Safety and Efficacy Study of CENV3 Vaccine to Protect Against HCV Infection
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vaccine Overdose of Undetermined Intent |
Biological: prophylactic peptide vaccine Biological: therapeutic peptide vaccine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study 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 ] [ Designated as safety issue: Yes ]
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.
| Estimated Enrollment: | 50 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy volunteers including subjects from both sexes,
- 18-55 years of age will be enrolled.
All subjects had to fulfill all inclusion criteria as follows:
- mentally and physically healthy,
- no clinically relevant pathological findings in any of the investigations of the pre-study examination including blood chemistry (liver and kidney function tests),
- differential blood counts,
- coagulation test,
- ultrasensitive C-reactive protein levels. Subjects should be able to provide written informed consents.
Exclusion Criteria:
- pregnant or breast feeding women,
- patients with chronic viral-infections (e.g., HBV, HCV, HIV), evidence of decompensated liver disease, pre-existing hematuria, or proteinuria,
- cryoglobulin levels > 1% or other immunologically driven diseases,
- schistosomiasis,
- acute infectious illness,
- severe psychiatric disorders,
- current or past history of malignancy and patients who received treatment with interferon or any investigational therapy for hepatitis during the 3 months prior to study entry.
Contacts and Locations| Egypt | |
| National Liver Institute, Menofyia University | Recruiting |
| Shebin El kom, Menofia, Egypt | |
| Contact: Mostafa El-Awady mkawady@yahoo.com | |
| Sub-Investigator: Mohamed ElGendy, MD | |
| Principal Investigator: | Mostafa K. El Awady, Professor | National Research Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Mostafa K. El Awady, Professor, National Liver Institute, Egypt |
| ClinicalTrials.gov Identifier: | NCT01718834 History of Changes |
| Other Study ID Numbers: | NRC |
| Study First Received: | June 27, 2012 |
| Last Updated: | October 30, 2012 |
| Health Authority: | Egypt: Institutional Review Board |
Keywords provided by National Liver Institute, Egypt:
|
prophylactic vaccine chronic HCV patients healthy risk volunteers |
Additional relevant MeSH terms:
|
Overdose Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 21, 2013