Prospective clinical trial of hepatitis B vaccination for children with hematological malignancies: a study on the safety and immunogenicity efficacy

ABSTRACT

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

KEYWORDS:

• Hepatitis B vaccination
• hematological malignancies
• children
• immunogenicity
• safety

Supplemental Material

Supplemental data for this article can be accessed on the publisher’s website at https://doi.org/10.1080/21645515.2021.1953303.

Acknowledgments

The authors appreciate the assistance from the Department of Hematology and Oncology Shanghai Children’s Medical Center affiliated with Shanghai Jiaotong University School of Medicine, Shanghai, China.

Authors’ contribution statement

The study protocol was designed by DPF, FY and GYJ. Data collection was done by YT, ZH, ZF, YDD and WWP. Data analysis was completed by DPF, XCY and GYJ. DPF, YT and GYJ prepared the manuscript which was reviewed by all authors.

Disclosure of potential conflicts of interest

No potential conflicts of interest were disclosed.

Provenance and peer review

Not commissioned; externally peer reviewed.

Additional information

Funding

The study was funded by the Outstanding Young Talent Project of Shanghai Grant [Number GWV-10.2-YQ38].