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

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.

Timeline

Start

2011-03

Primary completion

2013-03

Completion

2013-03

Publications

• Background 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.

Drugs

Indications

No indication recorded.