Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial
Seroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Our aim was to assess efficacy and safety of a recombinant hepatitis E vaccine, HEV 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China) in a randomised, double-blind, placebo-contro...
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| Published in | The Lancet (British edition) Vol. 376; no. 9744; pp. 895 - 902 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Kidlington
Elsevier Ltd
11.09.2010
Elsevier Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Seroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Our aim was to assess efficacy and safety of a recombinant hepatitis E vaccine, HEV 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China) in a randomised, double-blind, placebo-controlled, phase 3 trial.
Healthy adults aged 16–65 years in, Jiangsu Province, China were randomly assigned in a 1:1 ratio to receive three doses of HEV 239 (30 μg of purified recombinant hepatitis E antigen adsorbed to 0·8 mg aluminium hydroxide suspended in 0·5 mL buffered saline) or placebo (hepatitis B vaccine) given intramuscularly at 0, 1, and 6 months. Randomisation was done by computer-generated permuted blocks and stratified by age and sex. Participants were followed up for 19 months. The primary endpoint was prevention of hepatitis E during 12 months from the 31st day after the third dose. Analysis was based on participants who received all three doses per protocol. Study participants, care givers, and investigators were all masked to group and vaccine assignments. This trial is registered with
ClinicalTrials.gov, number
NCT01014845.
11 165 of the trial participants were tested for hepatitis E virus IgG, of which 5285 (47%) were seropositive for hepatitis E virus. Participants were randomly assigned to vaccine (n=56 302) or placebo (n=56 302). 48 693 (86%) participants in the vaccine group and 48 663 participants (86%) in the placebo group received three vaccine doses and were included in the primary efficacy analysis. During the 12 months after 30 days from receipt of the third dose 15 per-protocol participants in the placebo group developed hepatitis E compared with none in the vaccine group. Vaccine efficacy after three doses was 100·0% (95% CI 72·1–100·0). Adverse effects attributable to the vaccine were few and mild. No vaccination-related serious adverse event was noted.
HEV 239 is well tolerated and effective in the prevention of hepatitis E in the general population in China, including both men and women age 16–65 years.
Chinese National High-tech R&D Programme (863 programme), Chinese National Key Technologies R&D Programme, Chinese National Science Fund for Distinguished Young Scholars, Fujian Provincial Department of Sciences and Technology, Xiamen Science and Technology Bureau, and Fujian Provincial Science Fund for Distinguished Young Scholars. |
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| AbstractList | Seroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Our aim was to assess efficacy and safety of a recombinant hepatitis E vaccine, HEV 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China) in a randomised, double-blind, placebo-controlled, phase 3 trial.
Healthy adults aged 16–65 years in, Jiangsu Province, China were randomly assigned in a 1:1 ratio to receive three doses of HEV 239 (30 μg of purified recombinant hepatitis E antigen adsorbed to 0·8 mg aluminium hydroxide suspended in 0·5 mL buffered saline) or placebo (hepatitis B vaccine) given intramuscularly at 0, 1, and 6 months. Randomisation was done by computer-generated permuted blocks and stratified by age and sex. Participants were followed up for 19 months. The primary endpoint was prevention of hepatitis E during 12 months from the 31st day after the third dose. Analysis was based on participants who received all three doses per protocol. Study participants, care givers, and investigators were all masked to group and vaccine assignments. This trial is registered with
ClinicalTrials.gov, number
NCT01014845.
11 165 of the trial participants were tested for hepatitis E virus IgG, of which 5285 (47%) were seropositive for hepatitis E virus. Participants were randomly assigned to vaccine (n=56 302) or placebo (n=56 302). 48 693 (86%) participants in the vaccine group and 48 663 participants (86%) in the placebo group received three vaccine doses and were included in the primary efficacy analysis. During the 12 months after 30 days from receipt of the third dose 15 per-protocol participants in the placebo group developed hepatitis E compared with none in the vaccine group. Vaccine efficacy after three doses was 100·0% (95% CI 72·1–100·0). Adverse effects attributable to the vaccine were few and mild. No vaccination-related serious adverse event was noted.
HEV 239 is well tolerated and effective in the prevention of hepatitis E in the general population in China, including both men and women age 16–65 years.
