Clinical trials of the experimental stable temperature antituberculous vaccine begin

Vaccines were initiated in a human phase 1 clinical trial with a lyophilized, temperature-stable formulation of an experimental TB vaccine candidate. The trial is underway at the Vaccine Development Center of the University of St. Louis School of Medicine and will recruit up to 48 healthy adult volunteers aged 18 to 55 years. The experimental vaccine, called ID93, was developed by scientists at Seattle's Institute for Infectious Disease Research (IDRI). The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, supports the trial under a contract with IDRI.

ID93 is a recombinant vaccine candidate based on four Mycobacterium tuberculosis (the bacterium that causes tuberculosis). Many vaccines require a temperature-controlled system during transport, which can be expensive and logistically difficult. Lyophilized powdered vaccines can be cheaply distributed in remote areas with few resources. The powdered formulations are mixed with sterile water to be administered with a needle and a syringe. Researchers are investigating whether a powdered formulation combining ID93 and adjuvant GLA-SE (immune stimulating protein) in a single vial reconstituted with sterile water is also effective in inducing an immune response in participants that the two-bottle test previously tested. combination of ID93 powder and GLA-SE liquid.

"Tuberculosis remains the leading infectious cause of death in the world and a highly effective vaccine would be an essential tool to end this pandemic," said Anthony S. Fauci, director of NIAID, "A vaccine that does not require a chain cold could be much more effective "easily distributed to communities in need".

Bacillus Calmette-Guerin (BCG) is currently the only TB vaccine approved by the Food and Drug Administration. It is usually given to babies in areas where TB is endemic to protect children from meningitis and disseminated disease. However, the vaccine does not adequately prevent tuberculosis in adolescents and adults.

ID93 + GLA-SE is currently being developed as a vaccine candidate that can be administered to people who have already received BCG vaccine or have been exposed to TB, to prevent their reactivation or reinfection. The vaccine has recently been shown to be safe and immunogenic in a Phase 2a clinical trial involving South African adults recently cured of tuberculosis through standard therapy. Other early stage clinical trials have shown that ID93 + GLA-SE is safe and immunogenic in healthy adults in the United States and in adults vaccinated with BCG in South Africa.

"To our knowledge, the freeze-dried formulation of ID93 + GLA-SE represents the first time that a heat-stable vaccine test containing a modern immunostimulatory substance achieved clinical testing," said Christopher Fox, Ph.D. , Vice President of Formulations. at IDRI and NIAID contract principal investigator. "Implementing technologies designed for low-resource environments early in product development could help accelerate vaccine deployment in hard-to-reach areas."

Daniel Hoft, MD, Ph.D., director of the Division of Infectious Diseases, Allergies and Immunology at the Faculty of Medicine at St. Louis University, is the principal investigator of clinical trial. All participants will receive two vaccines 56 days apart. Half of the registrants (24 people) will receive the one-bottle formulation of ID93 and GLA-SE, and the remaining participants will receive the previously tested two-bottle presentation of ID93 powder and liquid GLA-SE.

Participants will be monitored for possible reactions to the vaccine and will be asked to provide blood samples at specific times over a period of approximately seven months. Investigators will examine the samples to determine if the participants generated an immune response. To ensure participant safety, a safety oversight committee composed of an independent expert panel will review the safety data throughout the test, which is expected to be completed by November 2020. For more information, visit ClinicalTrials.gov and look for the NCT03722472 identifier.