Immunogenicity and Safety of the M72/AS01E Candidate Vaccine Against Tuberculosis: A Meta-Analysis

Frontiers in Immunology

Ruolan Bai¹  Lisha Luo¹  Miaomiao Jian¹  Shiyuan Wen²  Guozhong Zhou²  Zhe Ding²  Lianbao Li²  Zhenhua Ji²  Manzama-Esso Abi²  Xiting Dai²  Yunfeng Bi²  Taigui Chen²  Fukai Bao⁴  Aihua Liu⁴ 

[1]Department of Biochemistry and Molecular Biology, Kunming Medical University, Kunming, China

[2]Department of Microbiology and Immunology, Kunming Medical University, Kunming, China

[3]The Institute for Tropical Medicine, Kunming Medical University, Kunming, China

[4]Yunnan Province Key Laboratory for Major Childhood Diseases, Kunming Medical University, Kunming, China

[5]Yunnan Province Key Laboratory for Tropical Infectious Diseases in Universities, Kunming Medical University, Kunming, China

关键词: vaccine;    tuberculosis;    M72/AS01E;    immunogenicity;    safety;   

DOI  :  10.3389/fimmu.2019.02089

来源: DOAJ

【 摘 要 】

Background: Currently, there is no tuberculosis (TB) vaccine recommended for use in latent TB infections and healthy adults. M72/AS01E is a new peptide vaccine currently under development, which may improve protection against TB disease. This vaccine has been investigated in several phase I/II clinical trials. We conducted a meta-analysis to clarify the immunogenicity and safety of the M72/AS01E peptide vaccine.Methods: We searched the PubMed, Embase, and Cochrane Library databases for published studies (until December 2018) investigating this candidate vaccine. A meta-analysis was performed using the standard methods and procedures established by the Cochrane Collaboration.Results: Seven eligible studies—involving 4,590 participants—were selected. The analysis revealed a vaccine efficacy was 57.0%, significantly higher abundance of polyfunctional M72-specific CD4+ T cells [standardized mean difference (SMD) = 2.58] in the vaccine group vs. the control group, the highest seropositivity rate [relative risk (RR) = 74.87] at 1 month after the second dose of vaccination (Day 60), and sustained elevated anti-M72 IgG geometric mean concentration at study end (Day 210) (SWD = 4.94). Compared with the control, participants who received vaccination were at increased risk of local injection site redness [relative risk (RR) = 5.99], local swelling (RR = 7.57), malaise (RR = 3.01), and fatigue (RR = 3.17). However, they were not at increased risk of headache (RR = 1.57), myalgia (RR = 0.97), and pain (RR = 3.02).Conclusion: The M72/AS01E vaccine against TB is safe and effective. Although the vaccine is associated with a mild adverse reaction, it is promising for the prevention of TB in healthy adults.

【 授权许可】

Unknown