Phase 4 N=353 Randomized Prevention

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

Hepatitis B

Bottom Line

View on ClinicalTrials.gov: NCT02203357 ↗

Enrolled (actual)

353

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults — 1847.99; 839.27; 1244.8 mIU/ml — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Hepatitis B vaccine (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Peking University
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults	427.46; 89.74; 89.80	—
SECONDARY Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults	427.46; 89.74; 89.80	—
SECONDARY Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults	427.46; 89.74; 89.80	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02203357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.