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Rachel V Thomas

New TB Vaccine Falls Short Of BCG In Newborns, Phase 3 Trial Shows

A Phase 3 trial of the new tuberculosis (TB) vaccine candidate VPM1002, sponsored by Pune-based Serum Institute of India, has fallen short of showing that it is as effective as the over 100-year-old BCG vaccine at preventing TB infection in newborns, according to results published in The Lancet Infectious Diseases.

VPM1002 is a live recombinant vaccine created by genetically modifying BCG. It was originally developed in Germany and licensed to the Serum Institute of India.

The trial compared VPM1002 with BCG in newborns across Kenya, Tanzania, Uganda, South Africa and Gabon.

<ul><li>VPM1002 did not meet the criteria for non-inferiority compared with BCG.</li><li>After a median follow-up of 35 months, QFT conversion (an indicator of TB infection) occurred in 5.3% of infants given VPM1002 versus 4.3% given BCG. </li><li>VPM1002 also failed to meet non-inferiority criteria for other endpoints, including microbiologically confirmed TB.</li><li>No vaccine-related serious adverse events were reported. </li></ul>

“The results favored BCG over VPM1002 across the efficacy endpoints,” said the research team, which included Videlis Nduba of the Kenya Medical Research Institute and Center for Respiratory Disease Research.

The VPM1002 group had more QFT conversions (184 vs 150), confirmed TB cases (18 vs six), unconfirmed TB cases (92 vs 53) and sustained QFT conversions (44 vs 33), researchers said.

The trial included healthy newborns aged 0–14 days weighing at least 2.3 kg.

<ul><li>6,940 newborns were randomized; 6,897 received vaccination.</li><li>Of those randomized, 720 were born to mothers living with HIV, while 6,220 were HIV-unexposed.</li><li>The trial ran from November 2020 to June 2022.</li></ul>

The trial recorded only 334 of the 632 planned TB infection events. Researchers also noted that TB blood-test results did not always match confirmed TB infections, while more infants in the VPM1002 group had household TB exposure.

“In this paper, what the researchers have measured is developing ‘TB infection’ after vaccination. This does not mean that all babies had TB disease,” said Dr Swathi Krishna, a TB researcher in Maharashtra who was not part of the study.

“A slightly higher number of babies in the VPM group developed infection as compared to the BCG group. This does not explicitly mean that VPM is inferior to BCG, but it falls short of proving its ability in this particular study,” she told HealthandMe.

BCG, introduced in 1921, remains the only licensed TB vaccine. While it protects children against severe TB, its effectiveness against pulmonary TB in adolescents and adults varies.

VPM1002 is one of 17 TB vaccine candidates in development. TB affected an estimated 10.7 million people and killed 1.2 million globally in 2024.

“There is an urgent need for new tuberculosis vaccines” that are effective across age groups and can be produced at scale, the researchers wrote.

Helen McShane, professor of vaccinology at the University of Oxford, said the findings show that “there are no obvious shortcuts in tuberculosis vaccine efficacy trials.”

<h2>Previous Study Of VPM1002 And Immuvac</h2>

A Phase 3 trial published in The British Medical Journal in April found:

<ul><li>Both vaccines could be safe for adults and children in India.</li><li>Neither provided general protection against TB or prevented latent TB infection.</li><li>Both showed an ability to prevent progression to active TB among those who developed latent TB.</li><li>VPM1002 showed 50.4% effectiveness against extrapulmonary TB across all age groups.</li></ul>

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A Phase 3 trial of the new tuberculosis (TB) vaccine candidate VPM1002, sponsored by Pune-based Serum Institute of India, has fallen short of showing that it is as effective as the over 100-year-old BCG vaccine at preventing TB infection in newborns, according to results published in The Lancet Infectious Diseases.VPM1002 is a live recombinant vaccine created by genetically modifying BCG. It was originally developed in Germany and licensed to the Serum Institute of India.The trial compared VPM1002 with BCG in newborns across Kenya, Tanzania, Uganda, South Africa and Gabon.What Did The Trial Find?VPM1002 did not meet the criteria for non-inferiority compared with BCG.After a median follow-up of 35 months, QFT conversion (an indicator of TB infection) occurred in 5.3% of infants given VPM1002 versus 4.3% given BCG. VPM1002 also failed to meet non-inferiority criteria for other endpoints, including microbiologically confirmed TB.No vaccine-related serious adverse events were reported. “The results favored BCG over VPM1002 across the efficacy endpoints,” said the research team, which included Videlis Nduba of the Kenya Medical Research Institute and Center for Respiratory Disease Research.The VPM1002 group had more QFT conversions (184 vs 150), confirmed TB cases (18 vs six), unconfirmed TB cases (92 vs 53) and sustained QFT conversions (44 vs 33), researchers said.How Was The Study Conducted?The trial included healthy newborns aged 0–14 days weighing at least 2.3 kg.6,940 newborns were randomized; 6,897 received vaccination.Of those randomized, 720 were born to mothers living with HIV, while 6,220 were HIV-unexposed.The trial ran from November 2020 to June 2022.Trial LimitationsThe trial recorded only 334 of the 632 planned TB infection events. Researchers also noted that TB blood-test results did not always match confirmed TB infections, while more infants in the VPM1002 group had household TB exposure.“In this paper, what the researchers have measured is developing ‘TB infection’ after vaccination. This does not mean that all babies had TB disease,” said Dr Swathi Krishna, a TB researcher in Maharashtra who was not part of the study.“A slightly higher number of babies in the VPM group developed infection as compared to the BCG group. This does not explicitly mean that VPM is inferior to BCG, but it falls short of proving its ability in this particular study,” she told HealthandMe.Why New TB Vaccines Are NeededBCG, introduced in 1921, remains the only licensed TB vaccine. While it protects children against severe TB, its effectiveness against pulmonary TB in adolescents and adults varies.VPM1002 is one of 17 TB vaccine candidates in development. TB affected an estimated 10.7 million people and killed 1.2 million globally in 2024.“There is an urgent need for new tuberculosis vaccines” that are effective across age groups and can be produced at scale, the researchers wrote.Helen McShane, professor of vaccinology at the University of Oxford, said the findings show that “there are no obvious shortcuts in tuberculosis vaccine efficacy trials.”Previous Study Of VPM1002 And ImmuvacA Phase 3 trial published in The British Medical Journal in April found:Both vaccines could be safe for adults and children in India.Neither provided general protection against TB or prevented latent TB infection.Both showed an ability to prevent progression to active TB among those who developed latent TB.VPM1002 showed 50.4% effectiveness against extrapulmonary TB across all age groups.

new tb vaccine falls short of bcg in newborns, phase 3 trial shows

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