New hope for TB prevention in people with HIV as experimental vaccine deemed safe

THE experimental M72/AS01 tuberculosis (TB) vaccine has shown a favourable safety profile in people living with HIV who are on antiretroviral therapy (ART), boosting prospects for TB prevention in one of the most vulnerable groups.

According to findings published in Open Forum Infectious Diseases and shared on The Choice Agenda, a systematic review of three randomized controlled trials in South Africa, India and Switzerland found the vaccine was well tolerated over short-term follow-up, despite higher rates of mild to moderate side effects.

The analysis included 510 participants, 263 who received M72/AS01 and 247 who received placebo, all immunologically stable and virally suppressed with median CD4 counts above 600.

Like most vaccines, M72 triggered more short-term reactions: Any-grade injection site pain was three times more common, while swelling was over four times more common. Systemic reactions such as headache, fatigue, myalgia and fever were also higher, but mostly mild. Severe grade 3 events were rare, and no severe adverse event was linked to the vaccine.

Importantly, unsolicited adverse events were similar between vaccine and placebo groups, suggesting no hidden safety signal.

People with HIV remain at high risk of TB even on ART, yet safety data for M72/AS01 in this population has been scarce. The researchers say the current evidence supports its tolerability in stable, suppressed adults, but note it may not apply to children, untreated people, or those with advanced immunosuppression.

The finding is significant as the world searches for an effective TB vaccine. If proven effective, M72/AS01 could help cut TB illness and deaths among people living with HIV.

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