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Study of a Novel Therapeutic Vaccine for Hepatitis C Virus

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ClinicalTrials.gov Identifier: NCT01094873
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : April 23, 2015
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
ReiThera Srl

Tracking Information
First Submitted Date  ICMJE March 25, 2010
First Posted Date  ICMJE March 29, 2010
Last Update Posted Date April 23, 2015
Study Start Date  ICMJE November 2009
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
Safety and immunogenicity [ Time Frame: Different time points depending on the study groups with a 6-months follow-up after last vaccination for all groups ]
To assess the safety and immunogenicity of new hepatitis C vaccine candidates, AdCh3NSmut and Ad6NSmut when administered in a prime/boost regimen to HCV infected patients. The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. The specific endpoint of cellular immune response will be collected via IFN-gamma ELISpot assay and other exploratory immunological tests.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01094873 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Novel Therapeutic Vaccine for Hepatitis C Virus
Official Title  ICMJE A Phase I Study to Assess the Safety and Immunogenicity of Ad6NSmut and AdCh3NSmut in Patients With Hepatitis C Virus Infection
Brief Summary

HCV002TV is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine against Hepatitis C virus (HCV) in chronically infected patients. The vaccine is based on the sequential delivery, by intramuscular route, of two different adenoviral vectors, of chimpanzee and human origin respectively, bearing the same genetic information for HCV antigens (NS region).

The two recombinant vaccine vectors, called AdCh3NSmut and Ad6NSmut, are weakened and unable to multiply within the body; they are designed to induce an immune response against HCV proteins. AdCh3NSmut and Ad6NSmut are being used in the ongoing HCV001 study in healthy volunteers with very good safety and immunogenicity results.

HCV002TV is a dose-escalation study; the AdCh3NSmut is administered as priming vaccination and Ad6NSmut as boosting vaccination.

The trial includes:

  • Arm A, in which vaccinated patients are into Interferon-ribavirin therapy (the gold standard therapy for hepatitis C);
  • Arm B, in which vaccinated patients are not into therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Biological: AdCh3NSmut
    Genetic vaccines against Hepatitis C virus infection
  • Biological: Ad6NSmut
    Genetic vaccine against Hepatitis C virus infection
Study Arms  ICMJE
  • Experimental: Arm A, group 1

    Interventions: AdCh3NSmut; Ad6NSmut. Administration schedule: 1 dose AdCh3NSmut 5 x 10^8vp at week 14 and 1 dose Ad6NSmut 5 x 10^8vp at week 24, after starting PEG-IFN and ribavirin therapy.

    Patients: 2

    Interventions:
    • Biological: AdCh3NSmut
    • Biological: Ad6NSmut
  • Experimental: Arm A, group 2

    Interventions: AdCh3NSmut; Ad6NSmut. Administration schedule: 1 dose AdCh3NSmut 5 x 10^9vp at week 14 and 1 dose Ad6NSmut 5 x 10^9vp at week 24, after starting PEG-IFN and ribavirin therapy.

    Patients: 2

    Interventions:
    • Biological: AdCh3NSmut
    • Biological: Ad6NSmut
  • Experimental: Arm A, group 3

    Interventions: AdCh3NSmut; Ad6NSmut. Administration schedule: 1 dose AdCh3NSmut 2.5 x 10^10vp at week 14 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24, after starting PEG-IFN and ribavirin therapy.

    Patients: 6

    Interventions:
    • Biological: AdCh3NSmut
    • Biological: Ad6NSmut
  • Experimental: Arm A, group 4

    Interventions: AdCh3NSmut; Ad6NSmut. Administration schedule: 1 dose AdCh3NSmut 2.5 x 10^10vp at week 2 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 12, after starting PEG-IFN and ribavirin therapy.

    Patients: 6

    Interventions:
    • Biological: AdCh3NSmut
    • Biological: Ad6NSmut
  • Experimental: Arm A, group 5

    Interventions: AdCh3NSmut; Ad6NSmut. Administration schedule: 1 dose AdCh3NSmut 2.5 x 10^10vp at weeks 14 and 18, and 1 dose Ad6NSmut 2.5 x 10^10vp at week 28, after starting PEG-IFN and ribavirin therapy.

