<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01718834</url>
  </required_header>
  <id_info>
    <org_study_id>NRC</org_study_id>
    <nct_id>NCT01718834</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of CENV3 Vaccine to Protect Against HCV Infection</brief_title>
  <acronym>CENV3</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Liver Institute, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Liver Institute, Egypt</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Description: A randomized Placebo-controlled study to evaluate safety and efficacy of Cenv3&#xD;
      peptide vaccine in normal volunteers. This study is designed to test safety of 3 consecutive&#xD;
      monthly escalating doses of the immunogen ( 0.324 mg, 0.648 and 3.240 mg / 70 kgm body&#xD;
      weight) in 40 healthy male subjects (15,15 and10 subjects respectively) plus 10 subjects on&#xD;
      placebo. Bioavailability of Cenv3 will be tested throughout the duration of the experiment.&#xD;
      In the study hyperimmune state will be achieved via 3 subcutaneous injections (0.648 mg&#xD;
      each), once every 4 weeks. A placebo treated healthy subjects ( n= 10) will serve as&#xD;
      controls. Chronic HCV patients ( n=50) who did not respond to IFN + RBV combined therapy will&#xD;
      be recruited to test therapeutic efficacy of the compound via 6 consecutive injections (&#xD;
      0.648 mg each ) every 2 weeks. ( NB : this group of patients has been already recruited in&#xD;
      the first part of this project where evaluation of the compound is currently underway).&#xD;
      Immunized healthy volunteers will be followed for a year compared with placebo group, where&#xD;
      all biochemical, hematological, immunological and allergic parameters are recorded. Treated&#xD;
      CHC patients will be evaluated for virological, hematological, biochemical and immunological&#xD;
      states at the end of treatment.&#xD;
&#xD;
      Subject : Cenv3 potential prophylactic and therapeutic immunogens in healthy volunteers and&#xD;
      against chronic HCV infection respectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the present work, we plan to study the safety and efficacy of a peptide vaccine termed&#xD;
      Cenv3 ( C for HCV, en for envelop, v for vaccine, 3 for 3 epitopes). The main outlines of the&#xD;
      current study include: 1) Examining the safety parameters throughout the vaccination period&#xD;
      including acute and chronic reactions if present in a phase 1 clinical study ( i.e. in&#xD;
      healthy volunteers). The vaccine will be administered sc at 3 escalating doses in presence&#xD;
      and absence of adjuvant. Bioavailability of the vaccine throughout the experiment duration&#xD;
      will also be determined. 2) Assessment of the humoral and cellular immune responses towards&#xD;
      Cenv3 in healthy volunteers ( higher risk for acquiring HCV infection). 3) Evaluation of the&#xD;
      neutralizing capacity of the generated Abs to interfere with intracellular replication of HCV&#xD;
      in permissive cell lines&#xD;
&#xD;
      ii) Objective The present proposal aims at:-&#xD;
&#xD;
        1. Examining safety and tolerability towards the candidate HCV peptide vaccine in healthy&#xD;
           volunteers.&#xD;
&#xD;
        2. Testing cell mediated immunity via cytotoxic T lymphocyte responses in vaccinated&#xD;
           healthy subjects ( CMI).&#xD;
&#xD;
        3. Determining epitope specific B cell response and antibody titers in vaccinated&#xD;
           individuals (humoral Immunogenicity).&#xD;
&#xD;
        4. Testing the viral neutralization by antibodies against the vaccine epitopes. (Efficacy).&#xD;
&#xD;
        5. Studying the bioavailability of the peptides in subjects' circulation throughout the&#xD;
           vaccination time and 90 days post vaccination.&#xD;
&#xD;
      iii) Study population&#xD;
&#xD;
      Subjects with any cardiovascular problems, asthma, or allergies, should be excluded from the&#xD;
      study. Also, any subject who has participated in any experimental medicine clinical trial in&#xD;
      the past 3 months will be excluded. Healthy volunteers including subjects from both sexes,&#xD;
      18-55 years of age will be enrolled. All subjects had to fulfill all inclusion criteria as&#xD;
      follows: mentally and physically healthy, no clinically relevant pathological findings in any&#xD;
      of the investigations of the pre-study examination including blood chemistry ( liver and&#xD;
      kidney function tests), differential blood counts, coagulation test, ultrasensitive&#xD;
      C-reactive protein levels. Subjects should be able to provide written informed consents. The&#xD;
      exclusion criteria included pregnant or breast feeding women, patients with chronic&#xD;
      viral-infections (e.g., HBV, HCV, HIV, CMV, HSV), evidence of decompensated liver disease,&#xD;
      pre-existing hematuria, or proteinuria, cryoglobulin levels &gt;1% or other immunologically&#xD;
