A Study of a New Candidate Vaccine Against Hepatitis C Virus (HCV)
NCT ID: NCT01070407
Last Updated: 2015-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2007-07-31
2011-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm A, group 1
4 volunteers
Ad6NSmut; 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.
Arm A, group 2
4 volunteers
Ad6NSmut; 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.
Arm A, group 3
5 volunteers
Ad6NSmut; 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.
Arm B, group 5
4 volunteers
AdCh3NSmut; 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.
Arm B, group 6
4 volunteers
AdCh3NSmut; 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.
Arm B, group 7
5 volunteers
AdCh3NSmut; 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.
Arm C, group 9
5 volunteers
Ad6NSmut; AdCh3NSmut
1 dose Ad6NSmut 2.5 x 10\^10vp at week 0 and 1 dose AdCh3NSmut 2.5 x 10\^10vp at week 8.
Arm C, group 10
5 volunteers
AdCh3NSmut; Ad6NSmut
1 dose AdCh3NSmut 2.5 x 10\^10vp at week 0 and 1 dose Ad6NSmut 2.5 x 10\^10vp at week 8.
Arm C, group 11
4 volunteers
AdCh3NSmut; Ad6NSmut
1 dose AdCh3NSmut 7.5 x 10\^10vp at week 0 and 1 dose Ad6NSmut 7.5 x 10\^10vp at week 8.
Interventions
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Ad6NSmut; 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.
Ad6NSmut; 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.
Ad6NSmut; 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.
AdCh3NSmut; 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.
AdCh3NSmut; 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.
AdCh3NSmut; 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.
Ad6NSmut; AdCh3NSmut
1 dose Ad6NSmut 2.5 x 10\^10vp at week 0 and 1 dose AdCh3NSmut 2.5 x 10\^10vp at week 8.
AdCh3NSmut; Ad6NSmut
1 dose AdCh3NSmut 2.5 x 10\^10vp at week 0 and 1 dose Ad6NSmut 2.5 x 10\^10vp at week 8.
AdCh3NSmut; Ad6NSmut
1 dose AdCh3NSmut 7.5 x 10\^10vp at week 0 and 1 dose Ad6NSmut 7.5 x 10\^10vp at week 8.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
50 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
ReiThera Srl
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Klenerman, Professor
Role: STUDY_CHAIR
University of Oxford, UK
David Adams, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Birmingham
Locations
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Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, United Kingdom
Wellcome Clinical Research Facility, Queen Elizabeth's Hospital, University Hospital Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Countries
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References
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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.
Related Links
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HCV001 Study sponsor web site
Other Identifiers
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2007-004259-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GTAC144
Identifier Type: OTHER
Identifier Source: secondary_id
HCV001
Identifier Type: -
Identifier Source: org_study_id
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