Chinese National High-tech R&D Programme (863 programme), Chinese National Key Technologies R&D Programme, Chinese National Science Fund for Distinguished Young Scholars, Fujian Provincial Department of Sciences and Technology, Xiamen Science and Technology Bureau, and Fujian Provincial Science Fund for Distinguished Young Scholars. Seroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Our aim was to assess efficacy and safety of a recombinant hepatitis E vaccine, HEV 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China) in a randomised, double-blind, placebo-controlled, phase 3 trial. Healthy adults aged 16-65 years in, Jiangsu Province, China were randomly assigned in a 1:1 ratio to receive three doses of HEV 239 (30 microg of purified recombinant hepatitis E antigen adsorbed to 0.8 mg aluminium hydroxide suspended in 0.5 mL buffered saline) or placebo (hepatitis B vaccine) given intramuscularly at 0, 1, and 6 months. Randomisation was done by computer-generated permuted blocks and stratified by age and sex. Participants were followed up for 19 months. The primary endpoint was prevention of hepatitis E during 12 months from the 31st day after the third dose. Analysis was based on participants who received all three doses per protocol. Study participants, care givers, and investigators were all masked to group and vaccine assignments. This trial is registered with ClinicalTrials.gov, number NCT01014845. 11,165 of the trial participants were tested for hepatitis E virus IgG, of which 5285 (47%) were seropositive for hepatitis E virus. Participants were randomly assigned to vaccine (n=56,302) or placebo (n=56,302). 48,693 (86%) participants in the vaccine group and 48,663 participants (86%) in the placebo group received three vaccine doses and were included in the primary efficacy analysis. During the 12 months after 30 days from receipt of the third dose 15 per-protocol participants in the placebo group developed hepatitis E compared with none in the vaccine group. Vaccine efficacy after three doses was 100.0% (95% CI 72.1-100.0). Adverse effects attributable to the vaccine were few and mild. No vaccination-related serious adverse event was noted. HEV 239 is well tolerated and effective in the prevention of hepatitis E in the general population in China, including both men and women age 16-65 years. Chinese National High-tech R&D Programme (863 programme), Chinese National Key Technologies R&D Programme, Chinese National Science Fund for Distinguished Young Scholars, Fujian Provincial Department of Sciences and Technology, Xiamen Science and Technology Bureau, and Fujian Provincial Science Fund for Distinguished Young Scholars. Summary Background Seroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Our aim was to assess efficacy and safety of a recombinant hepatitis E vaccine, HEV 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China) in a randomised, double-blind, placebo-controlled, phase 3 trial. Methods Healthy adults aged 16–65 years in, Jiangsu Province, China were randomly assigned in a 1:1 ratio to receive three doses of HEV 239 (30 μg of purified recombinant hepatitis E antigen adsorbed to 0·8 mg aluminium hydroxide suspended in 0·5 mL buffered saline) or placebo (hepatitis B vaccine) given intramuscularly at 0, 1, and 6 months. Randomisation was done by computer-generated permuted blocks and stratified by age and sex. Participants were followed up for 19 months. The primary endpoint was prevention of hepatitis E during 12 months from the 31st day after the third dose. Analysis was based on participants who received all three doses per protocol. Study participants, care givers, and investigators were all masked to group and vaccine assignments. This trial is registered with ClinicalTrials.gov , number NCT01014845. Findings 11 165 of the trial participants were tested for hepatitis E virus IgG, of which 5285 (47%) were seropositive for hepatitis E virus. Participants were randomly assigned to vaccine (n=56 302) or placebo (n=56 302). 48 693 (86%) participants in the vaccine group and 48 663 participants (86%) in the placebo group received three vaccine doses and were included in the primary efficacy analysis. During the 12 months after 30 days from receipt of the third dose 15 per-protocol participants in the placebo group developed hepatitis E compared with none in the vaccine group. Vaccine efficacy after three doses was 100·0% (95% CI 72·1–100·0). Adverse effects attributable to the vaccine were few and mild. No vaccination-related serious adverse event was noted. Interpretation HEV 239 is well tolerated and effective in the prevention of hepatitis E in the general population in China, including both men and women age 16–65 years. Funding Chinese National High-tech R&D Programme (863 programme), Chinese National Key Technologies R&D Programme, Chinese National Science Fund for Distinguished Young Scholars, Fujian Provincial Department of Sciences and Technology, Xiamen Science and Technology Bureau, and Fujian Provincial Science Fund for Distinguished Young Scholars. Seroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Our aim was to assess efficacy and safety of a recombinant hepatitis E vaccine, HEV 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China) in a randomised, double-blind, placebo-controlled, phase 3 trial.BACKGROUNDSeroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Our aim was to assess efficacy and safety of a recombinant hepatitis E vaccine, HEV 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China) in a randomised, double-blind, placebo-controlled, phase 3 trial.Healthy adults aged 16-65 years in, Jiangsu Province, China were randomly assigned in a 1:1 ratio to receive three doses of HEV 239 (30 microg of purified recombinant hepatitis E antigen adsorbed to 0.8 mg aluminium hydroxide suspended in 0.5 mL buffered saline) or placebo (hepatitis B vaccine) given intramuscularly at 0, 1, and 6 months. Randomisation was done by computer-generated permuted blocks and stratified by age and sex. Participants were followed up for 19 months. The primary endpoint was prevention of hepatitis E during 12 months from the 31st day after the third dose. Analysis was based on participants who received all three doses per protocol. Study participants, care givers, and investigators were all masked to group and vaccine assignments. This trial is registered with ClinicalTrials.gov, number NCT01014845.METHODSHealthy adults aged 16-65 years in, Jiangsu Province, China were randomly assigned in a 1:1 ratio to receive three doses of HEV 239 (30 microg of purified recombinant hepatitis E antigen adsorbed to 0.8 mg aluminium hydroxide suspended in 0.5 mL buffered saline) or placebo (hepatitis B vaccine) given intramuscularly at 0, 1, and 6 months. Randomisation was done by computer-generated permuted blocks and stratified by age and sex. Participants were followed up for 19 months. The primary endpoint was prevention of hepatitis E during 12 months from the 31st day after the third dose. Analysis was based on participants who received all three doses per protocol. Study participants, care givers, and investigators were all masked to group and vaccine assignments. This trial is registered with ClinicalTrials.gov, number NCT01014845.11,165 of the trial participants were tested for hepatitis E virus IgG, of which 5285 (47%) were seropositive for hepatitis E virus. Participants were randomly assigned to vaccine (n=56,302) or placebo (n=56,302). 48,693 (86%) participants in the vaccine group and 48,663 participants (86%) in the placebo group received three vaccine doses and were included in the primary efficacy analysis. During the 12 months after 30 days from receipt of the third dose 15 per-protocol participants in the placebo group developed hepatitis E compared with none in the vaccine group. Vaccine efficacy after three doses was 100.0% (95% CI 72.1-100.0). Adverse effects attributable to the vaccine were few and mild. No vaccination-related serious adverse event was noted.FINDINGS11,165 of the trial participants were tested for hepatitis E virus IgG, of which 5285 (47%) were seropositive for hepatitis E virus. Participants were randomly assigned to vaccine (n=56,302) or placebo (n=56,302). 48,693 (86%) participants in the vaccine group and 48,663 participants (86%) in the placebo group received three vaccine doses and were included in the primary efficacy analysis. During the 12 months after 30 days from receipt of the third dose 15 per-protocol participants in the placebo group developed hepatitis E compared with none in the vaccine group. Vaccine efficacy after three doses was 100.0% (95% CI 72.1-100.0). Adverse effects attributable to the vaccine were few and mild. No vaccination-related serious adverse event was noted.HEV 239 is well tolerated and effective in the prevention of hepatitis E in the general population in China, including both men and women age 16-65 years.INTERPRETATIONHEV 239 is well tolerated and effective in the prevention of hepatitis E in the general population in China, including both men and women age 16-65 years.Chinese National High-tech R&D Programme (863 programme), Chinese National Key Technologies R&D Programme, Chinese National Science Fund for Distinguished Young Scholars, Fujian Provincial Department of Sciences and Technology, Xiamen Science and Technology Bureau, and Fujian Provincial Science Fund for Distinguished Young Scholars.FUNDINGChinese National High-tech R&D Programme (863 programme), Chinese National Key Technologies R&D Programme, Chinese National Science Fund for Distinguished Young Scholars, Fujian Provincial Department of Sciences and Technology, Xiamen Science and Technology Bureau, and Fujian Provincial Science Fund for Distinguished Young Scholars. Seroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Our aim was to assess efficacy and safety of a recombinant hepatitis E vaccine, HEV 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China) in a randomised, double-blind, placebo-controlled, phase 3 trial. Healthy adults aged 16-65 years in, Jiangsu Province, China were randomly assigned in a 1:1 ratio to receive three doses of HEV 239 (30 µg of purified recombinant hepatitis E antigen adsorbed to 0.8 mg aluminium hydroxide suspended in 0.5 mL buffered saline) or placebo (hepatitis B vaccine) given intramuscularly at 0, 1, and 6 months. Randomisation was done by computer-generated permuted blocks and stratified by age and sex. Participants were followed up for 19 months. The primary endpoint was prevention of hepatitis E during 12 months from the 31st day after the third dose. Analysis was based on participants who received all three doses per protocol. Study participants, care givers, and investigators were all masked to group and vaccine assignments. This trial is registered with ClinicalTrials.gov, number NCT01014845. 11 165 of the trial participants were tested for hepatitis E virus IgG, of which 5285 (47%) were seropositive for hepatitis E virus. Participants were randomly assigned to vaccine (n=56 302) or placebo (n=56 302). 48 693 (86%) participants in the vaccine group and 48 663 participants (86%) in the placebo group received three vaccine doses and were included in the primary efficacy analysis. During the 12 months after 30 days from receipt of the third dose 15 per-protocol participants in the placebo group developed hepatitis E compared with none in the vaccine group. Vaccine efficacy after three doses was 100.0% (95% CI 72.1-100.0). Adverse effects attributable to the vaccine were few and mild. No vaccination-related serious adverse event was noted. HEV 239 is well tolerated and effective in the prevention of hepatitis E in the general population in China, including both men and women age 16-65 years. Chinese National High-tech R&D Programme (863 programme), Chinese National Key Technologies R&D Programme, Chinese National Science Fund for Distinguished Young Scholars, Fujian Provincial Department of Sciences and Technology, Xiamen Science and Technology Bureau, and Fujian Provincial Science Fund for Distinguished Young Scholars. |
| Author | Tang, Quan Miao, Ji Zhang, Xue-Feng Yan, Qiang Jiang, Han-Min Wang, Yi-Jun Yao, Xin Huang, Shou-Jie Yang, Chang-Lin Hu, Yue-Mei Li, Yi-Min Zhou, Cheng Wang, Zhong-Ze Xia, Ning-Shao Xian, Yang-Ling Ai, Xing Cai, Jia-Ping Zhu, Feng-Cai Wang, Hua Ng, Mun-Hon Zhang, Jun Shih, James Wai-Kuo Wu, Ting |
| Author_xml | – sequence: 1 givenname: Feng-Cai surname: Zhu fullname: Zhu, Feng-Cai organization: Jiangsu Provincial Centre for Disease Control and Prevention, Nanjing, Jiangsu Province, China – sequence: 2 givenname: Jun surname: Zhang fullname: Zhang, Jun organization: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, The Key Laboratory of the Ministry of Education for Cell Biology and Tumour Cell Engineering, Xiamen University, Xiamen, China – sequence: 3 givenname: Xue-Feng surname: Zhang fullname: Zhang, Xue-Feng organization: Jiangsu Provincial Centre for Disease Control and Prevention, Nanjing, Jiangsu Province, China – sequence: 4 givenname: Cheng surname: Zhou fullname: Zhou, Cheng organization: National Institute for the Control of Pharmaceuticals and Biological Products, Beijing, China – sequence: 5 givenname: Zhong-Ze surname: Wang fullname: Wang, Zhong-Ze organization: Dongtai Centre for Disease Control and Prevention, Dongtai, Jiangsu Province, China – sequence: 6 givenname: Shou-Jie surname: Huang fullname: Huang, Shou-Jie organization: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, The Key Laboratory of the Ministry of Education for Cell Biology and Tumour Cell Engineering, Xiamen University, Xiamen, China – sequence: 7 givenname: Hua surname: Wang fullname: Wang, Hua organization: Jiangsu Provincial Centre for Disease Control and Prevention, Nanjing, Jiangsu Province, China – sequence: 8 givenname: Chang-Lin surname: Yang fullname: Yang, Chang-Lin organization: Dongtai Centre for Disease Control and Prevention, Dongtai, Jiangsu Province, China – sequence: 9 givenname: Han-Min surname: Jiang fullname: Jiang, Han-Min organization: Dongtai Centre for Disease Control and Prevention, Dongtai, Jiangsu Province, China – sequence: 10 givenname: Jia-Ping surname: Cai fullname: Cai, Jia-Ping organization: Dongtai Centre for Disease Control and Prevention, Dongtai, Jiangsu Province, China – sequence: 11 givenname: Yi-Jun surname: Wang fullname: Wang, Yi-Jun organization: Dongtai Centre for Disease Control and Prevention, Dongtai, Jiangsu Province, China – sequence: 12 givenname: Xing surname: Ai fullname: Ai, Xing organization: Jiangsu Provincial Centre for Disease Control and Prevention, Nanjing, Jiangsu Province, China – sequence: 13 givenname: Yue-Mei surname: Hu fullname: Hu, Yue-Mei organization: Jiangsu Provincial Centre for Disease Control and Prevention, Nanjing, Jiangsu Province, China – sequence: 14 givenname: Quan surname: Tang fullname: Tang, Quan organization: Jiangsu Provincial Centre for Disease Control and Prevention, Nanjing, Jiangsu Province, China – sequence: 15 givenname: Xin surname: Yao fullname: Yao, Xin organization: National Institute for the Control of Pharmaceuticals and Biological Products, Beijing, China – sequence: 16 givenname: Qiang surname: Yan fullname: Yan, Qiang organization: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, The Key Laboratory of the Ministry of Education for Cell Biology and Tumour Cell Engineering, Xiamen University, Xiamen, China – sequence: 17 givenname: Yang-Ling surname: Xian fullname: Xian, Yang-Ling organization: Xiamen Innovax Biotech, Xiamen, China – sequence: 18 givenname: Ting surname: Wu fullname: Wu, Ting organization: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, The Key Laboratory of the Ministry of Education for Cell Biology and Tumour Cell Engineering, Xiamen University, Xiamen, China – sequence: 19 givenname: Yi-Min surname: Li fullname: Li, Yi-Min organization: Xiamen Innovax Biotech, Xiamen, China – sequence: 20 givenname: Ji surname: Miao fullname: Miao, Ji organization: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, The Key Laboratory of the Ministry of Education for Cell Biology and Tumour Cell Engineering, Xiamen University, Xiamen, China – sequence: 21 givenname: Mun-Hon surname: Ng fullname: Ng, Mun-Hon organization: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, The Key Laboratory of the Ministry of Education for Cell Biology and Tumour Cell Engineering, Xiamen University, Xiamen, China – sequence: 22 givenname: James Wai-Kuo surname: Shih fullname: Shih, James Wai-Kuo organization: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, The Key Laboratory of the Ministry of Education for Cell Biology and Tumour Cell Engineering, Xiamen University, Xiamen, China – sequence: 23 givenname: Ning-Shao surname: Xia fullname: Xia, Ning-Shao email: nsxia@xmu.edu.cn organization: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, The Key Laboratory of the Ministry of Education for Cell Biology and Tumour Cell Engineering, Xiamen University, Xiamen, China |
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| Keywords | Human Phase III trial Statistical analysis Healthy subject Toxicity Treatment efficiency Vaccination Hepatic disease Vaccine Infection Medicine Viral hepatitis A Randomization Viral disease Placebo Digestive diseases Adult Clinical trial Recombinant protein Safety Viral hepatitis E |
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| Snippet | Seroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Our aim was to assess efficacy and safety of a... Summary Background Seroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Our aim was to assess... |
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| SubjectTerms | Adolescent Adult Aged Aluminum Biological and medical sciences China Clinical medicine Codes Data collection Developing countries Double-Blind Method Fatalities Female General aspects Genotype & phenotype Hepatitis Hepatitis E - immunology Hepatitis E - prevention & control Hepatitis E virus - drug effects Hepatitis E virus - immunology Hospitals Human viral diseases Humans Immunization Immunoglobulin G - blood Infectious diseases Internal Medicine LDCs Male Medical sciences Mens health Middle Aged Mortality Prevention R&D Research & development Science Studies Treatment Outcome Vaccines Vaccines, Synthetic - administration & dosage Vaccines, Synthetic - immunology Viral diseases Viral hepatitis Viral Hepatitis Vaccines - administration & dosage Viral Hepatitis Vaccines - immunology Womens health Young Adult |
| Title | Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial |
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