Chronic Hepatitis B Virus infection
Conditions
Interventions
All patients will receive HeberNasvac® according to the vaccine package insert:
Schedule: 0-2-4-6-8-12-14-14-18-18-20 weeks
First cycle:
HeberNasvac® intranasal dispersant: (0.10 mg HBsAg + 0.10 mg HB
Hepatitis B Surface Antigens
Immunotherapy, Active
Administration, Intranasal
HeberNasvac
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female subjects = 18 years of age. 2. Documented chronic hepatitis B determined by HBsAg + for more than 6 months. 3. Voluntariness of the patient to participate expressed by delivery of signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Evidence or suspicion of hepatocarcinoma and/or liver cirrhosis by clinical/sonography. 2. Clinical, sonographic or serological evidence of decompensated liver disease (gastrointestinal bleeding, hepatic encephalopathy, ascites, spontaneous peritonitis, hepato-renal syndrome, ALT greater than 500 IU / L). 3. History of liver transplantation. 4. Have received antiviral therapy for chronic hepatitis B (IFN, PEG-IFN, or nucleos(t)ide analogue) in the 6 months prior to inclusion. 5. Immunosuppressive therapy in the six months prior to the screening visit. 6. History of allergy to any of the ingredients of the vaccine. 7. Pregnancy, breast feeding or female subjects who do not use contraceptive methods or who plan a pregnancy that coincides with the course of treatment. 8. Presence of mental and / or psychiatric disorders that make it impossible to sign informed consent or patient follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance of HBsAg in serum (Qualitative determination of HBsAg by UltramicroELISA (UMELISA HBsAg)). Measurement time: At baseline and, weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients with decreased viral load (HBV DNA) below the limit of detection during follow-up with respect to time zero (Quantification of HBV DNA. Polymerase Chain Reaction (PCR) to detection and quantification of HBV). Measurement time: Before the start of treatment and in weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 2. Percentage of patients with significant reduction in viral load in at least 1 log HBV DNA in any of the follow-up extractions with respect to time zero (Quantification of HBV DNA. Polymerase Chain Reaction (PCR) to detection and quantification of HBV). Measurement time: Before the start of treatment and in weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 3. Percentage of patients with suppression of viral load, HBV DNA below 10 000 copies / ml considering viral load at the beginning of treatment (Quantification of HBV DNA. Polymerase Chain Reaction (PCR) to detection and quantification of HBV). Measurement time: Before the start of treatment and in weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240. 4. Percentage of HBeAg loss in positive HBeAg patients at the start of treatment (HBeAg detection, ELISA HBeAg/anti-HBe (Commercial kit)).Measurement time: Before the start of treatment and in weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 5. Percentage of seroconversion to HBeAg in positive HBeAg patients at the start of treatment (HBeAg, Anti-HBe ELISA HBeAg/anti-HBe (Commercial kit)). Measurement time: Before the start of treatment and in weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240. 6. Percentage of patients with significant reduction in the quantification of HBsAg (Quantification of HBsAg. Household ELISA using UMELISA HBsAg, (Commercial kit) and, a commercial standard for the quantification curve). Measurement time: Before the start of treatment and in weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 7. Percentage of seroconversion to HBsAg (HBsAg detection (qualitative), | — |
Countries
Cuba
Contacts
Public ContactPablo Diaz Reyes
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed