Immunogenicity and reatogenicity of Hepatitis B vaccine derived from Hansenula polymorpha compared to Saccharomyces cerevisiae in men deprived of their liberty
Not Applicable
- Conditions
- Hepatitis BD12.776.124.486.485.114.254.450.504SP9.020.080.010.020
- Registration Number
- RBR-27bn6z
- Lead Sponsor
- Faculdade de Enfermagem Universidade Federal de Goiás
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Susceptible to infection by hepatitis B virus infection (anti-HBs marker alone);
Being male;
Age between 18 years;
Prison regime in the Regional Prison of Itumbiara with penalty expected for more than eight months.
Exclusion Criteria
To present any clinical picture that contraindicates hepatitis B vaccination;
Effect of substances that compromise the data response and the integrity of the researchers;
Medical diagnosis of mental disorders;
Present at the time of data collection behavior that endangers the physical and / or emotional health of the researcher.
To present difficulty of understanding in order to respond to the instrument of data collection (auditory deficiency and / or altered speech).
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum titre of quantitative anti-HBs antibodies (greater than 10 mIU / mL = protective titres) determined after the hepatitis B vaccination schedule is expected. Blood will be collected 30 to 45 days after the last dose of the vaccine and will be evaluated by the electrochemiluminescence assay.
- Secondary Outcome Measures
Name Time Method The level of pain less than 10 (worse pain) reported after the administration of each dose of the vaccine is expected using the analog pain scale;It is expected that the individual will not reattagenicity after each dose of hepatitis B vaccine given;It is expected that sex, age, obesity, smoking and autoimmune diseases alter titration response (less than 10 mIU / mL) after vaccination. The SPSS 13.0 program will be used