HEBERBIOVAC HB vaccine to reference material.

Phase 4

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

Inclusion Criteria

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.

Exclusion Criteria

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
Seroprotection (defined as titers of anti-Hbs=10 IU / L). Measurement time: 30 days after the third dose (day 90).

Secondary Outcome Measures

Name	Time	Method
Immunogenicity (seroprotection = 10 IU / L at day 60 of the immunization schedule and = 100 IU / L after the second and third doses administered). Measurement time: at 60 and 90 days after the start of the immunization schedule.<br>Adverse clinical events-AE (Occurrence of AE (Yes, No) Description of AE (name of event) Intensity of AE (mild, moderate, severe). Measurement time: first 72 hours and at 30, 60 and 90 days of initiation of the immunization schedule.