Dagnew, A.F., et al. Safety and immunogenicity of investigational tuberculosis vaccine M72/AS01E4 in people living with HIV in South Africa: an observer-blinded, randomised, controlled, phase 2 trial. Lancet HIV, 2025 Aug, 12(8):e546-e555.

Dagnew, A.F., et al. Safety and immunogenicity of investigational tuberculosis vaccine M72/AS01E4 in people living with HIV in South Africa: an observer-blinded, randomised, controlled, phase 2 trial. Lancet HIV, 2025 Aug, 12(8):e546-e555. PMID: 40614747

• The study evaluated the safety, reactogenicity, and immunogenicity of two doses of the TB vaccine M72/AS01 E–4 in over 400 HIV-positive adults in South Africa with well-controlled, virally suppressed HIV. 
• The vaccine was well tolerated, with mostly mild or moderate side effects such as injection-site pain, headache, and fatigue, and showed no serious adverse events related to vaccination. Importantly, it elicited strong antibody and T-cell responses, indicating a robust immune response, which was sustained through the end of the trial. 
• The paper describes QS-21 as a key component of the AS01 E–4 adjuvant system used in the M72/AS01 E–4 tuberculosis vaccine. QS-21 is a saponin extract derived from Quillaja saponaria Molina, included at a dose of 25 μg per vaccine dose. The study reports that the vaccine, which contains QS-21, elicited robust antibody and CD4 T-cell responses, indicating that QS-21 contributes significantly to the vaccine’s immunogenic profile. Additionally, the safety data suggest that inclusion of QS-21 does not compromise tolerability, as most adverse events were mild or moderate and transient. 
• These findings support further testing of the vaccine in larger populations, including people living with HIV, to assess its effectiveness in preventing tuberculosis in this high-risk group.

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