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Trial record 35 of 7102 for:    vaccination

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

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ClinicalTrials.gov Identifier: NCT01718834
Recruitment Status : Unknown
Verified October 2012 by Mostafa K. El Awady, National Liver Institute, Egypt.
Recruitment status was:  Recruiting
First Posted : October 31, 2012
Last Update Posted : October 31, 2012
Sponsor:
Information provided by (Responsible Party):
Mostafa K. El Awady, National Liver Institute, Egypt

Brief Summary:

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 or disease Intervention/treatment Phase
Vaccine Overdose of Undetermined Intent Biological: prophylactic peptide vaccine Biological: therapeutic peptide vaccine Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (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
Study Start Date : March 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: October 31, 2012
Last Verified: October 2012

Keywords provided by Mostafa K. El Awady, National Liver Institute, Egypt:
prophylactic vaccine
chronic HCV patients
healthy risk volunteers

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs