ArticleOpen forum infectious diseases2026
Safety of the M72/AS01 Tuberculosis Vaccine in People Living With HIV: A Systematic Review and Meta-Analysis.
Article in Open forum infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Tuberculosis (TB) remains a leading cause of morbidity and mortality among people living with HIV (PLHIV). Although M72/AS01 demonstrated efficacy against active TB in HIV-negative adults, its safety in PLHIV is uncertain. As AS01 induces strong innate immune activation, evaluating tolerability in immunocompromised individuals is essential. We assessed the safety of M72/AS01 in PLHIV receiving antiretroviral therapy (ART). Methods: We systematically searched MEDLINE, Embase, CENTRAL, and Web of Science for randomized controlled trials (RCTs) of PLHIV receiving M72/AS01 or placebo (last search 28 September 2025). Risk of bias was assessed using RoB 2 and certainty of evidence with GRADE. The protocol was registered in PROSPERO (CRD420251180412). Primary outcomes were risks of solicited local and systemic adverse events (AEs), any grade and grade 3, within 7 days postvaccination. Pooled risk ratios (RRs) were estimated using random-effects inverse-variance models. Results: Three RCTs (510 participants; M72/AS01 = 263, placebo = 247) were included. M72/AS01 increased risk of pain (RR 3.24, 95% CI 1.87-5.62), swelling (RR 4.64, 95% CI 2.93-7.34), headache (RR 1.83, 95% CI 1.52-2.20), myalgia (RR 2.36, 95% CI 1.80-3.10), and fever (RR 1.95, 95% CI 1.45-2.63). Events were predominantly mild-to-moderate and self-limited. No meaningful difference was observed in unsolicited AEs, and no vaccine-related serious AEs (SAEs) were reported. Certainty ranged from high (common events) to low (rare grade 3 AEs) due to imprecision. Conclusions: M72/AS01 demonstrated a favorable safety profile in immunologically stable, virologically suppressed adults living with HIV on ART, with no increase in SAE or unsolicited AEs. These findings support its safe use and justify future studies evaluating its efficacy for TB prevention in this population.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.