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

22 Pages Posted: 5 Mar 2019

See all articles by Zhenhua Ji

Zhenhua Ji

Kunming Medical University - Department of Microbiology and Immunology

Miaomiao Jian

Kunming Medical University - Department of Biochemistry and Molecular Biology

Taigui Chen

Kunming Medical University

Lisha Luo

Kunming Medical University

Xiting Dai

Kunming Medical University

Ruolan Bai

Kunming Medical University

Zhe Ding

Kunming Medical University

Yunfeng Bi

Kunming Medical University

Shiyuan Wen

Kunming Medical University

Guozhong Zhou

Kunming Medical University

Manzama-Esso Abi

Kunming Medical University

Aihua Liu

Kunming Medical University - Department of Biochemistry and Molecular Biology; Kunming Medical University - Yunnan Province Key Laboratory for Tropical Infectious Diseases in Universities; Kunming Medical University - The Institute for Tropical Medicine; Yunnan Demonstration Base of International Science and Technology Cooperation for Tropical Diseases

Fukai Bao

Kunming Medical University - Department of Microbiology and Immunology; Kunming Medical University - Yunnan Province Key Laboratory for Tropical Infectious Diseases in Universities; Kunming Medical University - The Institute for Tropical Medicine; Yunnan Demonstration Base of International Science and Technology Cooperation for Tropical Diseases

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Abstract

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.  

Findings: Seven eligible studies - involving 4,590 participants - were selected. The analysis revealed a vaccine immunogenicity of 58.90%, significantly higher abundance of M72-specific CD4+ T cells (standardized mean difference [SMD]=2.58) in the vaccine group versus the control group, the highest seropositivity rate (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).  

Interpretation: 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.

Funding: National Natural Science Foundation of China, Scientific and Technological Development Project of Yunnan Province of China.

Declaration of Interest: The authors declare no competing interests.

Keywords: vaccine; tuberculosis; M72/AS01E; immunogenicity; safety

Suggested Citation

Ji, Zhenhua and Jian, Miaomiao and Chen, Taigui and Luo, Lisha and Dai, Xiting and Bai, Ruolan and Ding, Zhe and Bi, Yunfeng and Wen, Shiyuan and Zhou, Guozhong and Abi, Manzama-Esso and Liu, Aihua and Bao, Fukai, Immunogenicity and Safety of the M72/AS01E Candidate Vaccine Against Tuberculosis: A Meta-Analysis (March 4, 2019). Available at SSRN: https://ssrn.com/abstract=3346517

Zhenhua Ji

Kunming Medical University - Department of Microbiology and Immunology

Kunming
China

Miaomiao Jian

Kunming Medical University - Department of Biochemistry and Molecular Biology

Kunming
China

Taigui Chen

Kunming Medical University

China

Lisha Luo

Kunming Medical University

China

Xiting Dai

Kunming Medical University

China

Ruolan Bai

Kunming Medical University

China

Zhe Ding

Kunming Medical University

China

Yunfeng Bi

Kunming Medical University

China

Shiyuan Wen

Kunming Medical University

China

Guozhong Zhou

Kunming Medical University

China

Manzama-Esso Abi

Kunming Medical University

China

Aihua Liu

Kunming Medical University - Department of Biochemistry and Molecular Biology ( email )

Kunming
China

Kunming Medical University - Yunnan Province Key Laboratory for Tropical Infectious Diseases in Universities ( email )

Kunming
China

Kunming Medical University - The Institute for Tropical Medicine ( email )

Kunming
China

Yunnan Demonstration Base of International Science and Technology Cooperation for Tropical Diseases ( email )

Kunming
China

Fukai Bao (Contact Author)

Kunming Medical University - Department of Microbiology and Immunology ( email )

Kunming
China

Kunming Medical University - Yunnan Province Key Laboratory for Tropical Infectious Diseases in Universities ( email )

Kunming
China

Kunming Medical University - The Institute for Tropical Medicine ( email )

Kunming
China

Yunnan Demonstration Base of International Science and Technology Cooperation for Tropical Diseases ( email )

Kunming
China

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