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CompletedNCT01070407Updated Apr 23, 2015

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

A Phase 1 interventional study of Ad6NSmut; AdCh3NSmut and Ad6NSmut; AdCh3NSmut in Hepatitis C, sponsored by ReiThera Srl. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-23.

Sponsored by ReiThera Srl · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
41
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hepatitis C

Keywords

  • Hepatitis C virus
  • HCV
  • Adenovirus
  • Vaccine
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 41 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

ReiThera Srl is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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
  • 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

Exclusion criteria

Exclusion Criteria:

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
  • 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)
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Arm A, group 1

    4 volunteers

    Biological: Ad6NSmut; AdCh3NSmut

  • Experimental
    Arm A, group 2

    4 volunteers

    Biological: Ad6NSmut; AdCh3NSmut

  • Experimental
    Arm A, group 3

    5 volunteers

    Biological: Ad6NSmut; AdCh3NSmut

  • Experimental
    Arm B, group 5

    4 volunteers

    Biological: AdCh3NSmut; Ad6NSmut

  • Experimental
    Arm B, group 6

    4 volunteers

    Biological: AdCh3NSmut; Ad6NSmut

  • Experimental
    Arm B, group 7

    5 volunteers

    Biological: AdCh3NSmut; Ad6NSmut

  • Experimental
    Arm C, group 9

    5 volunteers

    Biological: Ad6NSmut; AdCh3NSmut

  • Experimental
    Arm C, group 10

    5 volunteers

    Biological: AdCh3NSmut; Ad6NSmut

  • Experimental
    Arm C, group 11

    4 volunteers

    Biological: AdCh3NSmut; Ad6NSmut

Interventions

  • BiologicalAd6NSmut; AdCh3NSmut

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

  • BiologicalAd6NSmut; AdCh3NSmut

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

  • BiologicalAd6NSmut; AdCh3NSmut

    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.

  • BiologicalAdCh3NSmut; Ad6NSmut

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

  • BiologicalAdCh3NSmut; Ad6NSmut

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

  • BiologicalAdCh3NSmut; Ad6NSmut

    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.

  • BiologicalAd6NSmut; AdCh3NSmut

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

  • BiologicalAdCh3NSmut; Ad6NSmut

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

  • BiologicalAdCh3NSmut; Ad6NSmut

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

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

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

07

Study locations

2 sites
  • Centre for Clinical Vaccinology and Tropical Medicine
    Oxford, Oxfordshire OX3 7LJ, United Kingdom
  • Wellcome Clinical Research Facility, Queen Elizabeth's Hospital, University Hospital Birmingham NHS Foundation Trust
    Birmingham, West Midlands B15 2TH, United Kingdom
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01070407
Lead sponsor
ReiThera Srl
Collaborators
University of Oxford
Responsible party
Sponsor
First posted
Feb 18, 2010
Start date
Jul 2007
Primary completion
Aug 2010
Completion
Feb 2011
Last update
Apr 23, 2015

Study contacts

Paul Klenerman, Professor
study chair · University of Oxford, UK
David Adams, Professor
principal investigator · University of Birmingham

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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