Condition 1: Acute Hepatitis B. Condition 2: Chronic (viral) hepatitis B. Acute hepatitis B Chronic (viral) hepatitis B
Conditions
Interventions
Intervention 1: Hepatitis B vaccine produced by Pasteur Institute of Iran (intervention group) in 3 course. Month 0, month 1 and month 6. Intervention 2: Hepatitis B vaccine produced by Heber Biotec
Prevention
Hepatitis B vaccine produced by Pasteur Institute of Iran (intervention group) in 3 course. Month 0, month 1 and month 6.
Hepatitis B vaccine produced by Heber Biotech Institute of Cuba (Control group) in 3 course. month 0, month 1, and month six.
Sponsors
Pasteur Institute of Iran (IPI)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAb serum titre. Timepoint: Respectively, one, six and seven month after incubation of first vaccine. Method of measurement: ELISA test. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMostafa Shafiei
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Outcome results
None listed