Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Adverse events (Yes, No). Measuring time: 6 hours, 24 hours, 48 ??hours, 72 hours and 7 days after each dose of vaccine nasal. Severity of reported adverse events (mild, moderate, severe). Measuring time: 6 hours, 24 hours, 48 ??hours, 72 hours and 7 days after each dose of vaccine nasal.
Key secondary outcomes:
Quantitative PCR (quantification of viral load of hepatitis B virus in the blood). Measuring Time: Weeks 12, 24, 36 and 48 after the start of the immunization schedule. Anti-HBsAg antibodies (Positive, Negative). Measuring Time: Weeks 12, 24, 36 and 48 after the start of the immunization schedule. Anti-HBeAg (Positive, Negative). Measuring Time: Weeks 12, 24, 36 and 48 after the start of the immunization schedule. HBsAg (Positive, Negative). Measuring Time: Weeks 12, 24, 36 and 48 after the start of the immunization schedule. Presence of HBeAg (Positive, Negative). Measuring Time: Weeks 12, 24, 36 and 48 after the start of the immunization schedule. Proliferative cellular response capacity of IFN gamma secretion in cultured cells stimulated with HBsAg and HBcAg antigens (lymphocyte proliferation index). Measuring Time: Weeks 14, 28, 40 and 52 after the start of the immunization schedule. Determination of basic haematological and clinical chemistry (amount of ALT, AST, creatinine, bilirubin and alkaline phosphatase). Measuring time: Weeks 2, 4, 6, 8, 10, 12, 14, 16.1 8, 20, 22, 24, 28, 32, 36, 40, 44, 48 and 52 after the start of the immunization schedule.