New tuberculosis (TB) vaccine that does not require refrigeration elicits better immune responses
A clinical trial testing a lyophilized, temperature-stable experimental tuberculosis (TB) vaccine in healthy adults found it to be safe and to stimulate both antibodies and responses from the cellular arm of the immune system.
The Phase 1 trial was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Candidate non-temperature-stable forms had previously been tested in several clinical trials. However, this was the first clinical trial of a temperature-stable (thermostable) form of the subunit TB vaccine candidate. The results are published in Nature Communications.
The experimental vaccine ID93+GLA-SE was developed by Dr. Christopher B. Fox and scientists at the Access to Advanced Health Institute (formerly the Infectious Disease Research Institute) in Seattle. This is a recombinant subunit vaccine made from four proteins of Mycobacterium tuberculosis combined with the immunostimulatory adjuvant GLA-SE. Freeze-dried formulations do not require refrigeration and are mixed with sterile water just prior to injection. Thermostable vaccines are desirable when cold or frozen vaccines are expensive and difficult to maintain for extended periods of time.
In the current study, administration of a single vial of temperature-stable vaccine containing both ID93 and GLA-SE compared to two vials of non-thermostable ID93 and liquid GLA-SE to induce an immune response. and combine before injection. Researchers note that the single-vial presentation of thermostable vaccines has clear advantages in terms of ease of storage, transportation, and administration.
Daniel F. Hoft, MD, Ph.D., Director of the Center for Vaccine Development at St. Louis University, led the single-center trial at the University of St. Louis School of Medicine. Twenty-three participants received the thermostable single vial his regimen and 22 participants received his two vial non-thermostable his regimen. Both vaccine presentations were safe and well tolerated. Recipients of the single-vial thermostable vaccine showed robust her T-cell responses and had higher antibody levels in blood than those who received the non-thermostable two-vial presentation.
The researchers note that this small trial has some limitations. For example, there are no established protective correlations that define the immune responses required for vaccine-induced protection from tuberculosis disease. Therefore, it cannot be said whether the enhanced immune response seen with thermostable vaccine formulations translates into improved efficacy of protective vaccines. Nonetheless, they said, the results of this trial support the concept that “an adjuvant-containing vaccine can be formulated in a lyophilized, single-vial presentation without adversely affecting clinical immunogenicity or safety characteristics.” It concludes that it shows “demonstration”.
Original: Thermostable tuberculosis vaccine is safe and boosts immune response in NIH-supported study
Than: National Institutes of Health | St. Louis University
