Investigational Monkeypox Vaccines for Monkeypox
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol mentions that certain medications are prohibited, but it does not specify which ones. It is best to discuss your current medications with the study team to see if any adjustments are needed.
Will I have to stop taking my current medications?
The trial protocol mentions that certain medications are prohibited during the study, but it does not specify which ones. It is best to discuss your current medications with the study team to determine if any changes are needed.
What data supports the effectiveness of the treatment BNT166a, BNT166a, BNT166c, BNT166c, BNT166c for monkeypox?
What data supports the effectiveness of the drug BNT166a, BNT166a, BNT166c, BNT166c, BNT166c for monkeypox?
What safety data exists for investigational monkeypox vaccines like BNT166a and BNT166c?
How does the drug BNT166a, BNT166c differ from other treatments for monkeypox?
The investigational drug BNT166a, BNT166c is unique because it is being specifically developed for monkeypox, whereas existing vaccines like JYNNEOS and LC16m8 were originally designed for smallpox and adapted for monkeypox. This drug may offer a novel approach by potentially targeting specific components of the monkeypox virus, unlike the broader smallpox vaccines.1241112
Research Team
BioNTech Responsible Person
Principal Investigator
BioNTech SE
Eligibility Criteria
This trial is for healthy adults with a BMI between 18.5 and 30 kg/m^2, weighing at least 50 kg, without prior smallpox vaccination (ages 18-45) or with past vaccination before 1980 (ages 50-65). Participants must not have immune deficiencies, uncontrolled diseases, recent vaccinations outside the study, or be pregnant. They should agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the investigational RNA-based multivalent vaccine candidate BNT166a in a dose-escalation manner
Follow-up
Participants are monitored for safety, reactogenicity, and immunogenicity after receiving the vaccine
Treatment Details
Interventions
- BNT166a
- BNT166c
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioNTech SE
Lead Sponsor
Prof. Dr. Ugur Sahin
BioNTech SE
Chief Executive Officer since 2008
MD from University of Cologne
Prof. Özlem Türeci
BioNTech SE
Chief Medical Officer since 2018
MD from Saarland University