Mpox (Monkeypox), Orthopoxvirus Infection, Smallpox
Conditions
Keywords
Monkeypox virus (MPXV), Active immunization, Ribonucleic acid (RNA) vaccine
Brief 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.
Detailed description
This study will include the following cohorts: * Cohort 1: healthy adults aged 18 to 45 years inclusive who are Orthopoxvirus-naïve. * Cohort 2: healthy adults aged 18 to 64 years inclusive who are Orthopoxvirus-experienced. All participants will receive two doses of BNT166a or placebo at least 28 days apart. The planned study duration per participant is \ 14 months.
Interventions
BIOLOGICALBNT166a
Intramuscular injection. Injections should be given in the deltoid muscle, using the same non-dominant arm for all IMP doses.
OTHERPlacebo
Intramuscular injection. Injections should be given in the deltoid muscle, using the same non-dominant arm for all IMP doses.
Sponsors
BioNTech SE
Coalition for Epidemic Preparedness Innovations
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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: * 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 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 ≤18.5 kg/m\^2 or ≥35 kg/m\^2. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number (and percentage) of participants with at least one solicited local reaction (pain, erythema/redness, induration/swelling) | For up to 7 days following each dose | At each dose level of BNT166a 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) | For up to 7 days following each dose | At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. |
| Number (and percentage) of participants with at least one use of antipyretics/analgesics | For up to 7 days following each dose | At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. |
| Number (and percentage) of participants with at least one unsolicited adverse event (AE) (post-Dose 1) | From Dose 1 to 28 days post-Dose 1 | At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. |
| Number (and percentage) of participants with at least one unsolicited AE (post-Dose 2) | From Dose 2 to 28 days post-Dose 2 | At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. |
| Number (and percentage) of participants with at least one serious adverse event | From Dose 1 until the end of study, i.e., up to ~14 months | At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. |
| Number (and percentage) of participants with at least one AE of special interest | From Dose 1 until the end of study, i.e., up to ~14 months | At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. |
| Number (and percentage) of participants with at least one medically attended AE | From Dose 1 until the end of study, i.e., up to ~14 months | At each dose level of BNT166a 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 study | From Dose 1 until the end of study, i.e., up to ~14 months | At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean titers (GMT) of BNT166a antigen-specific (A35, B6, H3, and M1) binding antibody titers | At baseline, 1 month post-Dose 1, and 1 month post- Dose 2 | At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults, at the defined timepoints. |
| Geometric mean fold rise (GMFR) of BNT166a antigen-specific (A35, B6, H3, and M1) binding antibody titers | At 1 month post-Dose 1 and 1 month post-Dose 2 | At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. Ratio post-baseline/baseline at the defined timepoints. |
| GMT of MPXV-specific neutralizing antibody titers | At baseline, 1 month post-Dose 1, and 1 month post-Dose 2 | At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults, at the defined timepoints. |
| GMFR of MPXV-specific neutralizing antibody titers | At 1 month post-Dose 1 and 1 month post-Dose 2 | At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. Ratio post-baseline/baseline at the defined timepoints. |
| GMT of vaccinia virus (VACV)-specific neutralizing antibody titers | At baseline, 1 month post-Dose 1, and 1 month post-Dose 2 | At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults, at the defined timepoints. |
| GMFR of VACV-specific neutralizing antibody titers | At 1 month post-Dose 1 and 1 month post-Dose 2 | At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. Ratio post-baseline/baseline at the defined timepoints. |
Countries
Democratic Republic of the Congo, South Africa
Contacts
CONTACTBioNTech clinical trials patient information
STUDY_DIRECTORBioNTech Responsible Person
BioNTech SE
Outcome results
None listed