Abstract:

Objective: To investigate the effects of Mycobacterium vaccinae on T Lymphocyte subsets in HIV patients complicated with latent tuberculosis infection (LTBI) and its safety. Methods: Using a multicenter prospective cohort study method, 96 HIV patients complicated with LTBI who were confirmed through tuberculin skin test screening and managed by the AIDS management agency in Yinchuan City, Ningxia Hui Autonomous Region from June 2003 to June 2020 were continuously included as the study subjects. The research subjects were divided into experimental group (n=63) and control group (n=33) according to the counties and districts. Based on efficient antiretroviral therapy, the experimental group was injected with Mycobacterium vaccinae (22.5 μg, once every two weeks for three times), and the control group received oral isoniazid (300 mg, once a day, continuously for 6 months). Levels of immune cells such as CD4⁺, CD8⁺, and CD3⁺T cells, as well as changes in liver function indicators between the two groups were measured and compared before treatment and at 1-month and 3-month follow-up after treatment. In addition, the occurrence of adverse reactions in both groups was evaluated. Results: One month after the end of treatment, the level of CD3⁺T cells in the experimental group was (1583.83±584.69) cells/μl, significantly higher than that before treatment ((1221.20±399.52) cells/μl; t=-2.962, P=0.004). Three months after the end of treatment, the levels of CD3⁺, CD4⁺, and CD8⁺T cells were (1816.67±736.86) cells/μl, (674.10±282.30) cells/μl and (833.21±314.11) cells/μl, significantly higher than those before treatment ((1221.20±399.52) cells/μl, t=-4.460, P<0.001; (588.71±273.44) cells/μl, t=-2.801, P=0.044; and (609.65±267.71) cells/μl, t=-3.801, P<0.001, respectively). Three months after the end of treatment, the levels of CD3⁺, CD4⁺T cells, and CD4⁺/CD8⁺ ratio (0.86±0.54) in the experimental group were significantly higher than those in the control group ((1716.47±689.07) cells/μl, t=2.209, P=0.034; (559.11±187.14) cells/μl, t=3.666, P=0.008; 0.82±0.74, t=3.502, P=0.001, respectively). One month after the end of treatment, the level of aspartate aminotransferase in the control group was (33.15±11.70) U/L, significantly higher than that in the experimental group ((26.54±9.63) U/L, t=2.624, P=0.011). Three months after the end of treatment, the levels of alanine aminotransferase ((52.58±27.72) U/L) and alanine aminotransferase ((33.74±11.89) U/L) in the control group were significantly higher than those in the experimental group ((35.29±21.16) U/L, t=2.563, P=0.013; and (26.67±11.07) U/L, t=2.172, P=0.034, respectively). The experimental group had no adverse reactions and no patients withdrew from treatment, with a treatment completion rate of 100.0% (63/63), significantly higher than that of the control group (84.9% (28/33), χ²=7.235, P=0.007). Conclusion: The use of Mycobacterium vaccinae for anti-tuberculosis prophylactic treatment in HIV patients complicated with LTBI can improve the cellular immune levels and cause less damage to liver function, indicating good safety.

Key words: Mycobacterium tuberculosis, Tuberculosis vaccines, T-lymphocyte subsets, HIV infections, Prospective studies