A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Im… (NCT07379580) | Clinical Trial Compass
RecruitingPhase 2
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
Democratic Republic of the Congo, South Africa310 participantsStarted 2026-02-20
Plain-language 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
Age range18 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 within 2 years prior to consent).
* Have a contraindication, warning and/or precaution to vaccination with a messenger ribonucleic acid (mRNA) Coronavirus disease 2019 (COVID-19) vaccine as specified in the Summary of Product Characteristics for BNT162b2 (COMIRNATY United States Prescribing Information/European Union Summary of Product Characteristics) and BNT166 Investigator Brochure.
* Have a history of allergies, hypersensitivities, or intolerance to the study treatments including any excipients thereof.
* Have a current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrh…
What they're measuring
1
Number (and percentage) of participants with at least one solicited local reaction (pain, erythema/redness, induration/swelling)
Timeframe: For up to 7 days following each dose
2
Number (and percentage) of participants with at least one solicited systemic reaction (fever, headache, fatigue/tiredness, muscle pain/myalgia, joint pain/arthralgia, chills, diarrhea, vomiting)
Timeframe: For up to 7 days following each dose
3
Number (and percentage) of participants with at least one use of antipyretics/analgesics
Timeframe: For up to 7 days following each dose
4
Number (and percentage) of participants with at least one unsolicited adverse event (AE) (post-Dose 1)
Timeframe: From Dose 1 to 28 days post-Dose 1
5
Number (and percentage) of participants with at least one unsolicited AE (post-Dose 2)
Timeframe: From Dose 2 to 28 days post-Dose 2
6
Number (and percentage) of participants with at least one serious adverse event
Timeframe: From Dose 1 until the end of study, i.e., up to ~14 months
7
Number (and percentage) of participants with at least one AE of special interest