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Hepatitis CPhase 1NCT01094873

Study of a Novel Therapeutic Vaccine for Hepatitis C Virus

A Phase 1 study testing AdCh3NSmut and Ad6NSmut in people with Hepatitis C, run by ReiThera Srl at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C
What is being tested?
AdCh3NSmut and Ad6NSmut
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
2 sitesUnited Kingdom
Study dates
Nov 2009to Apr 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

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

    Birmingham, West Midlands, B15 2TH

  • John Radcliffe Hospital, Headley Way

    Headington, Oxford, OX3 9DU

Other trials in United Kingdom

About this study

Official title: A Phase I Study to Assess the Safety and Immunogenicity of Ad6NSmut and AdCh3NSmut in Patients With Hepatitis C Virus Infection

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.

Read more

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.
Conditions
Hepatitis C
Being tested
AdCh3NSmut, Ad6NSmut
Keywords
Hepatitis C, HCV, Adenovirus, Vaccine
Medical subject headings
Hepatitis C, Adenoviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdCh3NSmutBiological

    Genetic vaccines against Hepatitis C virus infection

  • Ad6NSmutBiological

    Genetic vaccine against Hepatitis C virus infection

Study groups in NCT01094873
Study groupRoleWhat they receive
Arm A, group 1ExperimentalInterventions: 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
Receives: Biological: AdCh3NSmut; Biological: Ad6NSmut
Arm A, group 2ExperimentalInterventions: 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
Receives: Biological: AdCh3NSmut; Biological: Ad6NSmut
Arm A, group 3ExperimentalInterventions: 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
Receives: Biological: AdCh3NSmut; Biological: Ad6NSmut
Arm A, group 4ExperimentalInterventions: 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
Receives: Biological: AdCh3NSmut; Biological: Ad6NSmut
Arm A, group 5ExperimentalInterventions: 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
Receives: Biological: AdCh3NSmut; Biological: Ad6NSmut
Arm A, group 6ExperimentalInterventions: 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
Receives: Biological: AdCh3NSmut; Biological: Ad6NSmut
Arm B, group 1ExperimentalInterventions: 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
Receives: Biological: AdCh3NSmut; Biological: Ad6NSmut
Arm B, group 2ExperimentalInterventions: 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
Receives: Biological: AdCh3NSmut; Biological: Ad6NSmut
Arm B, group 3ExperimentalInterventions: 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
Receives: Biological: AdCh3NSmut; Biological: Ad6NSmut

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2010 (estimated)
  2. Study startNov 2009
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01094873
Sponsor's protocol ID
HCV002TV
Other IDs
2008-006127-32, GTAC162, 2008
Status last verified
Aug 2013
First submitted
25 Mar 2010
Last updated
23 Apr 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AdCh3NSmut and Ad6NSmut in people with Hepatitis C, run by ReiThera Srl at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01094873.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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