Mpox
Conditions
Interventions
Placebo
Sponsors
BioNTech SE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. * =18 to =45 years of age (Cohort 1) * =18 to =64 years of age (Cohort 2) 2) NOTE: Other protocol defined Inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: 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 IB. - Have a history of allergies, hypersensitivities, or intolerance to 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 (BMI) =18.5 kg/m^2 or =35 kg/m^2. NOTE: Other protocol defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number (and percentage) of participants with at least one solicited local reaction (pain, erythema/redness, induration/swelling), after each dose of BNT166a at each dose level in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. ;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), after each dose of BNT166a at each dose level in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. ;Number (and percentage) of participants with at least one use of antipyretics/analgesics, after each dose of BNT166a at each dose level in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. ;Number (and percentage) of participants with at least one unsolicited AE, after each dose of BNT166a at each dose level in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. ;Number (and percentage) of participants with at least one unsolicited AE, after each dose of BNT166a at each dose level in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. ;Number (and percentage) of participants with at least one SAE, after each dose of BNT166a at each dose level in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. ;Number (and percentage) of participants with at least one AESI, after each dose of BNT166a at each dose level in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. ;Number (and percentage) of participants with at least one MAAE, after each dose of BNT166a at each dose level in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. ;Number (and percentage) of participants with at least one AE leading to a participant’s withdrawal from the trial, after each dose of BNT166a at each dose level in Orthopoxvirus-naïve (Cohort 1) and Ort | — |
Secondary
| Measure | Time frame |
|---|---|
| BNT166a antigen-specific (A35, B6, H3, and M1) binding antibody titers at each dose level in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. ;MPXV-specific neutralizing antibody titers at each dose level in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. ;VACV-specific neutralizing antibody titers at each dose level in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. | — |
Countries
Democratic Republic of the Congo, South Africa
Contacts
Public ContactMichelle Botha
Associate Director Global Site Activation
Outcome results
None listed