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

Search all trials

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

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.

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 group	Role	What they receive
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 Receives: Biological: AdCh3NSmut; Biological: 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 Receives: Biological: AdCh3NSmut; Biological: 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 Receives: Biological: AdCh3NSmut; Biological: 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 Receives: Biological: AdCh3NSmut; Biological: 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 Receives: Biological: AdCh3NSmut; Biological: 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 Receives: Biological: AdCh3NSmut; Biological: 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 Receives: Biological: AdCh3NSmut; Biological: 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 Receives: Biological: AdCh3NSmut; Biological: 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 Receives: Biological: AdCh3NSmut; Biological: Ad6NSmut

What is being measured

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

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.

Nov 2009Apr 2013

First posted29 Mar 2010 (estimated)
Study startNov 2009
Primary completionApr 2013
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatitis CStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study to Assess the Safety and Immunogenicity of Ad6NSmut and AdCh3NSmut in Patients With Hepatitis C Virus Infection
ClinicalTrials.gov ID: NCT01094873
Acronym / sponsor ID: HCV002TV
Conditions: Hepatitis C
Keywords: Hepatitis C, HCV, Adenovirus, Vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: ReiThera SrlIndustry (pharma, biotech, devices)
Collaborators: University of Oxford
Study start: Nov 2009
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 29 Mar 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Arm A, group 1	Experimental	Biological: AdCh3NSmut, Biological: Ad6NSmutInterventions: 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
Arm A, group 2	Experimental	Biological: AdCh3NSmut, Biological: Ad6NSmutInterventions: 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
Arm A, group 3	Experimental	Biological: AdCh3NSmut, Biological: Ad6NSmutInterventions: 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
Arm A, group 4	Experimental	Biological: AdCh3NSmut, Biological: Ad6NSmutInterventions: 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
Arm A, group 5	Experimental	Biological: AdCh3NSmut, Biological: Ad6NSmutInterventions: 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
Arm A, group 6	Experimental	Biological: AdCh3NSmut, Biological: Ad6NSmutInterventions: 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
Arm B, group 1	Experimental	Biological: AdCh3NSmut, Biological: Ad6NSmutInterventions: 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
Arm B, group 2	Experimental	Biological: AdCh3NSmut, Biological: Ad6NSmutInterventions: 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
Arm B, group 3	Experimental	Biological: AdCh3NSmut, Biological: Ad6NSmutInterventions: 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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (24 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AdCh3NSmutGenetic vaccines against Hepatitis C virus infection	Biological	Arm A, group 1, Arm A, group 2, Arm A, group 3, Arm A, group 4, Arm A, group 5, Arm A, group 6, Arm B, group 1, Arm B, group 2, Arm B, group 3
Ad6NSmutGenetic vaccine against Hepatitis C virus infection	Biological	Arm A, group 1, Arm A, group 2, Arm A, group 3, Arm A, group 4, Arm A, group 5, Arm A, group 6, Arm B, group 1, Arm B, group 2, Arm B, group 3

Primary outcome

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.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
HCV002TV study sponsor Web siteLink provided by the sponsor.

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eleanor Barnes, MD study chair

University of Oxford, UK

David Mutimer, Dr. principal investigator

University of Birmingham

2 sites in 1 country: see every site and its status.

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.