VPM1002 missed non-inferiority to BCG in 6,940 newborns

QFT conversion was 5.3% with VPM1002 and 4.3% with BCG. Only 334 of 632 planned events accrued, leaving infant TB disease protection unresolved.

THE HOT TAKE

VPM1002 did not clear the trial’s non-inferiority bar. Sparse infection events and a surrogate endpoint make this a setback, not a complete verdict on infant tuberculosis protection.

A phase 3 trial enrolled 6,950 healthy newborns across five sub-Saharan African countries. After ten withdrawals, 6,940 infants aged 0–14 days and weighing at least 2.3 kg were randomly assigned to a single intradermal dose of VPM1002 or BCG. The question was whether the recombinant candidate could preserve BCG-level protection against incident Mycobacterium tuberculosis infection.

THE PRIMARY RESULT