Comparing the Efficacy and Safety of Hepatitis B vaccine of Pasteur Institute of Iran and Cuban Heber biotec Company’s in Iranian healthy volunteers

Phase 2

• Conditions: Condition 1: Acute Hepatitis B. Condition 2: Chronic (viral) hepatitis B.; Acute hepatitis B; Chronic (viral) hepatitis B

• Registration Number: IRCT201109113307N5
• Lead Sponsor: Pasteur Institute of Iran (IPI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

Healthy volunteers
completed inform consent
Exclusion criteria:
HBsAg+ or HBcAb+ patients
Previous incubation of hepatitis B vaccine or serum HBsAb >10 mIU/ml before the first dose of vaccine incubation
Patients with: Thalassemia, any malignancies, Immunodeficiency, HIV, DM, Liver failure and dialysis patients

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HBsAb serum titre. Timepoint: Respectively, one, six and seven month after incubation of first vaccine. Method of measurement: ELISA test.

Secondary Outcome Measures

Name	Time	Method
Vaccination adverse events. Timepoint: Respectively, one, six and seven month after incubation of first vaccine. Method of measurement: Based on history and measured blood biochemical variables.