Prospective clinical trial of hepatitis B vaccination for children with hematological malignancies: a study on the safety and immunogenicity efficacy
Children with hematological malignancies are at increased risk of hepatitis B virus infection. This study assessed the immunogenicity and safety profile of HBV vaccination in pediatric hemato-oncological children. A nonrandomized interventional study was conducted from January 2017 to February 2020...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2021-11-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | http://dx.doi.org/10.1080/21645515.2021.1953303 |
| _version_ | 1827806578378539008 |
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| author | Pengfei Deng Tian Yang Hua Zhang Fen Zhou Caoyi Xue Yi Fei Yijin Gao |
| author_facet | Pengfei Deng Tian Yang Hua Zhang Fen Zhou Caoyi Xue Yi Fei Yijin Gao |
| author_sort | Pengfei Deng |
| collection | DOAJ |
| description | Children with hematological malignancies are at increased risk of hepatitis B virus infection. This study assessed the immunogenicity and safety profile of HBV vaccination in pediatric hemato-oncological children. A nonrandomized interventional study was conducted from January 2017 to February 2020 in Shanghai, China. Seventy-three pediatric hemato-oncological children with hepatitis B surface antibody (anti-HBs) titers <10 mIU/ml were recruited. The participants received three doses of recombinant HBV vaccine according to the 0-, 1-, and 6- month immunization schedule. Adverse events following immunization and anti-HBs titers (at baseline, 1 month, and 6 months after inoculation) were recorded. Forty-three males and thirty females with median ages of 9.12 and 9.60 years, respectively, were included. The mean anti-HBs titer was 4.88 ± 2.61 mIU/ml, 893.12 ± 274.12 mIU/ml, and 711.45 ± 337.88 mIU/ml at baseline, one month, and six months after inoculation, respectively (P< .001). A total of fourteen adverse events following immunization were reported, and among them, 5 (6.85%), 5 (6.85%), and 4 (5.48%) events were reported after the first, second, and third inoculation, respectively (P= .927). In conclusions, the HBV vaccine is immunogenic and safe in children with hematological malignancies. It is worth noting that the anti-HBs titer was decreased at the 6-month follow-up, and periodic monitoring of the anti-HBs titer accompanied by timely booster vaccination should be carefully considered. Abbreviations: AEFI: Adverse events following immunization; HBV: Hepatitis B virus; Anti-HBs: Antibody against hepatitis B surface antigen; HBsAg: Hepatitis B surface antigen; APC: Antigen-presenting cell; HSCT: Hemopoietic stem cell transplantation; COVID-19: Corona Virus Disease 2019 |
| first_indexed | 2024-03-11T21:43:06Z |
| format | Article |
| id | doaj.art-d52204061ec44572aa7b3c39db4476e6 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T21:43:06Z |
| publishDate | 2021-11-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-d52204061ec44572aa7b3c39db4476e62023-09-26T12:47:03ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2021-11-0117114578458610.1080/21645515.2021.19533031953303Prospective clinical trial of hepatitis B vaccination for children with hematological malignancies: a study on the safety and immunogenicity efficacyPengfei Deng0Tian Yang1Hua Zhang2Fen Zhou3Caoyi Xue4Yi Fei5Yijin Gao6Shanghai Pudong New Area Center for Disease Control and PreventionShanghai Pudong New Area Center for Disease Control and PreventionShanghai Children’s Medical Center Affiliated to Shanghai Jiaotong University School of MedicineShanghai Children’s Medical Center Affiliated to Shanghai Jiaotong University School of MedicineShanghai Pudong New Area Center for Disease Control and PreventionShanghai Pudong New Area Center for Disease Control and PreventionShanghai Children’s Medical Center Affiliated to Shanghai Jiaotong University School of MedicineChildren with hematological malignancies are at increased risk of hepatitis B virus infection. This study assessed the immunogenicity and safety profile of HBV vaccination in pediatric hemato-oncological children. A nonrandomized interventional study was conducted from January 2017 to February 2020 in Shanghai, China. Seventy-three pediatric hemato-oncological children with hepatitis B surface antibody (anti-HBs) titers <10 mIU/ml were recruited. The participants received three doses of recombinant HBV vaccine according to the 0-, 1-, and 6- month immunization schedule. Adverse events following immunization and anti-HBs titers (at baseline, 1 month, and 6 months after inoculation) were recorded. Forty-three males and thirty females with median ages of 9.12 and 9.60 years, respectively, were included. The mean anti-HBs titer was 4.88 ± 2.61 mIU/ml, 893.12 ± 274.12 mIU/ml, and 711.45 ± 337.88 mIU/ml at baseline, one month, and six months after inoculation, respectively (P< .001). A total of fourteen adverse events following immunization were reported, and among them, 5 (6.85%), 5 (6.85%), and 4 (5.48%) events were reported after the first, second, and third inoculation, respectively (P= .927). In conclusions, the HBV vaccine is immunogenic and safe in children with hematological malignancies. It is worth noting that the anti-HBs titer was decreased at the 6-month follow-up, and periodic monitoring of the anti-HBs titer accompanied by timely booster vaccination should be carefully considered. Abbreviations: AEFI: Adverse events following immunization; HBV: Hepatitis B virus; Anti-HBs: Antibody against hepatitis B surface antigen; HBsAg: Hepatitis B surface antigen; APC: Antigen-presenting cell; HSCT: Hemopoietic stem cell transplantation; COVID-19: Corona Virus Disease 2019http://dx.doi.org/10.1080/21645515.2021.1953303hepatitis b vaccinationhematological malignancieschildrenimmunogenicitysafety |
| spellingShingle | Pengfei Deng Tian Yang Hua Zhang Fen Zhou Caoyi Xue Yi Fei Yijin Gao Prospective clinical trial of hepatitis B vaccination for children with hematological malignancies: a study on the safety and immunogenicity efficacy Human Vaccines & Immunotherapeutics hepatitis b vaccination hematological malignancies children immunogenicity safety |
| title | Prospective clinical trial of hepatitis B vaccination for children with hematological malignancies: a study on the safety and immunogenicity efficacy |
| title_full | Prospective clinical trial of hepatitis B vaccination for children with hematological malignancies: a study on the safety and immunogenicity efficacy |
| title_fullStr | Prospective clinical trial of hepatitis B vaccination for children with hematological malignancies: a study on the safety and immunogenicity efficacy |
| title_full_unstemmed | Prospective clinical trial of hepatitis B vaccination for children with hematological malignancies: a study on the safety and immunogenicity efficacy |
| title_short | Prospective clinical trial of hepatitis B vaccination for children with hematological malignancies: a study on the safety and immunogenicity efficacy |
| title_sort | prospective clinical trial of hepatitis b vaccination for children with hematological malignancies a study on the safety and immunogenicity efficacy |
| topic | hepatitis b vaccination hematological malignancies children immunogenicity safety |
| url | http://dx.doi.org/10.1080/21645515.2021.1953303 |
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