BNT166a (Ph 2) for Mpox (Monkeypox) | BioNTech SE | BiopharmaWatch

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BNT166a

Phase 2

Mpox (Monkeypox) | Monoclonal antibody | Infectious Disease |BioNTech SE|Last Updated: Jul 14, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC

Total Trials1

Total Enrollment310

FDA Designations

No designations recorded

Clinical trial landscape

BNT166a · 2 trials · 4 indications

Phase 2 1Phase 1 1

Indication

NCT07379580A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in AfricaMpox (Monkeypox)

RECRUITING310 Analytics

PHASE2RECRUITING

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

Mpox (Monkeypox)

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Study Endpoints

Primary Endpoints

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.

SSA, SSB, and SSD - Proportion (%) of participants reporting solicited local reactions at the injection site (pain, erythema/redness, induration/swelling)

From Dose 1 through Day 7 post-Dose1 inclusive; and from Dose 2 through Day 7 post-Dose 2 inclusive

For each group

SSA, SSB, and SSD - Proportion (%) of participants reporting solicited systemic events (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever)

From Dose 1 through Day 7 post-Dose1 inclusive; and from Dose 2 through Day 7 post-Dose 2 inclusive

For each group

SSA, SSB, and SSD - Proportion (%) of participants with at least one unsolicited adverse event (AE) occurring from Dose 1 through Day 28 post-Dose 1 inclusive

From Dose 1 through Day 28 post-Dose 1 inclusive

For each group

SSA, SSB, and SSD - Proportion (%) of participants with at least one unsolicited AE occurring from Dose 2 through Day 28 post-Dose 2 inclusive

from Dose 2 through Day 28 post-Dose 2 inclusive

For each group

SSA, SSB, and SSD - Proportion (%) of participants with at least one serious adverse event (SAE) occurring from Dose 1 through Day 201 post-Dose 1 inclusive

From Dose 1 through Day 201 post-Dose 1 inclusive

For each group

SSA, SSB, and SSD - Proportion (%) of participants with at least one adverse event of special interest (AESI) occurring from Dose 1 through Day 201 post-Dose 1 inclusive

From Dose 1 through Day 201 post-Dose 1 inclusive

For each group

Secondary Endpoints

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

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

GMT of MPXV-specific neutralizing antibody titers

At baseline, 1 month post-Dose 1, and 1 month post-Dose 2

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Study Design & Arms

AllocationRANDOMIZED

MaskingQUADRUPLE

ModelPARALLEL

PurposePREVENTION

Treatment Arms

Arm	Type	Description
Cohort 1 - BNT166a Dose Level (DL) 1 (Orthopoxvirus-naïve participants, aged 18-45 years)	EXPERIMENTAL	Two doses of investigational medicinal product (IMP).
Cohort 1 - BNT166a DL 2 (Orthopoxvirus-naïve participants, aged 18-45 years)	EXPERIMENTAL	Two doses of IMP.
Cohort 1 - Placebo (Orthopoxvirus-naïve participants, aged 18-45 years)	PLACEBO_COMPARATOR	0.9% sodium chloride solution. Two doses of IMP.
Cohort 2 - BNT166a DL 1 (Orthopoxvirus-experienced participants, aged 18-64 years)	EXPERIMENTAL	Two doses of IMP.
Cohort 2 - BNT166a DL 2 (Orthopoxvirus-experienced participants, aged 18-64 years)	EXPERIMENTAL	Two doses of IMP.
Cohort 2 - Placebo (Orthopoxvirus-experienced participants, aged 18-64 years)	PLACEBO_COMPARATOR	0.9% sodium chloride solution. Two doses of IMP.
SSA - BNT166a Dose Level (DL)1	EXPERIMENTAL	One dose level
SSA - BNT166a DL2	EXPERIMENTAL	One dose level
SSA - BNT166a DL3	EXPERIMENTAL	One dose level
SSB - BNT166a DL2	EXPERIMENTAL	One dose level
SSD - BNT166a	EXPERIMENTAL	One dose level based on SSA and SSB data

Interventions

Name	Type	Description
BNT166a	BIOLOGICAL	Intramuscular injection. Injections should be given in the deltoid muscle, using the same non-dominant arm for all IMP doses.
Placebo	OTHER	Intramuscular injection. Injections should be given in the deltoid muscle, using the same non-dominant arm for all IMP doses.

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Eligibility Criteria

Age Range18 Years to 64 Years

SexALL

Healthy VolunteersYes

Study Sites6

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-n...

Countries:Democratic Republic of the CongoSouth AfricaUnited StatesUnited Kingdom

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Recent Changes (Last 90 Days)

LOWJul 14, 2026NCT07379580lastUpdatePostDate: changed

LOWJul 14, 2026NCT07379580lastUpdatePostDate: changed

LOWJul 9, 2026NCT07379580lastUpdatePostDate: changed

LOWJul 9, 2026NCT07379580lastUpdatePostDate: changed

MEDIUMMay 26, 2026NCT05988203TRIAL_REMOVED: changed

LOWMay 26, 2026NCT07379580primaryCompletionDate: changed

LOWMay 24, 2026NCT07379580studyFirstPostDate: changed

LOWMay 24, 2026NCT05988203studyFirstPostDate: changed