Vaccine Overdose of Undetermined Intent | Safety and Efficacy Study of CENV3 Vaccine to Protect Against HCV Infection
Vaccine Overdose of Undetermined Intent research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Vaccine Overdose of Undetermined Intent
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Biological:prophylactic peptide vaccinesynthetic peptide vaccine derived from HCV E1 and HCV E2 will be used for immunization of healthy volunteers
Biological:therapeutic peptide vaccinetherapeutic peptide vaccine will immunize to HCV chronic HCV patients non responders to INF
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
prophylactic vaccine6 monthly doses each of 648 ug of prophylactic vaccine subcutaneously injected to healthy volunteers
therapeutic vaccine6 monthly doses each of 648 ug subcutaneously injected to chronic HCV patients
Start Date: March 2011
Completed Date: March 2013
Phase: Phase 1/Phase 2
Primary Outcome: Safety and Efficacy Study of CENV3 Vaccine to Protect Against HCV Infection
Study sponsors, principal investigator, and references
Principal Investigator: Mostafa K. El Awady, Professor
Lead Sponsor: National Liver Institute, Egypt
El-Awady MK, Tabll AA, Yousif H, El-Abd Y, Reda M, Khalil SB, El-Zayadi AR, Shaker MH, Bader El Din NG. Murine neutralizing antibody response and toxicity to synthetic peptides derived from E1 and E2 proteins of hepatitis C virus. Vaccine. 2010 Dec 6;28(52):8338-44. doi: 10.1016/j.vaccine.2009.11.059. Epub 2009 Dec 6.