Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT165b1 · 1 trial · 1 indication
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain at the injection site, erythema/redness, and induration/swelling. 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. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever. 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. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
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. 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. Participants may have been counted more than once if they reported multiple episodes of the event for the different doses.
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.
MAAE was defined as an AE for which the participants received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. Participants may have been counted more than once if they reported multiple episodes of the event for the different doses.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: BNT165b1: 3 Micrograms (mcg) | EXPERIMENTAL | Participants received 3 intramuscular injections of 3 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively. |
| Cohort 2: BNT165b1: 10 mcg | EXPERIMENTAL | Participants received 3 intramuscular injections of 10 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively. |
| Cohort 3: BNT165b1: 30 mcg | EXPERIMENTAL | Participants received 3 intramuscular injections of 30 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively. |
| Placebo | PLACEBO_COMPARATOR | Participants received 3 intramuscular injections of matching placebo of BNT165b vaccine, one each at Days 1, 57 and 183, respectively. |
| Name | Type | Description |
|---|---|---|
| BNT165b1 | BIOLOGICAL | RNA vaccine for active immunization against malaria administered as intramuscular injection. |
| Placebo | OTHER | Placebo matched to RNA vaccine administered as intramuscular injection. |
Inclusion Criteria: * Had given informed consent by signing and dating the informed consent form (ICF) before initiation of any trial-specific procedures * Were willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to follow good pract...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | Tafenoquine, Primaquine, Chloroquine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
BNT165b1 is an investigational monoclonal antibody being developed for the prevention of malaria. It is currently in Phase 1 clinical development, meaning it has not yet been approved for use. The drug is being studied for its safety and ability to generate immune responses against malaria.
BNT165b1 is being developed by BioNTech SE, a biotechnology company publicly traded under the ticker symbol BNTX. The company is conducting clinical research to evaluate the drug's safety and immunogenicity in healthy volunteers.
BNT165b1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for malaria prevention.
BNT165b1 has one completed clinical trial, NCT05581641, titled 'Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria.' This Phase 1 study enrolled 60 participants in the United States and was a randomized, double-blind, placebo-controlled trial.
BNT165b1 is described as a monoclonal antibody, while the clinical trial NCT05581641 evaluates an RNA-based vaccine against malaria. The trial title refers to an investigational RNA-based vaccine, and BNT165b1 is the drug being studied in that context.