A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults

Peking University

Status and phase: Completed; Phase 4

Conditions: Hepatitis B

Treatments: Biological: Hepatitis B vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02203357

HepB-2014

Details and patient eligibility

About

The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young adults, and the comparative immunogenicity among the three groups will be measured at 1 mon post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore, the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.

Enrollment: 353 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy subjects aged between 16 and 25 as established by medical history and clinical examination
• Written informed consent will be obtained from each subject before the serum screening of HBV markers
• Seronegative for HBsAg, anti-HBs antibody, anti-HBc antibody
• Have never been immunized with HBV vaccine before

Exclusion criteria

• Subject has a medical history of allergic to any ingredient of vaccine
• Family history of seizures or progressive neurological disease
• Autoimmune disease or immunodeficiency
• Women with pregnant
• Bleeding disorder diagnosed by a doctor
• Chronic diseases: hepatitis, tumor, tuberculosis,et.al
• Any prior administration of immunoglobulins or blood products in the last 3 mon before recruitment
• Subjects had a medical history of serious adverse reactions to vaccines

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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353 participants in 3 patient groups

20μg, 0-1-6

Active Comparator group

Description:

117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.

Treatment:

Biological: Hepatitis B vaccine

60μg, 0-1

Experimental group

Description:

112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.

Treatment:

Biological: Hepatitis B vaccine

60μg, 0-2

Experimental group

Description:

125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.

Treatment:

Biological: Hepatitis B vaccine