Understanding the Mechanisms of Intravenous BCG-Induced Protection Against Tuberculosis in Nonhuman Primates (TB Vaccine)

The Problem
Only one vaccine (the BCG vaccine) protects infants against tuberculosis (TB) – the deadliest infection in the world – but when injected underneath infants’ skin, this vaccine yields inconsistent results.
The Solution
The TB Vaccine Project will determine whether intravenous delivery of the BCG vaccine is more consistently effective at protecting infants against TB infection than is intradermal delivery.


According to the World Health Organization (WHO), tuberculosis (TB) is the ninth leading cause of death worldwide and the primary cause from a single infectious agent, ranking above HIV/AIDS. Approximately 10.4 million people fell ill with TB in 2016, with an increase in new cases compared to the previous year. The need for an effective TB vaccine is urgent.

The Bacillus Calmette-Guérin (BCG) vaccine is the only vaccine currently approved for use in infants to prevent TB. However, when delivered intradermally (injected into the skin), the BCG vaccine has variable results. Through a new project called Understanding the Mechanisms of Intravenous BCG-Induced Protection Against TB in Nonhuman Primates (TB Vaccine), Researchers are exploring alternative, more effective methods to deliver the vaccine to patients. Funded through a grant from the Bill & Melinda Gates Foundation to FNIH, the TB Vaccine project will be conducted jointly by the National Institute of Allergy and Infectious Diseases (NIAID) and the University of Pittsburgh.

TB Vaccine Researchers will study the effects of using a new intravenous (IV) delivery method for the BCG vaccine to treat TB. This method may better activate T cells (white blood cells) that help trigger an important, long-term immune response in the lungs to prevent TB. The Researchers will test this method of delivery in macaques over nine months and will then analyze the results through blood tests, image scans and autopsies.


Public-Sector Partners

  • National Institute of Allergy and Infectious Diseases (NIAID)

Private-Sector Partners

  • Bill & Melinda Gates Foundation*

Academic Partners

  • University of Pittsburgh

*Provided financial or in-kind support for this program.

FNIH Contact

  • Michael Santos, Ph.D., Senior Vice President, Chief Population Health Science Officer [email protected]


  • Define an immune correlate threshold of protection.
  • Identify immune mechanisms of protection.
  • Determine the role of humoral immunity in mediating protection.


FNIH Announcement (March 19, 2019): FNIH Launches New Project to Improve Vaccination Against Tuberculosis Read more

NY Times – New Injection Method Makes an Old TB Vaccine Far More Powerful Read more

Nature – Tuberculosis vaccine finds an improved route Read more

STAT – Delivering the TB vaccine by IV better protects monkeys, new study finds Read more

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