HEBERBIOVAC HB vaccine to reference material.
- Conditions
- Prophylaxis of Hepatitis B virus infection.Healthy Volunteers
- Registration Number
- RPCEC00000244
- Lead Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 190
1. Voluntariness of the subject through the signing of informed consent.
2. Age between 35 and 55 years.
3. Subjects of both sexes.
4. Do not present evidence of decompensated organic or psychiatric disease according to questioning and physical examination.
5. Women of childbearing age who use a contraceptive method and continue their use throughout the study.
6. Post-menopausal woman (with at least 2 years of amenorrhea) or documented history of hysterectomy and / or double annexectomy.
1. History of Hepatitis B virus infection.
2. Positivity for Hepatitis B surface antigen (HBsAg +) or presence of antibodies against surface antigen (Anti-HBs).
3. Pregnancy, puerperium or breastfeeding.
4. Acute infection of any type requiring specific treatment.
5. Decompensated chronic diseases (High blood pressure, Diabetes mellitus, Chronic renal failure, Heart failure, Ischemic heart disease).
6. Severe allergic history (Urticaria, Atopic dermatitis, Severe bronchitis, Grade III or IV bronchial asthma).
7. Immunosuppressive treatment in the 6 months prior to inclusion in the study.
8. Allergy to Thiomersal or any component of the vaccine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method