    Patients: 4

    Interventions:
    • Biological: AdCh3NSmut
    • Biological: Ad6NSmut
  • Experimental: Arm A, group 6

    Interventions: AdCh3NSmut; Ad6NSmut. Administration schedule: 1 dose AdCh3NSmut 2.5 x 10^10vp at weeks 2 and 6, and 1 dose Ad6NSmut 2.5 x 10^10vp at week 16, after starting PEG-IFN and ribavirin therapy.

    Patients: 4

    Interventions:
    • Biological: AdCh3NSmut
    • Biological: Ad6NSmut
  • Experimental: Arm B, group 1

    Interventions: AdCh3NSmut; Ad6NSmut. Administration schedule: 1 dose AdCh3NSmut 5 x 10^8vp at week 4 and 1 dose Ad6NSmut 5 x 10^8vp at week 14.

    Patients: 2

    Interventions:
    • Biological: AdCh3NSmut
    • Biological: Ad6NSmut
  • Experimental: Arm B, group 2

    Interventions: AdCh3NSmut; Ad6NSmut. Administration schedule: 1 dose AdCh3NSmut 5 x 10^9vp at week 4 and 1 dose Ad6NSmut 5 x 10^9vp at week 14.

    Patients: 2

    Interventions:
    • Biological: AdCh3NSmut
    • Biological: Ad6NSmut
  • Experimental: Arm B, group 3

    Interventions: AdCh3NSmut; Ad6NSmut.

    1 dose AdCh3NSmut 2.5 x 10^10vp at week 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 14.

    Patients: 4

    Interventions:
    • Biological: AdCh3NSmut
    • Biological: Ad6NSmut
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2015)
35
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2010)
24
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient must satisfy all the following criteria to be eligible for the study:

    • HCV infected with genotype-1 infection
    • Adults aged 18 to 65 years (inclusive)
    • In arms A1-A3 patients will only be vaccinated if they have a >2log drop in viral load at week 12 of IFN-alpha and ribavirin therapy. Vaccination will then occur at week 14 into IFN-alpha and ribavirin therapy.
    • Resident in or near the trial sites for the duration of the vaccination study
    • Able and willing (in the Investigator's opinion) to comply with all study requirements
    • For women of child bearing potential, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of vaccination
    • For men to use barrier contraception until three months after the last vaccination
    • Written informed consent

Exclusion Criteria:

  • The patient may not enter the study if any of the following apply:

    • Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
    • Prior receipt of a recombinant simian or human adenoviral vaccine
    • Clinical, biochemical, ultrasonographic, or liver biopsy (histology) evidence of cirrhosis or portal hypertension
    • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
    • Patients likely to have been infected with HCV within the last 12 months
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g., Kathon
    • Patients who failed to respond (non-responders) to previous IFN-alpha monotherapy
    • Patients who received IFN-alpha and ribavirin in the past and who were non-responders or relapsed during or after therapy
    • History of clinically significant contact dermatitis
    • For Arm A, patients must be treatment naïve (i.e. never have had previous IFNα or ribavirin treatment). Arm B may include patients who have previously been treated for HCV and failed to achieve a sustained virological response (defined by undetectable HCV by PCR at 6 months post cessation of treatment)
    • Any history of anaphylaxis in reaction to vaccination
    • Pregnancy, lactation or willingness/intention to become pregnant during the study
    • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
    • Any other serious chronic illness requiring hospital specialist supervision
    • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
    • Current suspected or known injecting drug abuse
    • Seropositive for hepatitis B surface antigen (HBsAg)
    • Seropositive for HIV (antibodies to HIV) at screening
    • Seropositive for simian adenovirus 3 (antibodies to AdCh3) at titres >200, at screening
    • Seropositive for human adenovirus 6 (antibodies to Ad6) at titres >200, at screening
    • Any other significant disease, disorder or finding, which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or may influence the result of the study, or the patient's ability to participate in the study
    • Any other finding which in the opinion of the investigators would significantly increase the risk of having an adverse outcome from participating in the protocol
    • Individuals who have had a temperature >38°C in the 3 days preceding vaccination.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01094873
Other Study ID Numbers  ICMJE HCV002TV
2008-006127-32 ( EudraCT Number )
GTAC162 ( Other Identifier: Gene Therapy Advisory Committee (GTAC), UK )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ReiThera Srl
Study Sponsor  ICMJE ReiThera Srl
Collaborators  ICMJE University of Oxford
Investigators  ICMJE
Study Chair: Eleanor Barnes, MD University of Oxford, UK
Principal Investigator: David Mutimer, Dr. University of Birmingham
PRS Account ReiThera Srl
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP