Safety and Efficacy Study of CENV3 Vaccine to Protect Against HCV Infection (CENV3)
Recruitment status was: Recruiting
Description: A randomized Placebo-controlled study to evaluate safety and efficacy of Cenv3 peptide vaccine in normal volunteers. This study is designed to test safety of 3 consecutive monthly escalating doses of the immunogen ( 0.324 mg, 0.648 and 3.240 mg / 70 kgm body weight) in 40 healthy male subjects (15,15 and10 subjects respectively) plus 10 subjects on placebo. Bioavailability of Cenv3 will be tested throughout the duration of the experiment. In the study hyperimmune state will be achieved via 3 subcutaneous injections (0.648 mg each), once every 4 weeks. A placebo treated healthy subjects ( n= 10) will serve as controls. Chronic HCV patients ( n=50) who did not respond to IFN + RBV combined therapy will be recruited to test therapeutic efficacy of the compound via 6 consecutive injections ( 0.648 mg each ) every 2 weeks. ( NB : this group of patients has been already recruited in the first part of this project where evaluation of the compound is currently underway). Immunized healthy volunteers will be followed for a year compared with placebo group, where all biochemical, hematological, immunological and allergic parameters are recorded. Treated CHC patients will be evaluated for virological, hematological, biochemical and immunological states at the end of treatment.
Subject : Cenv3 potential prophylactic and therapeutic immunogens in healthy volunteers and against chronic HCV infection respectively.
|Vaccine Overdose of Undetermined Intent||Biological: prophylactic peptide vaccine Biological: therapeutic peptide vaccine||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||Safety and Efficacy of a Novel Candidate Peptide Vaccine Against HCV Infection in Healthy Volunteers and in Treated (Non-responders/ Responders) Chronic HCV Patients. Clinical Trials Phases I and II|
- Safety and Efficacy Study of CENV3 Vaccine to Protect Against HCV Infection [ Time Frame: two years ]
production of peptide vaccine to Protect Against HCV Infection Injection site reactions will be evaluated immediately and 1 h after each vaccination and at subsequent visits, and will be recorded as AE, if they occurred more than 1 h after injection.
Efficacy of vaccine will be measured via assessment of humoral Ab responses to vaccine epitopes in both groups of subjects.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Active Comparator: prophylactic vaccine
6 monthly doses each of 648 ug of prophylactic vaccine subcutaneously injected to healthy volunteers
Biological: prophylactic peptide vaccine
synthetic peptide vaccine derived from HCV E1 and HCV E2 will be used for immunization of healthy volunteers
Other Name: synthetic peptide vaccine derived from HCV E1 and HCV E2
Active Comparator: therapeutic vaccine
6 monthly doses each of 648 ug subcutaneously injected to chronic HCV patients
Biological: therapeutic peptide vaccine
therapeutic peptide vaccine will immunize to HCV chronic HCV patients non responders to INF
Other Name: CENV3 peptide vaccine
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01718834
|National Liver Institute, Menofyia University||Recruiting|
|Shebin El kom, Menofia, Egypt|
|Contact: Mostafa El-Awady firstname.lastname@example.org|
|Sub-Investigator: Mohamed ElGendy, MD|
|Principal Investigator:||Mostafa K. El Awady, Professor||National Research Center|