      driven diseases, schistosomiasis, acute infectious illness, severe psychiatric disorders,&#xD;
      current or past history of malignancy and patients who received treatment with interferon or&#xD;
      any investigational therapy for hepatitis during the 3 months prior to study entry.&#xD;
&#xD;
      iv) Consent The volunteers will be provided with a written information sheet on the vaccine&#xD;
      and the requirements of this trial. They will&#xD;
&#xD;
      , in return, give written consent to participate in the study. Subjects will be paid an&#xD;
      honorarium for their participation. They will also be provided with transport money to and&#xD;
      from the hospital.&#xD;
&#xD;
      v) Outlines of the study : In the proposed study, we aim at evaluating tolerability, safety,&#xD;
      immunogenicity and efficacy of Cenv3 peptide vaccine in 112 healthy volunteers as a placebo&#xD;
      controlled open labeled phase 1 clinical trial. Tolerability and safety parameters include&#xD;
      clinical signs ( acute and chronic), biochemical assays ( hepatic and renal functions as well&#xD;
      as other metabolic parameters) and hematological tests ( all blood cell parameters). Both&#xD;
      humoral and cellular responses to the immunization protocols will be evaluated. Neutralizing&#xD;
      capacities of specific Abs generated in response to the vaccine will also be determined after&#xD;
      vaccination.&#xD;
&#xD;
      vi) Vaccination&#xD;
&#xD;
      Preparation of vaccine will be performed under the principles of Good Manufacturing Practice.&#xD;
      The lyophilized peptides are manufactured in an eight arm multiple antigenic peptide (MAP) in&#xD;
      a commercial facility specialized in peptide synthesis and structure modification ( .e.g&#xD;
      AnaSpec USA). Peptides will be dissolved in PBS made for human use. The whole procedure will&#xD;
      be done in sterilized areas of drug/vaccine industry ( e.g. VACSERA, MOH Wezaret Al Zera'a&#xD;
      street Agouza). The lyophilized peptides will be stored in regular fridge, while dissolved&#xD;
      peptides will be stored at -80 0 C as aliquots ( in sealed ampoules each contains 1X dose)&#xD;
      ready for injection and transported to the hospital in dry ice just before use. Note : These&#xD;
      storage and transportation precautions are followed during these early stages of the study.&#xD;
      While the strategy would be modified at a commercial scale when the current product proves&#xD;
      effective. In this later case a lyophilized powder with the recommended dose will be packaged&#xD;
      in a sealed ampoules and dissolved just before use. HCV peptide vaccine Cenv3 will be&#xD;
      injected subcutaneously in 3 different doses ( 1x i.e. 324 ug , 2x i.e. 648 ug or 3x 1296 ug/&#xD;
      70 kgm body weight adult). It should be noted here, that dose 1X equals to the calculated&#xD;
      pharmaceutical dose from mice experiments, therefore 324 ug/ 70 kg body weight is the Minimum&#xD;
      Available Biologically Effective dose Level (MABEL). Based on other laboratories experience&#xD;
      with peptide vaccine administration to man ( Tanaka and Manns) who used up to 5000 ug of&#xD;
      peptide vaccine for their immunization experiments. The highest dose used in our protocol is&#xD;
      4X ( 1296 ug/ 70 kg bw) and therefore considered the No Observable Adverse Effect Level (&#xD;
      NOAEL) in this protocol. The vaccine will be administered either as a MAP form ( self&#xD;
      adjuvanted) or supplemented with adjuvant ( MF59) in a common protocol of monthly injection&#xD;
      for 3 consecutive months.&#xD;
&#xD;
      vii) Sample collection&#xD;
&#xD;
      All immunization and sampling procedures will be performed in Ahmed Maher Educational&#xD;
      Hospital ( MOH). Subject enrollment, consenting, vaccination, sampling and clinical&#xD;
      observation post vaccination will be done under close medical supervision by trained&#xD;
      clinicians in the hospital. Seven blood samples will be taken from subjects prior to the&#xD;
      first immunization and at days 30, 60, 90 ( during vaccination period) and days 135, 180 and&#xD;
      360 thereafter. At day 360 subjects will be immunized with a booster dose equal to the&#xD;
      original dose given to the same subject and an 8th blood sample will be collected 30 days&#xD;
      after the booster dose. Each time 15 ml venous blood will be withdrawn. Eight ml will be used&#xD;
      for serum separation for humoral response determination, neutralization assays and&#xD;
      biochemical testing. Seven ml on EDTA for CBC and lymphocyte separation for EliSpot assay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2011</start_date>
  <completion_date type="Anticipated">March 2013</completion_date>
  <primary_completion_date type="Anticipated">March 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and Efficacy Study of CENV3 Vaccine to Protect Against HCV Infection</measure>
    <time_frame>two years</time_frame>
