Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT166a · 2 trials · 4 indications
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.
All reactogenicity events information recorded via the participant e-diaries or solicited by the investigator were considered as solicited events. Solicited local reactions were: pain at the injection site, erythema/redness, and induration/swelling. Any local reaction indicates participants with any reactions, including reactions that do not qualify for Grade 1 (\<2.5 cm for erythema/redness or induration/swelling). The intensity of local reaction was assessed by the participant and may be confirmed or corrected by the investigator; grades were defined as Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially life-threatening.
All reactogenicity events information recorded via the participant e-diaries or solicited by the investigator were considered as solicited events. Solicited systemic reactions were: fever, chills, fatigue/tiredness, headache, muscle pain/myalgia, joint pain/arthralgia, vomiting, and diarrhea. Any systemic reaction indicated participants with any Grade \>=1 reactions. The intensity of systemic events was assessed by the participants and may be confirmed or corrected by the investigator; grades were defined as Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially life-threatening.
An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. All AE information or safety data including solicited events persisting beyond 7 days that were voluntarily communicated by the participant or collected by the investigator (that is, ECG or laboratory results etc.) were considered unsolicited events. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function Grade 3 - Severe; interferes significantly with the trial participant's usual function; and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required.
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment.
An AESI, serious or non-serious, was one of scientific and medical concern specific to the sponsor's product or program, for which monitoring and rapid communication by the investigator to the sponsor was appropriate.
| 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. |
| BNT166a SSA: 10 mcg | EXPERIMENTAL | Participants received two intramuscular doses of the multivalent RNA-based vaccine BNT166a at Visit 1 (Day 1) and at Visit 5 (Day 31) for active immunization against monkeypox. |
| SSA: BNT166a 30 mcg | EXPERIMENTAL | Participants received two intramuscular doses of the multivalent RNA-based vaccine BNT166a at Visit 1 (Day 1) and at Visit 5 (Day 31) for active immunization against monkeypox. |
| SSA: BNT166a 60 mcg | EXPERIMENTAL | Participants received two intramuscular doses of the multivalent RNA-based vaccine BNT166a at Visit 1 (Day 1) and at Visit 5 (Day 31) for active immunization against monkeypox. |
| SSB: BNT166a 30 mcg | EXPERIMENTAL | Participants received two intramuscular doses of the multivalent RNA-based vaccine BNT166a at Visit 1 (Day 1) and at Visit 5 (Day 31) for active immunization against monkeypox. |
| SSD: BNT166a 60 mcg | EXPERIMENTAL | Participants received two intramuscular doses of the multivalent RNA-based vaccine BNT166a at Visit 1 (Day 1) and at Visit 6 (Day 31) for active immunization against monkeypox. |
| 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. |
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...
BNT166a is an investigational mRNA-based vaccine candidate being developed for the prevention of Mpox (monkeypox) and related Orthopoxvirus infections. It is designed to elicit immune responses against the virus. The vaccine is currently in clinical development and is not yet approved by regulatory authorities.
BNT166a is being developed by BioNTech SE, a biotechnology company traded on the Nasdaq under the ticker symbol BNTX. BioNTech is conducting clinical trials to evaluate the safety and immunogenicity of this vaccine candidate in healthy adult volunteers.
BNT166a is in clinical development, with a completed Phase 1 trial and an ongoing Phase 2 trial. The Phase 2 study is currently recruiting participants in Africa. BNT166a remains investigational and has not received FDA approval or any other regulatory approval.
BNT166a has been studied in two clinical trials. NCT05988203 was a completed Phase 1 study in the United States and United Kingdom. NCT07379580 is an ongoing Phase 2 trial recruiting in the Democratic Republic of the Congo and South Africa, with an enrollment target of 310 participants.
BNT166a is an mRNA-based vaccine candidate. It works by delivering genetic instructions that encode for viral antigens, prompting the body's cells to produce these proteins and stimulate an immune response against the Mpox virus. This approach aims to generate protective immunity without using live virus.