Prospective clinical trial of hepatitis B vaccination for children with hematological malignancies: a study on the safety and immunogenicity efficacy.
Hum Vaccin Immunother
; 17(11): 4578-4586, 2021 11 02.
Article
in English
| MEDLINE | ID: covidwho-1348031
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
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Hepatitis B Vaccines
/
Hematologic Neoplasms
/
Hepatitis B
Type of study:
Cohort study
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Topics:
Long Covid
/
Vaccines
Limits:
Child
/
Female
/
Humans
/
Male
Country/Region as subject:
Asia
Language:
English
Journal:
Hum Vaccin Immunother
Year:
2021
Document Type:
Article
Affiliation country:
21645515.2021.1953303
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