A Study of a New Candidate Vaccine Against Hepatitis C Virus (HCV)
A Phase I Study to Assess the Safety and Immunogenicity of New Hepatitis C Virus Vaccine Candidates AdCh3NSmut and Ad6NSmut
3 other identifiers
interventional
41
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2007
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 16, 2010
CompletedFirst Posted
Study publicly available on registry
February 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedApril 23, 2015
April 1, 2015
3.1 years
February 16, 2010
April 22, 2015
Conditions
Keywords
Outcome Measures
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.
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.
Different time points depending on the study groups with a 6-months follow-up after last vaccination for all groups
Study Arms (9)
Arm A, group 1
EXPERIMENTAL4 volunteers
Arm A, group 2
EXPERIMENTAL4 volunteers
Arm A, group 3
EXPERIMENTAL5 volunteers
Arm B, group 5
EXPERIMENTAL4 volunteers
Arm B, group 6
EXPERIMENTAL4 volunteers
Arm B, group 7
EXPERIMENTAL5 volunteers
Arm C, group 9
EXPERIMENTAL5 volunteers
Arm C, group 10
EXPERIMENTAL5 volunteers
Arm C, group 11
EXPERIMENTAL4 volunteers
Interventions
2 doses Ad6NSmut 5 x 10\^8vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10\^10vp at week 24.
2 doses AdCh3NSmut 5 x 10\^8vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10\^10vp at week 24.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ReiThera Srllead
- University of Oxfordcollaborator
Study Sites (2)
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
Related Publications (1)
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.
PMID: 33317695DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul Klenerman, Professor
University of Oxford, UK
- PRINCIPAL INVESTIGATOR
David Adams, Professor
University of Birmingham
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2010
First Posted
February 18, 2010
Study Start
July 1, 2007
Primary Completion
August 1, 2010
Study Completion
February 1, 2011
Last Updated
April 23, 2015
Record last verified: 2015-04