AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa

RecruitingPhase 2Ages 18 Years - 64 YearsAllBioNTech SE
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria (applicable to all participants unless otherwise specified): * Are male or female individuals โ‰ฅ18 years of age at the time of giving informed consent: * Cohort 1: โ‰ฅ18 to โ‰ค45 years of age * Cohort 2: โ‰ฅ18 to โ‰ค64 years of age * Cohort 1: Participants must be Orthopoxvirus-naรฏve (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 arrhythmias. * Have any known bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. * Have a body mass index โ‰ค18.5 kg/m\^2 or โ‰ฅ35 kg/m\^2. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
๐Ÿ’Š

What it tests

  • BNT166a
  • Placebo
๐Ÿ“

Where

6 sites
University of Kinshasa UNIKIN
Kinshasa, Democratic Republic of the Congo
Institute National de Recherche Biomedicale
Kinshasa, Democratic Republic of the Congo
TASK Applied Science
Cape Town, South Africa
TREAD Research Pty Ltd
Cape Town, South Africa
Desmond Tutu Health Foundation Masiphumelele Clinic
Cape Town, South Africa
Perinatal HIV Research Unit
Johannesburg, South Africa
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy