Immunogenicity persistence in children of hepatitis A vaccines Healive® and Havrix®: 11 years follow-up and long-term prediction
Background: Hepatitis A vaccine has been used in mass and routine public vaccination programs in China. Long-term follow-up studies are required to determine the duration of protection and the need for booster vaccinations. Methods: A prospective, randomized, open-label clinical trial was performed...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2020-10-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | http://dx.doi.org/10.1080/21645515.2020.1715687 |
| _version_ | 1827809571167535104 |
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| author | Yongji Wang Yangyang Qi Wenguo Xu Yuansheng Hu Ling Wang Yongpei Yu Zhiwei Jiang Jielai Xia Gang Zeng Yalong Wang |
| author_facet | Yongji Wang Yangyang Qi Wenguo Xu Yuansheng Hu Ling Wang Yongpei Yu Zhiwei Jiang Jielai Xia Gang Zeng Yalong Wang |
| author_sort | Yongji Wang |
| collection | DOAJ |
| description | Background: Hepatitis A vaccine has been used in mass and routine public vaccination programs in China. Long-term follow-up studies are required to determine the duration of protection and the need for booster vaccinations. Methods: A prospective, randomized, open-label clinical trial was performed to compare the geometric mean concentration (GMC) and seroprotection rates of anti-Hepatitis A virus (HAV) antibodies elicited by the inactivated vaccines Healive and Havrix. 400 healthy children were randomly assigned 3:1 ratio to receive two doses of Healive or Havrix at 0 and 6 months. Persistence of anti-HAV antibodies for 5 years post immunization has been reported The current study reports new data at 11 years post immunization for the purpose of showing antibody persistence. Sensitivity analyzes were performed to assess the results. In addition, predictions for long-term antibody persistence were performed using a statistical model. Two different serological assays were used that were shown to be 98.3% concordant for detecting anit-HAV antibody. Results: GMCs were significantly higher following Healive compared to Havrix at 1, 6, 7, 66, 112 and 138 months post-vaccination. In addition, the GMCs obtained using sensitivity analysis were very similar to those obtained using the original models. Prediction analysis indicated that the duration of protection for both vaccines was at least 30 years after immunization, with a lower limit of the 95% confidence interval for GMC of greater than 20mIU/mL. Conclusions: Healive is more immunogenic than Havrix in children at 11 years post full immunization. Prediction analysis indicated at least 30 years of antibody persistence for both vaccines. |
| first_indexed | 2024-03-11T22:43:20Z |
| format | Article |
| id | doaj.art-003095164e794b2faf3325b126d1087b |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:43:20Z |
| publishDate | 2020-10-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-003095164e794b2faf3325b126d1087b2023-09-22T08:45:35ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2020-10-0116102559256410.1080/21645515.2020.17156871715687Immunogenicity persistence in children of hepatitis A vaccines Healive® and Havrix®: 11 years follow-up and long-term predictionYongji Wang0Yangyang Qi1Wenguo Xu2Yuansheng Hu3Ling Wang4Yongpei Yu5Zhiwei Jiang6Jielai Xia7Gang Zeng8Yalong Wang9Air Force Military Medical UniversityBeijing Key Tech Statistical Consulting Co., LtdCenter for Disease Control and Prevention of Changzhou CitySinovac BiotechAir Force Military Medical UniversityPeking University Clinical Research Institute, Peking University Health Science CenterBeijing Key Tech Statistical Consulting Co., LtdAir Force Military Medical UniversitySinovac BiotechCenter for Disease Control and Prevention of Changzhou CityBackground: Hepatitis A vaccine has been used in mass and routine public vaccination programs in China. Long-term follow-up studies are required to determine the duration of protection and the need for booster vaccinations. Methods: A prospective, randomized, open-label clinical trial was performed to compare the geometric mean concentration (GMC) and seroprotection rates of anti-Hepatitis A virus (HAV) antibodies elicited by the inactivated vaccines Healive and Havrix. 400 healthy children were randomly assigned 3:1 ratio to receive two doses of Healive or Havrix at 0 and 6 months. Persistence of anti-HAV antibodies for 5 years post immunization has been reported The current study reports new data at 11 years post immunization for the purpose of showing antibody persistence. Sensitivity analyzes were performed to assess the results. In addition, predictions for long-term antibody persistence were performed using a statistical model. Two different serological assays were used that were shown to be 98.3% concordant for detecting anit-HAV antibody. Results: GMCs were significantly higher following Healive compared to Havrix at 1, 6, 7, 66, 112 and 138 months post-vaccination. In addition, the GMCs obtained using sensitivity analysis were very similar to those obtained using the original models. Prediction analysis indicated that the duration of protection for both vaccines was at least 30 years after immunization, with a lower limit of the 95% confidence interval for GMC of greater than 20mIU/mL. Conclusions: Healive is more immunogenic than Havrix in children at 11 years post full immunization. Prediction analysis indicated at least 30 years of antibody persistence for both vaccines.http://dx.doi.org/10.1080/21645515.2020.1715687hepatitis avaccinepersistenceseroprotectionlong termimmunogenicity |
| spellingShingle | Yongji Wang Yangyang Qi Wenguo Xu Yuansheng Hu Ling Wang Yongpei Yu Zhiwei Jiang Jielai Xia Gang Zeng Yalong Wang Immunogenicity persistence in children of hepatitis A vaccines Healive® and Havrix®: 11 years follow-up and long-term prediction Human Vaccines & Immunotherapeutics hepatitis a vaccine persistence seroprotection long term immunogenicity |
| title | Immunogenicity persistence in children of hepatitis A vaccines Healive® and Havrix®: 11 years follow-up and long-term prediction |
| title_full | Immunogenicity persistence in children of hepatitis A vaccines Healive® and Havrix®: 11 years follow-up and long-term prediction |
| title_fullStr | Immunogenicity persistence in children of hepatitis A vaccines Healive® and Havrix®: 11 years follow-up and long-term prediction |
| title_full_unstemmed | Immunogenicity persistence in children of hepatitis A vaccines Healive® and Havrix®: 11 years follow-up and long-term prediction |
| title_short | Immunogenicity persistence in children of hepatitis A vaccines Healive® and Havrix®: 11 years follow-up and long-term prediction |
| title_sort | immunogenicity persistence in children of hepatitis a vaccines healive r and havrix r 11 years follow up and long term prediction |
| topic | hepatitis a vaccine persistence seroprotection long term immunogenicity |
| url | http://dx.doi.org/10.1080/21645515.2020.1715687 |
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