Phase I clinical trial for the evaluation of the therapeutic vaccine candidate Terap C.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000043
• Date of registration: 11/06/2010
• Primary sponsor: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
• Public title: Phase I clinical trial for the evaluation of the therapeutic vaccine candidate Terap C.
• Scientific title: EVALUATION OF SAFETY AND PHARMACODINAMY OF TERAP C: A VACCINE PREPARATION FOR THERAPEUTIC USE IN THE TREATMENT OF CHRONIC HEPATITIS CAUSED BY HEPATITIS C VIRUS. PHASE I CLINICAL TRIAL, NOT CONTROLLED, NOT RANDOMIZED, NOT BLINDED.
• Date of first enrolment: 06/09/2006
• Target sample size: 15
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000043-En
• Study type: Interventional
• Study design: Randomization: Nonrandomized Trial Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Santiago Dueñas-Carrera
• Affiliation: Department of Clinical Trials, Vaccine Division, Biomedical Research, Center for Genetic Engineering and Biothecnology (CIGB).

• Name: Zurina Estevez
• Affiliation: Department of Clinical Trials, Vaccine Division, Biomedical Research, Center for Genetic Engineering and Biothecnology (CIGB).

Key inclusion & exclusion criteria

Inclusion criteria: 1.Adults of both genders. 2.Age between 18 and 60 years. 3.Clinical history of chronic hepatitis caused by hepatitis C virus (confirmed by liver biopsy in the last 12 months before starting the clinical study, anti-HCV positive by UMELISA VHC, HCV RNA positive by UMELOSA VHC). 4.Patients non-responders to previous treatment with IFN alpha-2b and Ribavirin. 5.HCV RNA genotype 1b. 6.Informed consent signed.
Exclusion criteria: 1.Positive to serum markers of infection with hepatitis A virus (HAV) or hepatitis B virus (HBV). 2. Positive to serum markers of infection human immunodeficiency virus (HIV-1, 2). 3.Patients with concomitant background liver disease of any other cause (alcoholism, autoimmune hepatitis, toxic, Wilson´s disease, haemochromatosis, obesity). 4.Women in fertile age that use hormone-based contraceptive methods. 5.Women and men in reproductive age without contraceptive control. 6.Pregnancy and breastfeeding. 7.Chronic no-compensated disease (high blood pressure, diabetes mellitus, chronic renal insufficiency, heart insufficiency, thyroid alterations, epilepsy, cancer, severe mind depression, etc.). 8.Patients with previous diagnosis of blood alterations (leukemia, hemophilia, and others). 9.Liver histology indicating cirrhosis or hepatocellular carcinoma. 10.Values in evaluations of clinical laboratory indicating alterations before start the treatment. 11.Concomitant immunosuppresive disease, consumption of immunosuppresive/ immunomodulators drugs (steroids, colony stimulating factor, etc.) in the six months previous to the study. 12.Documented autoimmune disease (systemic erithematosus lupus, reumatoid arthritis, multiple sclerosis, diabetes mellitus type I, etc.). 13.Patients with background of severe allergy (asthma degree III or IV, urticary, dermatitis, bronchitis, etc.). 14.Disease with fever (body temperature above >37.8°C) in the moment or 24 hours previous to the administration of the vaccine, or acute infectious disease suggested by clinical evaluation.

Age minimum: 18 years
Age maximum: 60 years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic hepatitis C.

Intervention(s)

The preparation Terap C, based on the mixture of a recombinant HCV core protein (Co.120) with a DNA (plasmid pIDKE2) encoding for HCV structural proteins (Core, E1, y E2) of a Cuban isolate genotype 1b, was administered by intramuscular injection, 6 immunizations, four weeks interval between each dose, in 15 individuals, non responders to previous treatment with interferon plus ribavirin. In each administration of Terap C, 0.5 mL containing 0.5 mg of pIDKE2 and 0.05 mg of Co.120 are injected.

Primary Outcome(s)

Safety. Adverse events were evaluated during the first 3 days after each vaccine inoculation, under hospital system, as well as 7, 14, 21 and 28 days after each vaccine inoculation, in primary attention.

Secondary Outcome(s)

Secondary Outcome: Immune response. Evaluation of the generation or enhancement of antibody or lymphoproliferative response at weeks 4, 8, 12, 16, 20 and 24 after the beginning of treatment. Secondary Outcome: Viral load. Quantification of HCV RNA in each patient at weeks 0, 12 and 24. Elimination or reduction in at least 2 logs the viral load. Secondary Outcome: Biochemical parameters: Evaluation of Alanine-aminotransferase (ALAT), Aspartate-aminotransferase (ASAT), creatinine, bilirubin, alkaline phosphatase, gamma GT), at weeks 4, 8, 12, 16, 20 and 24, after the beginning of treatment with the vaccine candidate. Secondary Outcome: Liver histology. Analysis of liver biopsy previous and 24 weeks after the beginning of treatment.

Secondary ID(s)

IG/VHI/HC/0503

Source(s) of Monetary Support

Heber Biotec S.A.