Health Editor’s Note: Tuberculosis (TB) is caused by the bacteria, Mycobacterium tuberculosis, and mostly affects the lungs but can also affect the kidneys, brain and spine. TB is curable and most importantly preventable. Someone with TB can have a hidden (latent) form of the disease and although he or she shows no symptoms can spread the disease through the air by coughing, sneezing, and/or spitting. It only take a few of these bacteria to be inhaled for someone to become infected. About one fourth of the world’s population has latent TB. This is scary since you could be standing or sitting next to someone in a line, on a bus, subway, in an airport, etc. and be infected.
According to WHO these are some statistics on who may be affected:
- Tuberculosis (TB) is one of the top 10 causes of death worldwide.
- In 2017, 10 million people fell ill with TB, and 1.6 million died from the disease (including 0.3 million among people with HIV).
- In 2017, an estimated 1 million children became ill with TB and 230 000 children died of TB (including children with HIV associated TB).
- TB is a leading killer of HIV-positive people.
- Multidrug-resistant TB (MDR-TB) remains a public health crisis and a health security threat. WHO estimates that there were 558 000 new cases with resistance to rifampicin – the most effective first-line drug, of which – 82% had MDR-TB.
- Globally, TB incidence is falling at about 2% per year. This needs to accelerate to a 4–5% annual decline to reach the 2020 milestones of the End TB Strategy.
- An estimated 54 million lives were saved through TB diagnosis and treatment between 2000 and 2017.
- Ending the TB epidemic by 2030 is among the health targets of the Sustainable Development Goals.
Finding a way to furnish the TB vaccine to areas of the world that are hard to access and areas which do not have widespread refrigeration will be a great help in protecting all people…..Carol
Temperature-Stable Experimental Tuberculosis Vaccine Enters Clinical Testing
By National Institutes of Health
Vaccinations have begun in a Phase 1 human clinical trial testing a freeze-dried, temperature-stable formulation of an experimental tuberculosis (TB) vaccine candidate. The trial is being conducted at the Saint Louis University School of Medicine Center for Vaccine Development and will enroll as many as 48 healthy adult volunteers aged 18 to 55 years. The experimental vaccine, called ID93, was developed by scientists at the Infectious Disease Research Institute (IDRI) in Seattle. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is supporting the trial through a contract to IDRI.
ID93 is a recombinant vaccine candidate made from four proteins of Mycobacterium tuberculosis (the bacterium that causes TB). Many vaccines require a temperature-controlled system during transport, which can be costly and logistically challenging. Freeze-dried powder vaccines can be distributed at a cheaper cost to remote, low-resource settings. The powder formulations are mixed with sterile water for administering with a needle and syringe. Investigators are examining if a powder formulation combining ID93 and the adjuvant GLA-SE (an immune response-stimulating protein) in a single vial, reconstituted with sterile water, is as effective at inducing an immune response in participants as the previously tested two-vial combination of powdered ID93 and liquid GLA-SE.
“Tuberculosis remains the leading infectious cause of death worldwide, and a highly effective vaccine would be a crucial tool in ending this pandemic,” said NIAID Director Anthony S. Fauci, M.D. “A vaccine that did not require a cold chain could be much more easily distributed to communities in need.”
Currently, Bacillus Calmette–Guérin (BCG) is the only Food and Drug Administration approved TB vaccine. It is commonly given to babies in TB-endemic regions to protect children against meningitis and disseminated disease. However, the vaccine does not adequately prevent TB disease in adolescents and adults.
ID93 + GLA-SE is being developed as a vaccine candidate that could be administered to people who have already received the BCG vaccine or have already been exposed to TB, to prevent reactivation or reinfection. The vaccine was recently shown to be safe and immunogenic in a Phase 2a clinical trial that enrolled adults in South Africa who had recently been cured of TB with standard therapy. Other early-stage clinical trials showed ID93 + GLA-SE is safe and immunogenic in healthy adults in the United States and in BCG-vaccinated adults in South Africa.
“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, Ph.D., 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.”
Daniel Hoft, M.D., Ph.D., director of the Division of Infectious Diseases, Allergy and Immunology at the Saint Louis University School of Medicine, is the principal investigator for the clinical trial. All participants will receive two vaccinations 56 days apart. Half of those enrolled (24 people) will receive the single-vial formulation of ID93 and GLA-SE, and the remaining participants will receive the previously tested two-vial presentation of powdered ID93 and liquid GLA-SE.
Participants will be monitored for any possible reactions to the vaccine and will be asked to provide blood samples at specified time points over approximately seven months. Investigators will examine the samples to determine if participants have generated an immune response. To ensure the safety of participants, a safety monitoring committee composed of an independent group of experts will review safety data throughout the trial, which is expected to end in November 2020. For more information, visit ClinicalTrials.gov and search identifier NCT03722472.
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.