Mycobacterium vaccae vaccine to prevent tuberculosis in high risk people: A meta-analysis

Yang, Xiao-yan; Chen, Qun-fei; Cui, Xiao-hua; Yu, Yu; Li, You-ping

doi:10.1016/j.jinf.2010.02.005

« Previous Next »Journal of Infection
Volume 60, Issue 5 , Pages 320-330, May 2010

Mycobacterium vaccae vaccine to prevent tuberculosis in high risk people: A meta-analysis

Xiao-yan Yang
- Chinese Evidence-Based Medicine Center/The Chinese Cochrane Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
Qun-fei Chen
- Chinese Evidence-Based Medicine Center/The Chinese Cochrane Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
Xiao-hua Cui
- Chinese Evidence-Based Medicine Center/The Chinese Cochrane Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
Yu Yu
- West China Medical School, Sichuan University, Chengdu 610041, Sichuan Province, China
You-ping Li
- Chinese Evidence-Based Medicine Center/The Chinese Cochrane Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
- Corresponding author. Tel.: +86 28 85423040; fax: +86 28 85422253.

Accepted 6 February 2010. published online 04 March 2010.

Summary

Objective

To evaluate the effectiveness and safety of Mycobacterium vaccae (MV) in prevention of tuberculosis (TB) among high risk people.

Methods

Database of MEDLINE, EMBASE, BIOSIS, SCI, Cochrane Central Register of Controlled Trials, CBM, CNKI and VIP were searched till July 2009. Randomized controlled trials (RCTs) or non-randomized controlled clinical trials (CCTs) investigating MV as interventions in people at high risk of TB were identified for critical appraisal. Two reviewers independently performed data extraction and quality assessment. Effectiveness of MV was summarized in different group of risk people through RevMan 5.0 by The Cochrane Collaboration.

Results

Thirteen studies were included. Risk difference (RD) of protection index (PI), its 95% confidence interval (95%CI) and the P value were as following: MV vs. Isoniazid (INH): 0.02 (−0.01, 0.05) (P=0.12); MV vs. (INH plus RFT): 0.00 (−0.00, 0.00) (P=1.00); MV vs. Blank: 0.04 (0.00, 0.08) (P=0.03) for soldiers with PPD strong positive; 0.00 (−0.00, 0.00) (P=0.05) for students with PPD strong positive; 0.20 (0.05, 0.36) (P=0.01) for aged people of clinical cured pulmonary TB, and 0.08 (0.01, 0.14) (P=0.03) for type 2 diabetes mellitus. In HIV-infected people, The Risk Ratio (RR) of MV vs. CV (control vaccine) of positive stimulation index (SI) (≥3) in lymphocyte proliferation assays (LPA) to Mycobacterium vaccae sonicate (MVS) was 2.39 with 95% CI (1.56, 3.66), P<0.0001. Immunization had no adverse effects on CD4 cell count or HIV viral load. The most frequent adverse effects of MV were induration and sore arm.

Conclusions

Available evidence shows that MV is effective in preventing TB in PPD strong positive/type 2 diabetes mellitus/aged people of clinical cured pulmonary TB, and is safe, well-tolerated and effective in inducing biologically relevant immune response against TB in HIV-infected patients. High-quality trials aimed at different groups of high risk people are encouraged.

Keywords: Mycobacterium vaccae, Tuberculosis, Purified protein derivative (PPD), HIV infection, Meta-analysis