Viral hepatitis type B.
Conditions
Interventions
Study group (HeberbiovacHB vaccine obtained by optimizing the manufacturing process): 3 doses of 20µg/mL per dose by the intramuscular route, according to the schedule 0-1-2 months. Control group (Heb
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB).
Ministry of Public Health, CUBA.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Healthy apparent subjects from both sexes. 2) Age from 18 up to 65 years old. 3) Current contraceptive device use for women on reproductive age. 4) Signing of the written inform consent sheet.
Exclusion criteria
Exclusion criteria: 1) History of viral hepatitis type B or previous vaccination against Hepatitis B. 2) Seropositivity for HBsAg. 3) Underlying immunosuppressive disease, intake of immunosuppressor drugs (including steroids) in the six month period prior to study entry. 4) Non-controlled Chronic diseases. 5) Feverish states (>37.5°C) at the momento of vaccination. 6) History of severe allergy. 7) History of allergy to any component of the vaccine or to thiomersal. 8) Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Local and systemic adverse events, within 72 hours, and at 7 and 30 days after vaccination in each dose. | — |
Countries
Cuba
Contacts
Public ContactDr. Arístides Aguilar Betancourt
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed