NASVAC therapeutic vaccine study

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000110
• Date of registration: 16/05/2011
• Primary sponsor: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
• Public title: NASVAC therapeutic vaccine study
• Scientific title: “Safety, Tolerance and preliminary Efficacy of nasal administration of NASVAC therapeutic vaccine candidate in chronic hepatitis B patients- A phase I, open, not controlled clinical trial”.
• Date of first enrolment: 28/01/2010
• Target sample size: 20
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000110-En
• Study type: Interventional
• Study design: Randomization: Nonrandomized Trial Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Aristides Aguilar Betancourt
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

• Name: Aristides Aguilar Betancourt
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

Key inclusion & exclusion criteria

Inclusion criteria: 1) Adults from 18 to 65 years old, both sexes. 2) HBsAg seropositivity longer than six months. 3) Serum ALT levels over the upper normal limit detected (at least one time) during the six month period prior to study enrollment. 4) Previous treatment with alpha 2b interferon or with hepatitis specific antivirals that failed to control viral infection. Patients considered intolerant to standard treatment due to medical criteria or adverse reactions to this kind of therapy are also allowed to enter the study. 5) Six month washout period of the last treatment with interferon or other antivirals. 6) Inform Consent Act signed by the subject.
Exclusion criteria: 1) History of acute or chronic diseases of respiratory airways. 2) Seropositivity for markers of Hepatitis C virus infection (HCV). 3) Seropositivity for markers of Human Immunodeficiency Virus infection (HIV1, 2). 4) Women in reproductive age without a birth control method or using a hormonal contraceptive. 5) Pregnancy, puerperium or breastfeeding. 6) Uncontrolled chronic diseases (eg., high blood pressure, diabetes mellitus, renal failure, heart failure, malignant neoplasia, hyperthyroidism, autoimmune diseases, epilepsy, severe mental depression, etc). 7) Treatment with Interferon or any other HBV specific systemic antiviral agent (eg. Lamivudine) in the 6 month prior to study enrollment. 8) History of concomitant liver diseases of any aethiology, ie. Alcoholism, autoimmune hepatitis, toxic hepatitis, Wilson´s Disease, Haemochromatosis. 9) History of liver transplantation, cirrhosis, or primary liver hepatocacinoma (diagnosis made by clinic or ultrasonography). 10) ALT or AST values over 500 U/L detected at any moment during the study. 11) Fever higher than 37.8ºC during or 24 hours prior to nasal administration of the vaccine candidate or acute infectious disease suspected by clinical examination. 12) History of receiving another experimental product or hepatitis B vaccine in the six months prior to study enrollment. 13) Haemoglobin levels below 9g/L, platelet levels below 50x109 /L, Global leukocyte count > 12x109 cells/L or below 3 x109 cells/L. 14) Underlying immunosuppressive disease or immunosuppressive/immunostimulantory drugs intake (including steroids) in the six month prior to study entry. 15) History of severe allergy that need continued treatment with steroids (Grade III or IV Asthma, urtycaria, Dermatitis, Bronchitis, etc). 16) Obvious mental incapacity to give written consent or to allow follow up of the patient.

Age minimum: 18 years
Age maximum: 65 years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Hepatitis B

Intervention(s)

The NASVAC vaccine will be administered to a unique treatment group, by the nasal route using a nasal spray device (Valois), according to the dose 100µg HBsAg + HBcAg, final volume: 1mL, following a 10 dose schedule separated at 14 days intervals.

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.

Secondary Outcome(s)

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.

Secondary ID(s)

IG/VH-IN/HB/0802

Source(s) of Monetary Support

HeberBiotec S.A.

Secondary Sponsor(s)

Ministry of Public Health, CUBA.