substudies or groups to be initiated and/or for other vaccine candidates to be tested.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0182
Date of REC Opinion
24 Jul 2023
REC opinion
Further Information Favourable Opinion