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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Evaluation of safety and pharmacodinamy of TERAP C: Aa 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.

Secondary indentifying numbers:

IG/VHI/HC/0503

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Heber Biotec S.A.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

01/06/2006

Reference number:

No. 992/06.04.0513.

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Marlen

Last name:

Castellanos Fernandez

Medical Specialty :

II Degree Specialist in Gastroenterology

Affiliation:

Institute of Gastroenterology

Postal address:

Calle 25 No. 503 entre H e I

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78325594

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Ethics Committee from the Gastroenterology Institute, Approval date: November 7, 2005.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

06/09/2006

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Chronic hepatitis C.

Health condition(s) code:

Hepatitis C, Chronic

Hepatitis C

Hepatitis, Chronic

Hepatitis

Hepatitis, Viral, Human

Liver Diseases

Digestive System Diseases

Flaviviridae Infections

RNA Virus Infections

Virus Diseases

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.

Intervention code:

Nucleocapsid Proteins

Recombinant Proteins

Plasmids

Hepatitis C Antibodies

Immunotherapy, Active

Injections, Intramuscular

Viral Hepatitis Vaccines

Intervention keyword:

Terap C

Outcomes and Timepoint

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):

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.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

60 years

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Non-randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Zurina

Last Name:

Cinza Estevez

Specialty:

Specialist in Biochemistry

Affiliation:

Department of Clinical Trials, Vaccine Division, Biomedical Research, Center for Genetic Engineering and Biothecnology (CIGB).

Postal Address:

31st Ave. between 158 and 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2716022, ext 7227.

Email :

zurina.cinza@cigb.edu.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Santiago

Last Name:

Dueñas-Carrera

Affiliation:

Department of Clinical Trials, Vaccine Division, Biomedical Research, Center for Genetic Engineering and Biothecnology (CIGB).

Postal Address:

31st Ave. between 158 and 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2716022, ext 7265.

Email :

santiago.duenas@cigb.edu.cu [3]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000043

Date of Registration in Primary Registry:

2010-06-11

Record Verification Date:

2010-04-15 20:00

Link to the spanish version:

Click here [4]