Biontech SE (($CC:BNTX.CUR)), Biontech Se Sponsored Adr ((BNTX)) announced an update on their ongoing clinical study.
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BioNTech SE is conducting a Phase Ia clinical trial titled ‘A Phase Ia, Randomized, Placebo-controlled, Double-blind, Dose-finding Evaluation Trial to Describe the Safety, Reactogenicity, and Immunogenicity of Two Investigational Vaccines Against Tuberculosis in IGRA-negative, BCG naïve Subjects.’ The study aims to evaluate the safety and immune responses of two investigational RNA-based vaccines, BNT164a1 and BNT164b1, against tuberculosis in healthy volunteers. This research is significant as it explores new preventive measures against tuberculosis, a major global health concern.
The study tests two experimental vaccines, BNT164a1 and BNT164b1, both designed as multi-antigen RNA vaccines for active immunization against tuberculosis. These vaccines are administered via intramuscular injection, with the goal of identifying a safe and effective dose.
The trial is a randomized, placebo-controlled, double-blind study with a sequential intervention model. Participants are randomly assigned to receive either the vaccine or a placebo, and the study is quadruple-masked, meaning neither the participants nor the care providers, investigators, or outcomes assessors know who receives which treatment. The primary purpose of the trial is prevention.
The study began on April 18, 2023, with the last update submitted on July 10, 2025. These dates are crucial as they mark the progression and ongoing status of the trial, indicating that results are still pending.
This clinical trial update could influence BioNTech’s stock performance and investor sentiment, as successful vaccine development could enhance the company’s position in the biopharmaceutical market. Investors may also consider the competitive landscape, as advancements in tuberculosis vaccines could impact other companies in the industry.
The study is currently ongoing, with further details available on the ClinicalTrials portal.