    <description>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.&#xD;
Efficacy of vaccine will be measured via assessment of humoral Ab responses to vaccine epitopes in both groups of subjects.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Vaccine Overdose of Undetermined Intent</condition>
  <arm_group>
    <arm_group_label>prophylactic vaccine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>6 monthly doses each of 648 ug of prophylactic vaccine subcutaneously injected to healthy volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>therapeutic vaccine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>6 monthly doses each of 648 ug subcutaneously injected to chronic HCV patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>prophylactic peptide vaccine</intervention_name>
    <description>synthetic peptide vaccine derived from HCV E1 and HCV E2 will be used for immunization of healthy volunteers</description>
    <arm_group_label>prophylactic vaccine</arm_group_label>
    <other_name>synthetic peptide vaccine derived from HCV E1 and HCV E2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>therapeutic peptide vaccine</intervention_name>
    <description>therapeutic peptide vaccine will immunize to HCV chronic HCV patients non responders to INF</description>
    <arm_group_label>therapeutic vaccine</arm_group_label>
    <other_name>CENV3 peptide vaccine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers including subjects from both sexes,&#xD;
&#xD;
          -  18-55 years of age will be enrolled.&#xD;
&#xD;
        All subjects had to fulfill all inclusion criteria as follows:&#xD;
&#xD;
          -  mentally and physically healthy,&#xD;
&#xD;
          -  no clinically relevant pathological findings in any of the investigations of the&#xD;
             pre-study examination including blood chemistry (liver and kidney function tests),&#xD;
&#xD;
          -  differential blood counts,&#xD;
&#xD;
          -  coagulation test,&#xD;
&#xD;
          -  ultrasensitive C-reactive protein levels. Subjects should be able to provide written&#xD;
             informed consents.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or breast feeding women,&#xD;
&#xD;
          -  patients with chronic viral-infections (e.g., HBV, HCV, HIV), evidence of&#xD;
             decompensated liver disease, pre-existing hematuria, or proteinuria,&#xD;
&#xD;
          -  cryoglobulin levels &gt; 1% or other immunologically driven diseases,&#xD;
&#xD;
          -  schistosomiasis,&#xD;
&#xD;
          -  acute infectious illness,&#xD;
&#xD;
          -  severe psychiatric disorders,&#xD;
&#xD;
          -  current or past history of malignancy and patients who received treatment with&#xD;
             interferon or any investigational therapy for hepatitis during the 3 months prior to&#xD;
             study entry.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mostafa K. El Awady, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Liver Institute, Menofyia University</name>
      <address>
        <city>Shebin El kom</city>
        <state>Menofia</state>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mostafa El-Awady</last_name>
      <email>mkawady@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Mohamed ElGendy, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://www.liver-eg.org/</url>
    <description>National Liver Institute, Shebin El kom, Egypt</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>19995542</PMID>
  </reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>June 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>October 30, 2012</last_update_submitted>
  <last_update_submitted_qc>October 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Liver Institute, Egypt</investigator_affiliation>
    <investigator_full_name>Mostafa K. El Awady</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>prophylactic vaccine</keyword>
  <keyword>chronic HCV patients</keyword>
  <keyword>healthy risk volunteers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01718834
org study id: NRC
nct id: NCT01718834
lead sponsor: 
has dmc: Yes
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.
In the present work, we plan to study the safety and efficacy of a peptide vaccine termed
      Cenv3 ( C for HCV, en for envelop, v for vaccine, 3 for 3 epitopes). The main outlines of the
      current study include: 1) Examining the safety parameters throughout the vaccination period
      including acute and chronic reactions if present in a phase 1 clinical study ( i.e. in
      healthy volunteers). The vaccine will be administered sc at 3 escalating doses in presence
      and absence of adjuvant. Bioavailability of the vaccine throughout the experiment duration
      will also be determined. 2) Assessment of the humoral and cellular immune responses towards
      Cenv3 in healthy volunteers ( higher risk for acquiring HCV infection). 3) Evaluation of the
      neutralizing capacity of the generated Abs to interfere with intracellular replication of HCV
      in permissive cell lines

