Safety and immunogenicity of commercial Hepatitis B vaccines.
- Conditions
- Hepatitis B (Prevention).Hepatitis BHepatitisHepatitis, Viral, HumanLiver DiseasesDigestive System DiseasesVirus DiseasesHepadnaviridae InfectionsDNA Virus Infections
- Registration Number
- RPCEC00000031
- Lead Sponsor
- Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 400
1.Healthy adults from both sexes. 2.Age range: 18 until 45 years old. 3.Current use of contraceptive method for women of fertile age. 4.Written informed consent obtained.
1.Known history of infection with hepatitis B or present antibodies surface antigen (antiHBs) prior to the inclusion (including pre-vaccination anti-hepatitis B). 2.Positive for surface antigen of hepatitis B (HBsAg +). 3.Underlying immunosuppressive disease, ingestion of current immunosuppressive drugs (including steroids) or in the six months prior to study. 4.People who are decompensated chronic diseases (hypertension, diabetes mellitus, renal failure, heart failure, hyperthyroidism, malignancy, epilepsy, etc.). Or suffer from any autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, diabetes mellitus type 1 , etc). 5.Persons with a severe allergy (asthma grade III or IV, hives, dermatitis, bronchitis, etc). 6.Thiomersal allergy or any of the components of the vaccine. 7.Pregnancy and lactancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunogenicity (seroprotection percentage [antiHBs=10 UI/L], hyper-responders [antiHBs=1000UI/L] and geometric mean titers of anti-HBs [antiHBs GMT] at 60 and 90-days postvaccination).
- Secondary Outcome Measures
Name Time Method Reactogenicity, adverse events rate in each dose (first 72 hours), 7 and 30 days post-vaccination.