Can a Recombinant BCG Vaccine Better Protect HIV-Positive Children?

Tuberculosis (TB) continues to be a significant public health problem worldwide, generally prevented in developing countries with the 100-year-old BCG vaccine. Yet, despite being a preventable and curable disease, 1.5 million people die from TB each year, making it the world's top infectious killer.

Over the years, immunization with the Mycobacterium bovis BCG vaccine has partially protected infants' lungs, reducing the incidence of miliary and tuberculosis meningitis.

However, the BCG vaccine is less effective against pulmonary TB.

A global team of researchers aimed to compare the safety and immunogenicity of Serum Institute of India (SSI) Pvt. Ltd.'s VPM1002 recombinant BCG vaccine candidate with BCG in HIV exposed and HIV unexposed newborn babies.

This study is essential since TB is the leading cause of death of people with HIV and also a major contributor to antimicrobial resistance, says the World Health Organization (WHO).

The results from the double-blind, randomized, active-controlled phase 2 study conducted at health centers in South Africa were published in the peer-review journal The Lancet Infectious Diseases on June 27, 2022.

Participants were randomly assigned to VPM1002 or BCG vaccination in a 3:1 ratio, stratified by HIV status. And the primary outcome was assessed in all vaccinated participants (safety population) at regular follow-up visits until 12 months after vaccination. 

These researchers concluded both vaccines were immunogenic in these children, although responses were higher with the old BCG vaccine.

But the VPM1002 vaccine was found less reactogenic than BCG and was not associated with any serious safety concerns.

The VPM1002 vaccine is a genetically modified BCG vaccine derived from the Mycobacterium Bovis BCG subtype Prague characterized as rBCGÄureC::Hly+. 

VPM1002 contains weakened tuberculosis-like bacteria, genetically modified, empowering immune cells to recognize the bacteria better.

SSI is currently funding a multicentric phase 3 clinical trial in babies in sub-Saharan Africa with VPM1002.

The WHO says about one-quarter of the world's population is estimated to be infected by TB.

About half of all people with TB can be found in just eight countries: Bangladesh, China, India, Indonesia, Nigeria, Pakistan, Philippines, and South Africa.

TB vaccination is not standard for children in the USA since most reported cases are travel-related.

As of June 28, 2022, the U.S. FDA had issued Organon Teknika Corp., LLC Approvals for two BCG vaccines: BCG Live and TICE BCG.

The WHO's Global Tuberculosis Report was last published on October 14, 2021.

Note: This study's findings were manually curated for mobile readership.