A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines
- Registration Number
- NCT05988203
- Lead Sponsor
- BioNTech SE
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 96
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SSB - BNT166a DL2 BNT166a One dose level SSA - BNT166a Dose Level (DL)1 BNT166a One dose level SSA - BNT166a DL2 BNT166a One dose level SSA - BNT166a DL3 BNT166a One dose level SSD - BNT166a BNT166a One dose level based on SSA and SSB data
- Primary Outcome Measures
Name Time Method SSA, SSB, and SSD - Proportion (%) of participants reporting solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) From Dose 1 through Day 7 post-Dose1 inclusive; and from Dose 2 through Day 7 post-Dose 2 inclusive For each group
SSA, SSB, and SSD - Proportion (%) of participants reporting solicited systemic events (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever) From Dose 1 through Day 7 post-Dose1 inclusive; and from Dose 2 through Day 7 post-Dose 2 inclusive For each group
SSA, SSB, and SSD - Proportion (%) of participants with at least one unsolicited adverse event (AE) occurring from Dose 1 through Day 28 post-Dose 1 inclusive From Dose 1 through Day 28 post-Dose 1 inclusive For each group
SSA, SSB, and SSD - Proportion (%) of participants with at least one unsolicited AE occurring from Dose 2 through Day 28 post-Dose 2 inclusive from Dose 2 through Day 28 post-Dose 2 inclusive For each group
SSA, SSB, and SSD - Proportion (%) of participants with at least one serious adverse event (SAE) occurring from Dose 1 through Day 201 post-Dose 1 inclusive From Dose 1 through Day 201 post-Dose 1 inclusive For each group
SSA, SSB, and SSD - Proportion (%) of participants with at least one adverse event of special interest (AESI) occurring from Dose 1 through Day 201 post-Dose 1 inclusive From Dose 1 through Day 201 post-Dose 1 inclusive For each group
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
California Research Foundation
🇺🇸San Diego, California, United States
Alliance for Multispecialty Research, LLC
🇺🇸Knoxville, Tennessee, United States
University of Washington Virology Research Clinic
🇺🇸Seattle, Washington, United States
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Royal Surrey County Hospital Foundation Trust, NIHR Royal Surrey Clinical Research Facility
🇬🇧Guildford, United Kingdom
Guy's and St Thomas' NHS Foundation Trust of St Thomas' Hospital
🇬🇧London, United Kingdom
University Hospital Southampton
🇬🇧Southampton, United Kingdom