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Safety and Efficacy Study of CENV3 Vaccine to Protect Against HCV Infection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by National Liver Institute, Egypt.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mostafa K. El Awady, National Liver Institute, Egypt
ClinicalTrials.gov Identifier:
NCT01718834
First received: June 27, 2012
Last updated: October 30, 2012
Last verified: October 2012
  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

Further study details as provided by National Liver Institute, Egypt:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718834

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         
Sponsors and Collaborators
National Liver Institute, Egypt
Investigators
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

ClinicalTrials.gov processed this record on November 20, 2014