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BNT166a

Phase 1

Monkeypox | Monoclonal antibody | Other |BioNTech SE|Last Updated: Mar 27, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment96
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05988203A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox VaccinesPHASE1 COMPLETED 96 — — Sep 21, 2023Mar 4, 2026Mar 27, 20269 United States, United Kingdom
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Study Endpoints
Primary Endpoints
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

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
SSA - BNT166a Dose Level (DL)1EXPERIMENTALOne dose level
SSA - BNT166a DL2EXPERIMENTALOne dose level
SSA - BNT166a DL3EXPERIMENTALOne dose level
SSB - BNT166a DL2EXPERIMENTALOne dose level
SSD - BNT166aEXPERIMENTALOne dose level based on SSA and SSB data
Interventions
NameTypeDescription
BNT166aBIOLOGICALMultivalent ribonucleic acid (RNA)-based vaccine for active immunization against monkeypox administered as intramuscular injection.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites9

Inclusion Criteria (applicable to all substudies unless otherwise specified): * Have given informed consent by signing and dating the informed consent form (ICF) before initiation of any study-specific procedures. * Are willing and able to comply with scheduled visits, treatment schedule, laborator...

Countries:United StatesUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT05988203TRIAL_REMOVED: changed
LOWMay 24, 2026NCT05988203studyFirstPostDate: changed