NIHR-405: BNT166-01 Study, a research study evaluating the safety and immune response to mRNA vaccine candidates being developed against Monkeypox (also known as mpox)

The Clinical Research Facility would like to invite you to consider taking part in a clinical study of investigational mRNA vaccine candidates against monkeypox (mpox). Participation in the vaccine study is completely voluntary. 

Mpox was previously transmitted to humans from animals in endemic countries. It was an infrequent infection until the outbreak in 2022, when the mpox virus began spreading quickly to various parts of the world, including Europe and North America. This is why the mpox outbreak was declared by the World Health Organization (WHO) a public health emergency of international concern from July 2022 to May 2023.

The mpox vaccine study requires 12 visits to the study site over one year.

Participants in this vaccine study may be reimbursed for study-related travel and other expenses.

Your participation may help doctors to evaluate the safety and immune responses of new potential vaccine candidates against mpox. 

Substudy A

• ARE 18 to 45 years of age
• HAVE a body mass index over 18.5 kg/m2 and under 30 kg/m2 AND weigh at least 50 kg
• Have NO prior history of known or suspected smallpox vaccination and no detectable smallpox vaccination characteristic scar
• Are NOT Pregnant, breastfeeding, planning pregnancy or planning to father children starting from Visit 0 and continuously until 90 d after receiving Dose 2

Substudy B 

• ARE 50 to 65 years of age
• HAVE a body mass index over 18.5 kg/m2 and under 30 kg/m2 AND weigh at least 50 kg
• HAVE a history of prior smallpox vaccination (i.e., are vaccinia-experienced), determined based on medical records and/or presence of smallpox vaccination characteristic scar. The most recent smallpox vaccination should have been received before 1980
• Are NOT Pregnant, breastfeeding, planning pregnancy or planning to father children starting from Visit 0 and continuously until 90 d after receiving Dose 2