Clinical Trial Heberbiovac HB vaccine Material Reference Batch
- Conditions
- Hepatitis B prophylaxis
- Registration Number
- RPCEC00000109
- Lead Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB).
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 246
1) Apparently healthy subjects, both sexes. 2) Age from 18 up to 65 years old. 3) Current contraceptive device use for women on reproductive age or not planning a pregnancy in the forthcoming six month after enrollment in the trial. 4) Signing of the written inform consent act.
1) History of viral hepatitis type B or previous vaccination against Hepatitis B. 2) Seropositivity for HBsAg (HBsAg+) 3) Underlying immunosuppressive disease, current intake of immunosuppressor drugs (including steroids) in the six month period prior to study entry. 4) Non-controlled Chronic diseases (eg. Arterial hypertension, Diabetes mellitus, renal failure, heart failure, hyper-thiroidism, malignant neoplasia, epilepsy, etc), autoimmune disease (Systemic lupus erithematosus, rheumatoid arthritis, Multiple sclerosis, Type 1 Diabetes Mellitus, etc.) 5) Feverish states (>37.5°C) at the moment of each vaccination visit 6) History of severe allergy (Asthma Grade III or IV, urtycaria, Dermatitis, Bronchitis, etc.). 7) History of thiomersal allergy or allergy to any component of the vaccine. 8) Pregnancy or breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seroprotection percentage (+ de 10 UI of AntiHBs antibodies). Measuring time: 90 days after the administration of the first vaccine dose. Hyper-responder rate (+ de 1000 UI, Yes/No). Measuring time: 90 days after the administration of the first vaccine dose. antiHBs GMT. Measuring time: 90 days after the administration of the first vaccine dose.
- Secondary Outcome Measures
Name Time Method ocal and systemic adverse events, within 72 hours, and at 7 and 30 days after vaccination in each dose.