Safety, Reactogenicity, and Immunogenicity of an Mpox mRNA Vaccine Candidate, BNT166a, in Healthy Participants Aged 18 Years and Older in African Countries: A Randomized, Double-blind, Placebo-controlled Phase II Trial
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, reactogenicity, and immunogenicity after one and two doses of BNT166a or placebo in healthy participants.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: t
View:
• Are male or female individuals ≥18 years of age at the time of giving informed consent:
⁃ Cohort 1: ≥18 to ≤45 years of age
• Cohort 1: Participants must be Orthopoxvirus-naïve (have no history of smallpox or mpox vaccination or mpox infection).
• Cohort 2: Participants must be Orthopoxvirus-experienced (have evidence of mpox or smallpox vaccination or mpox infection at least 2 years prior to consent).
Locations
Other Locations
Democratic Republic of the Congo
Institute National de Recherche Biomedicale
NOT_YET_RECRUITING
Kinshasa
University of Kinshasa UNIKIN
NOT_YET_RECRUITING
Kinshasa
South Africa
Desmond Tutu Health Foundation Masiphumelele Clinic
NOT_YET_RECRUITING
Cape Town
TASK Applied Science
NOT_YET_RECRUITING
Cape Town
TREAD Research Pty Ltd
RECRUITING
Cape Town
Perinatal HIV Research Unit
RECRUITING
Johannesburg
Contact Information
Primary
BioNTech clinical trials patient information
patients@biontech.de
+49 6131 9084
Time Frame
Start Date: 2026-02-20
Estimated Completion Date: 2027-06
Participants
Target number of participants: 310
Treatments
Experimental: Cohort 1 - BNT166a Dose Level (DL) 1 (Orthopoxvirus-naïve participants, aged 18-45 years)
Two doses of investigational medicinal product (IMP).
Experimental: Cohort 1 - BNT166a DL 2 (Orthopoxvirus-naïve participants, aged 18-45 years)
Two doses of IMP.
Placebo_comparator: Cohort 1 - Placebo (Orthopoxvirus-naïve participants, aged 18-45 years)
0.9% sodium chloride solution. Two doses of IMP.
Experimental: Cohort 2 - BNT166a DL 1 (Orthopoxvirus-experienced participants, aged 18-64 years)
Two doses of IMP.
Experimental: Cohort 2 - BNT166a DL 2 (Orthopoxvirus-experienced participants, aged 18-64 years)
Two doses of IMP.
Placebo_comparator: Cohort 2 - Placebo (Orthopoxvirus-experienced participants, aged 18-64 years)
0.9% sodium chloride solution. Two doses of IMP.
Sponsors
Collaborators: Coalition for Epidemic Preparedness Innovations
Leads: BioNTech SE