Open forum infectious diseases · 2025
Safety of Bacillus Calmette-Guérin Vaccination and Impact on HIV-1 Latent Reservoir Size in People With Treated HIV-1 Infection.
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West Emily, Chaudron Sandra E, Russenberger Doris, Grube Christina, Metzner Karin J, Neumann Kathrin, Tschumi Jasmin, Kälin Marisa, Tutumlu Terence K, Dollé Cédric, Kouyos Roger D, Günthard Huldrych F, Braun Dominique L, Nemeth Johannes
Аннотация
BACKGROUND: Bacillus Calmette-Guérin (BCG) vaccination, used against tuberculosis, is recognized for its immunomodulatory properties, a phenomenon referred to as "trained immunity." Given these effects, there is increasing interest in evaluating its safety and impact on immune function in people living with HIV-1 (PWH). Historically, BCG was contraindicated in PWH due to safety concerns in immunocompromised individuals. This study aims to assess both the safety of BCG in PWH and its effects on the HIV-1 latent reservoir size.
METHODS: This Phase IIA randomized, double-blind, placebo-controlled, single-center trial enrolled 60 PWH with a suppressed viral load and CD4 T-cell count >350/μL. Participants were randomized in a stepped-wedge design into equal groups for early or late BCG vaccination. Each participant received a single intradermal dose of BCG vaccine followed by a placebo 3 months later, or vice versa. The HIV-1 latent reservoir was quantified at 3-month intervals to day 270. The primary endpoint was the HIV-1 reservoir size 6 months postvaccination, with secondary endpoints including safety outcomes.
RESULTS: No significant differences were found in intact proviral HIV-1 DNA levels at 6 months compared to baseline. Local reactions occurred in 96% of participants, leading to scarring in 73%. No systemic infections or serious BCG-related adverse events were observed.
CONCLUSIONS: BCG vaccination is safe in PWH, but local skin reactions including scarring are common. There was no significant effect on the HIV-1 reservoir. These findings provide valuable insights into the safety profile of BCG vaccination in PWH, emphasizing its potential for broader immunological studies.
METHODS: This Phase IIA randomized, double-blind, placebo-controlled, single-center trial enrolled 60 PWH with a suppressed viral load and CD4 T-cell count >350/μL. Participants were randomized in a stepped-wedge design into equal groups for early or late BCG vaccination. Each participant received a single intradermal dose of BCG vaccine followed by a placebo 3 months later, or vice versa. The HIV-1 latent reservoir was quantified at 3-month intervals to day 270. The primary endpoint was the HIV-1 reservoir size 6 months postvaccination, with secondary endpoints including safety outcomes.
RESULTS: No significant differences were found in intact proviral HIV-1 DNA levels at 6 months compared to baseline. Local reactions occurred in 96% of participants, leading to scarring in 73%. No systemic infections or serious BCG-related adverse events were observed.
CONCLUSIONS: BCG vaccination is safe in PWH, but local skin reactions including scarring are common. There was no significant effect on the HIV-1 reservoir. These findings provide valuable insights into the safety profile of BCG vaccination in PWH, emphasizing its potential for broader immunological studies.