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Hepatitis CPhase 1NCT01070407

A Study of a New Candidate Vaccine Against Hepatitis C Virus (HCV)

A Phase 1 study testing Ad6NSmut; AdCh3NSmut and AdCh3NSmut; 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

HCV001 is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine against Hepatitis C virus (HCV). The vaccine is based on the sequential delivery, by intramuscular route, of two different adenoviral vectors, of human and chimpanzee origin respectively, bearing the same genetic information for… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis C
What is being tested?
Ad6NSmut; AdCh3NSmut and AdCh3NSmut; Ad6NSmut
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
2 sitesUnited Kingdom
Study dates
Jul 2007to Feb 2011
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The volunteer must satisfy all the following criteria to be eligible for the study:
  • Healthy adults aged 18 to 50 years (inclusive)
  • 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
  • Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
  • For females only, willingness to practice continuous effective barrier contraception during the study and a negative pregnancy test on the day(s) of vaccination
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  • For men to use barrier contraception until three months after the last vaccination
  • Agreement to refrain from blood donation during the course of the study
  • Written informed consent

Who cannot join

  • The volunteer 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
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
  • 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)
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g., Kathon
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  • History of clinically significant contact dermatitis
  • 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)
  • History of serious psychiatric condition
  • 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
  • Suspected or known injecting drug abuse
  • Seropositive for hepatitis B surface antigen (HBsAg)
  • Seropositive for HIV (antibodies to HIV) at screening
  • Seropositive for hepatitis C virus (antibodies to HCV) 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 volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate in the study
  • Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
  • 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.
  • Vulnerable subjects (according to the ICH E6 GCP)

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

  • Centre for Clinical Vaccinology and Tropical Medicine

    Oxford, Oxfordshire, OX3 7LJ

Other trials in United Kingdom

About this study

Official title: A Phase I Study to Assess the Safety and Immunogenicity of New Hepatitis C Virus Vaccine Candidates AdCh3NSmut and Ad6NSmut

HCV001 is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine against Hepatitis C virus (HCV). The vaccine is based on the sequential delivery, by intramuscular route, of two different adenoviral vectors, of human and chimpanzee origin respectively, bearing the same genetic information for HCV antigens (NS region).

The two recombinant vectors, called Ad6NSmut and AdCh3NSmut, are weakened and unable to multiply within the body; they are designed to induce an immune response against HCV proteins. Although Ad6NSmut and AdCh3NSmut have never been given to humans before this trial, promising results have been obtained in non-human studies.

The HCV001 study is designed to explore different prime-boost regimes concerning dose, order and interval of administration of Ad6NSmut and AdCh3NSmut.

Conditions
Hepatitis C
Being tested
Ad6NSmut; AdCh3NSmut, AdCh3NSmut; Ad6NSmut
Keywords
Hepatitis C virus, 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.

  • Ad6NSmut; AdCh3NSmutBiological

    2 doses Ad6NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.

  • Ad6NSmut; AdCh3NSmutBiological

    2 doses Ad6NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.

  • Ad6NSmut; AdCh3NSmutBiological

    2 doses Ad6NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.

  • AdCh3NSmut; Ad6NSmutBiological

    2 doses AdCh3NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.

  • AdCh3NSmut; Ad6NSmutBiological

    2 doses AdCh3NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.

  • AdCh3NSmut; Ad6NSmutBiological

    2 doses AdCh3NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.

  • Ad6NSmut; AdCh3NSmutBiological

    1 dose Ad6NSmut 2.5 x 10^10vp at week 0 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 8.

  • AdCh3NSmut; Ad6NSmutBiological

    1 dose AdCh3NSmut 2.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 8.

  • AdCh3NSmut; Ad6NSmutBiological

    1 dose AdCh3NSmut 7.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 7.5 x 10^10vp at week 8.

Study groups in NCT01070407
Study groupRoleWhat they receive
Arm A, group 1Experimental4 volunteers
Receives: Biological: Ad6NSmut; AdCh3NSmut
Arm A, group 2Experimental4 volunteers
Receives: Biological: Ad6NSmut; AdCh3NSmut
Arm A, group 3Experimental5 volunteers
Receives: Biological: Ad6NSmut; AdCh3NSmut
Arm B, group 5Experimental4 volunteers
Receives: Biological: AdCh3NSmut; Ad6NSmut
Arm B, group 6Experimental4 volunteers
Receives: Biological: AdCh3NSmut; Ad6NSmut
Arm B, group 7Experimental5 volunteers
Receives: Biological: AdCh3NSmut; Ad6NSmut
Arm C, group 9Experimental5 volunteers
Receives: Biological: Ad6NSmut; AdCh3NSmut
Arm C, group 10Experimental5 volunteers
Receives: Biological: AdCh3NSmut; Ad6NSmut
Arm C, group 11Experimental4 volunteers
Receives: Biological: AdCh3NSmut; Ad6NSmut

What is being measured

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

  1. To assess the safety of AdCh3NSmut and Ad6NSmut, when administered in a prime/boost regimen to healthy volunteers. The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.

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

Secondary outcomes (1)

  1. To assess the immunogenicity of AdCh3NSmut and Ad6NSmut, when administered in prime/boost regimen to healthy volunteers. The specific endpoint of cellular immune response will be collected via IFNγ 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 posted18 Feb 2010 (estimated)
  2. Study startJul 2007
  3. Primary completionAug 2010
  4. Study completionFeb 2011

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
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01070407
Sponsor's protocol ID
HCV001
Other IDs
2007-004259-12, GTAC144
Status last verified
Apr 2015
First submitted
16 Feb 2010
Last updated
23 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Alsaleh G, Panse I, Swadling L, Zhang H, Richter FC, Meyer A, Lord J, Barnes E, Klenerman P, Green C, Simon AK. Autophagy in T cells from aged donors is maintained by spermidine and correlates with function and vaccine responses. Elife. 2020 Dec 15;9:e57950. doi: 10.7554/eLife.57950.

    PubMed 33317695

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ad6NSmut; AdCh3NSmut and AdCh3NSmut; 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?

To assess the safety of AdCh3NSmut and Ad6NSmut, when administered in a prime/boost regimen to healthy volunteers. The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. (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 NCT01070407, which also lists 1 linked publication.

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.

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