      ii) Objective The present proposal aims at:-

        1. Examining safety and tolerability towards the candidate HCV peptide vaccine in healthy
           volunteers.

        2. Testing cell mediated immunity via cytotoxic T lymphocyte responses in vaccinated
           healthy subjects ( CMI).

        3. Determining epitope specific B cell response and antibody titers in vaccinated
           individuals (humoral Immunogenicity).

        4. Testing the viral neutralization by antibodies against the vaccine epitopes. (Efficacy).

        5. Studying the bioavailability of the peptides in subjects' circulation throughout the
           vaccination time and 90 days post vaccination.

      iii) Study population

      Subjects with any cardiovascular problems, asthma, or allergies, should be excluded from the
      study. Also, any subject who has participated in any experimental medicine clinical trial in
      the past 3 months will be excluded. 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. The
      exclusion criteria included pregnant or breast feeding women, patients with chronic
      viral-infections (e.g., HBV, HCV, HIV, CMV, HSV), 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.

      iv) Consent The volunteers will be provided with a written information sheet on the vaccine
      and the requirements of this trial. They will

      , in return, give written consent to participate in the study. Subjects will be paid an
      honorarium for their participation. They will also be provided with transport money to and
      from the hospital.

      v) Outlines of the study : In the proposed study, we aim at evaluating tolerability, safety,
      immunogenicity and efficacy of Cenv3 peptide vaccine in 112 healthy volunteers as a placebo
      controlled open labeled phase 1 clinical trial. Tolerability and safety parameters include
      clinical signs ( acute and chronic), biochemical assays ( hepatic and renal functions as well
      as other metabolic parameters) and hematological tests ( all blood cell parameters). Both
      humoral and cellular responses to the immunization protocols will be evaluated. Neutralizing
      capacities of specific Abs generated in response to the vaccine will also be determined after
      vaccination.

