NCT01094873

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2009

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 23, 2015

Status Verified

August 1, 2013

Enrollment Period

3.4 years

First QC Date

March 25, 2010

Last Update Submit

April 22, 2015

Conditions

Hepatitis C

Keywords

Hepatitis CHCVAdenovirusVaccine

Outcome Measures

Primary Outcomes (1)

  • Safety and immunogenicity

    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.

    Different time points depending on the study groups with a 6-months follow-up after last vaccination for all groups

Study Arms (9)

Arm A, group 1

EXPERIMENTAL

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

Biological: AdCh3NSmutBiological: Ad6NSmut

Arm A, group 2

EXPERIMENTAL

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

Biological: AdCh3NSmutBiological: Ad6NSmut

Arm A, group 3

EXPERIMENTAL

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

Biological: AdCh3NSmutBiological: Ad6NSmut

Arm A, group 4

EXPERIMENTAL

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

Biological: AdCh3NSmutBiological: Ad6NSmut

Arm A, group 5

EXPERIMENTAL

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

Biological: AdCh3NSmutBiological: Ad6NSmut

Arm A, group 6

EXPERIMENTAL

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

Biological: AdCh3NSmutBiological: Ad6NSmut

Arm B, group 1

EXPERIMENTAL

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

Biological: AdCh3NSmutBiological: Ad6NSmut

Arm B, group 2

EXPERIMENTAL

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

Biological: AdCh3NSmutBiological: Ad6NSmut

Arm B, group 3

EXPERIMENTAL

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

Biological: AdCh3NSmutBiological: Ad6NSmut

Interventions

AdCh3NSmutBIOLOGICAL

Genetic vaccines against Hepatitis C virus infection

Arm A, group 1Arm A, group 2Arm A, group 3Arm A, group 4Arm A, group 5Arm A, group 6Arm B, group 1Arm B, group 2Arm B, group 3
Ad6NSmutBIOLOGICAL

Genetic vaccine against Hepatitis C virus infection

Arm A, group 1Arm A, group 2Arm A, group 3Arm A, group 4Arm A, group 5Arm A, group 6Arm B, group 1Arm B, group 2Arm B, group 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wellcome Clinical Research Facility, Queen Elizabeth's Hospital, University Hospital Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

John Radcliffe Hospital, Headley Way

Headington, Oxford, OX3 9DU, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Hepatitis CAdenoviridae Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesDNA Virus Infections

Study Officials

  • Eleanor Barnes, MD

    University of Oxford, UK

    STUDY CHAIR

  • David Mutimer, Dr.

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 29, 2010

Study Start

November 1, 2009

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 23, 2015

Record last verified: 2013-08

Locations

GB(2)