A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity A
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.
| Condition(s) | Mpox (Monkeypox), Smallpox, Orthopoxvirus Infection |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Key Inclusion Criteria (applicable to all participants unless otherwise specified): * 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 2: ≥18 to ≤64 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). Key Exclusion Criteria (applicable to all participants unless otherwise specified): * Have had recent exposure to mpox (defined as close contact with a probable or confirmed case of mpox within the past 28 days, or have evidence of mpox infection or mpox vaccination withi |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | BioNTech SE |
| Locations | Kinshasa, Democratic Republic of the Congo; Kinshasa, Democratic Republic of the Congo; Cape Town, South Africa; Cape Town, South Africa; Cape Town, South Africa; Johannesburg, South Africa |
| Start date | 2026-02-20 |
| NCT ID | NCT07379580 |
| Official listing | https://clinicaltrials.gov/study/NCT07379580 |