Clinical trial starts for temperature-stable tuberculosis vaccine

The small trial is meant to test the efficacy of a powdered form of a combination vaccine for TB that can be freeze-dried for shipping to locations without refrigeration.

By Tauren Dyson

Jan. 23 (UPI) -- Researchers have started conducting trials with an experimental tuberculosis vaccine candidate that can survive without refrigeration, the National Institutes of Health said.

The ID93 + GLA-SE is a vaccine candidate to be administered to stop reactivation or reinfection of TB in patients who have already taken the BCG vaccine or who currently have the disease, say researchers testing it.


During a Phase 2a clinical trial, ID93 + GLA-SE was proven to be safe and immunogenic in South African adults who already took the standard therapy to cure their TB.

The recombinant ID93 vaccine candidate consists of four proteins of Mycobacterium tuberculosis, which causes TB. Other vaccines need to travel in costly temperature-controlled systems. The freeze-dried powder vaccine candidate can be transported more cheaply to poorer countries, researchers say.

For the trial, the researchers are testing a combination of ID93 and GLA-SE, an adjuvant immune response-stimulating protein.

The new vaccine candidate has also shown promise in early-stage trials within the United States.

"Tuberculosis remains the leading infectious cause of death worldwide, and a highly effective vaccine would be a crucial tool in ending this pandemic," Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a news release. "A vaccine that did not require a cold chain could be much more easily distributed to communities in need."


To date, Bacillus Calmette-Guérin is the only TB vaccine approved by the Food and Drug Administration, and is normally given to infants to prevent "meningitis and disseminated disease." But it doesn't adequately keep children and adults from developing the disease.

Globally, the World Health Organization reports that about 1.8 billion people have been infected with Mycobacterium tuberculosis, which causes TB. Last year, 1.6 million people worldwide died from the disease.

The Centers for Diseases Control and Prevention says more than 70 percent of TB cases in the U.S. people not born in the country.

To combat the global problem of TB, the United Nations and CDC met with over 1,000 heads of state, health officials, non-profit organizations and survivors from nations around the world to draft the "Political Declaration on TB."

"To our knowledge, the freeze-dried formulation of ID93 + GLA-SE represents the first time a thermostable vaccine candidate containing a modern immune-boosting substance has reached clinical testing," said Christopher Fox, vice president of Formulations at IDRI and principal investigator of the NIAID contract. "Implementing technologies designed for low-resource settings early in product development could help accelerate vaccine rollout in hard-to-reach areas."

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