      vi) Vaccination

      Preparation of vaccine will be performed under the principles of Good Manufacturing Practice.
      The lyophilized peptides are manufactured in an eight arm multiple antigenic peptide (MAP) in
      a commercial facility specialized in peptide synthesis and structure modification ( .e.g
      AnaSpec USA). Peptides will be dissolved in PBS made for human use. The whole procedure will
      be done in sterilized areas of drug/vaccine industry ( e.g. VACSERA, MOH Wezaret Al Zera'a
      street Agouza). The lyophilized peptides will be stored in regular fridge, while dissolved
      peptides will be stored at -80 0 C as aliquots ( in sealed ampoules each contains 1X dose)
      ready for injection and transported to the hospital in dry ice just before use. Note : These
      storage and transportation precautions are followed during these early stages of the study.
      While the strategy would be modified at a commercial scale when the current product proves
      effective. In this later case a lyophilized powder with the recommended dose will be packaged
      in a sealed ampoules and dissolved just before use. HCV peptide vaccine Cenv3 will be
      injected subcutaneously in 3 different doses ( 1x i.e. 324 ug , 2x i.e. 648 ug or 3x 1296 ug/
      70 kgm body weight adult). It should be noted here, that dose 1X equals to the calculated
      pharmaceutical dose from mice experiments, therefore 324 ug/ 70 kg body weight is the Minimum
      Available Biologically Effective dose Level (MABEL). Based on other laboratories experience
      with peptide vaccine administration to man ( Tanaka and Manns) who used up to 5000 ug of
      peptide vaccine for their immunization experiments. The highest dose used in our protocol is
      4X ( 1296 ug/ 70 kg bw) and therefore considered the No Observable Adverse Effect Level (
      NOAEL) in this protocol. The vaccine will be administered either as a MAP form ( self
      adjuvanted) or supplemented with adjuvant ( MF59) in a common protocol of monthly injection
      for 3 consecutive months.

      vii) Sample collection

      All immunization and sampling procedures will be performed in Ahmed Maher Educational
      Hospital ( MOH). Subject enrollment, consenting, vaccination, sampling and clinical
      observation post vaccination will be done under close medical supervision by trained
      clinicians in the hospital. Seven blood samples will be taken from subjects prior to the
      first immunization and at days 30, 60, 90 ( during vaccination period) and days 135, 180 and
      360 thereafter. At day 360 subjects will be immunized with a booster dose equal to the
      original dose given to the same subject and an 8th blood sample will be collected 30 days
      after the booster dose. Each time 15 ml venous blood will be withdrawn. Eight ml will be used
      for serum separation for humoral response determination, neutralization assays and
      biochemical testing. Seven ml on EDTA for CBC and lymphocyte separation for EliSpot assay.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Safety and Efficacy Study of CENV3 Vaccine to Protect Against HCV Infection
time frame: two years
description: 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.
arm group label: prophylactic vaccine
arm group type: Active Comparator
description: 6 monthly doses each of 648 ug of prophylactic vaccine subcutaneously injected to healthy volunteers
arm group label: therapeutic vaccine
arm group type: Active Comparator
description: 6 monthly doses each of 648 ug subcutaneously injected to chronic HCV patients
intervention type: Biological
intervention name: prophylactic peptide vaccine
description: synthetic peptide vaccine derived from HCV E1 and HCV E2 will be used for immunization of healthy volunteers
arm group label: prophylactic vaccine
other name: synthetic peptide vaccine derived from HCV E1 and HCV E2
intervention type: Biological
intervention name: therapeutic peptide vaccine
description: therapeutic peptide vaccine will immunize to HCV chronic HCV patients non responders to INF
arm group label: therapeutic vaccine
other name: CENV3 peptide vaccine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mostafa K. El Awady, Professor
role: Principal Investigator
affiliation: National Research Center
facility: 
status: Recruiting
contact: 
investigator: 
country: Egypt
url: http://www.liver-eg.org/
description: National Liver Institute, Shebin El kom, Egypt
citation: 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.
PMID: 19995542
responsible party type: Principal Investigator
investigator affiliation: National Liver Institute, Egypt
investigator full name: Mostafa K. El Awady
investigator title: Professor
mesh term: Hepatitis C
mesh term: Vaccines