Study of a New MVA Vaccine for Hepatitis C Virus
A Phase I Study to Assess the Safety and Immunogenicity of AdCh3NSmut and MVA-NSmut in Healthy Volunteers and Patients With Hepatitis C Virus Infection
2 other identifiers
interventional
55
1 country
3
Brief Summary
The study is aimed at assessing the safety of AdCh3NSmut and the new candidate vaccine MVA-NSmut when administered sequentially, or alone, to healthy volunteers and patients with hepatitis C virus infection The study also aims at assessing the cellular immune response generated by AdCh3NSmut and MVA-NSmut administered as mentioned above.
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 Dec 2010
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 9, 2011
CompletedFirst Posted
Study publicly available on registry
February 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedApril 26, 2016
April 1, 2016
5.1 years
February 9, 2011
April 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participant with adverse events, type and severity of adverse events
To assess the safety of new hepatitis C vaccine candidates, AdCh3NSmut (and the improved version AdCh3NSmut1) and MVA-NSmut when administered to healthy volunteers and to HCV infected patients. The specific endpoints for safety will be actively collected data on adverse events.
Different time frames depending on study groups
Secondary Outcomes (1)
Immunogenicity
Different time frames depending on the study groups
Study Arms (10)
Arm A, group1
EXPERIMENTALIntervention: MVA-NSmut. Administration schedule: 1 dose MVA-NSmut 2 x 10\^8 pfu. Subjects: 4 healthy volunteers
Arm A, group 2
EXPERIMENTALInterventions: AdCh3NSmut; MVA-NSmut. Administration schedule: 1 dose AdCh3NSmut 2.5 x 10\^10vp at week 0 and 1 dose MVA-NSmut 2 x 10\^8 pfu at week 8. Subjects: 10 healthy volunteers
Arm B, group 1
EXPERIMENTALInterventions: AdCh3NSmut; MVA-NSmut. Administration schedule: 1 dose AdCh3NSmut 2.5 x 10\^10vp at week 14 and 1 dose MVA-NSmut 2 x 10\^8pfu at week 22, after starting PEG-IFN and ribavirin therapy. Subjects: 5 patients
Arm B, group 2
EXPERIMENTALInterventions: AdCh3NSmut; MVA-NSmut.. Administration schedule: 1 dose AdCh3NSmut 2.5 x 1010vp at week 2 and 1 dose MVA-NSmut 2 x 108pfu at week 10, after starting PEG-IFN and ribavirin therapy. Subjects: 5 patients
Arm C, group 1
EXPERIMENTALInterventions: AdCh3NSmut; MVA-NSmut Administration schedule: 1 dose AdCh3NSmut 2.5 x 10\^10vp at week 0 and 1 dose MVA-NSmut 2 x 10\^8pfu at week 8. Subjects: 4 patients
Arm A, group 3
EXPERIMENTALInterventions: AdCh3NSmut; MVA-NSmut Administration schedule: 1 dose AdCh3NSmut 2.5 x 10\^10vp at week 0, 1 dose MVA-NSmut 2 x 10\^8pfu at week 8, 1 dose AdCh3NSmut 2.5 x 10\^10vp at week 16 and 1 dose MVA-NSmut 2 x 10\^8 pfu at week 24. Subjects: 5 healthy volunteers
Arm A, group 4
EXPERIMENTALIntervention: AdCh3NSmut; MVA-NSmut. Administration schedule: 1 dose AdCh3NSmut 2.5 x 10\^10vp (at least 6 months after they were initially enrolled) and 1 dose MVA-NSmut 2 x 10\^8 pfu 8 weeks later. Subjects: up to 5 healthy volunteers who were previously in group A2
Experimental: Arm A, group5
EXPERIMENTALIntervention: AdCh3NSmut1. MVA-NSmut. Administration schedule:1 dose AdCh3NSmut1 2.5 x 10\^10vp at week 0, 1 dose MVA-NSmut 2 x 10\^8 pfu at week 8 and 1 dose MVA-NSmut 2 x 10\^8 pfu at week 40. Subjects: 5 healthy volunteers
Arm A, group 6
EXPERIMENTALInterventions: AdCh3NSmut1. Administration schedule: 1 dose AdCh3NSmut1 2.5 x 10\^10 vp at week 0 and 1 dose MVA-NSmut 2 x 10\^7 pfu at week 8. Subjects: 5 healthy volunteers
Arm A, group 7
EXPERIMENTALInterventions: AdCh3NSmut1; MVA-NSmut. Administration schedule: 1 dose AdCh3NSmut1 2.5 x 10\^10 vp at week 0 and 1 dose MVA-NSmut 2 x 10\^6 pfu at week 8. Subjects: 5 healthy volunteers
Interventions
Genetic vaccine against Hepatitis C virus infection
genetic vaccine against Hepatitis virus infection
genetic vaccine against Hepatitis virus infection
Eligibility Criteria
You may qualify if:
- Healthy adults aged 18 to 55 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
- 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
- Men, including those with pregnant partners, should use barrier contraception until 3 months after the last vaccination
- Written informed consent
- HCV infected with genotype-1 infection (any viral load)
- Patients must not be currently receiving any treatment for HCV infection.
- Adults aged 18 to 64 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
- Liver transaminases may be within normal limits or elevated.
- For men in Arm B, including those with pregnant partners, a willingness to use barrier contraception until six months after completing treatment with IFN/ribavirin
- For women in Arm B, of child bearing potential, a willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of vaccination.
- For men in arm C, including those with pregnant partners, a willingness to use barrier contraception until three months after the last vaccination
- +3 more criteria
You may not qualify if:
- 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 (abnormal liver synthetic dysfunction defined by an elevated blood prothrombin time or a low blood albumin level), 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)
- 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)
- 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
- 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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ReiThera Srllead
- University of Oxfordcollaborator
- Oxford University Hospitals NHS Trustcollaborator
- University Hospital Birminghamcollaborator
Study Sites (3)
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, OX3 7LJ, United Kingdom
John Radcliffe Hospital, Headley Way
Headington, Oxford, OX3 9DU, United Kingdom
Wycombe Hospital, High Wycombe, Buckinghamshire
High Wycombe, United Kingdom
Related Publications (2)
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: 33317695DERIVEDSwadling L, Capone S, Antrobus RD, Brown A, Richardson R, Newell EW, Halliday J, Kelly C, Bowen D, Fergusson J, Kurioka A, Ammendola V, Del Sorbo M, Grazioli F, Esposito ML, Siani L, Traboni C, Hill A, Colloca S, Davis M, Nicosia A, Cortese R, Folgori A, Klenerman P, Barnes E. A human vaccine strategy based on chimpanzee adenoviral and MVA vectors that primes, boosts, and sustains functional HCV-specific T cell memory. Sci Transl Med. 2014 Nov 5;6(261):261ra153. doi: 10.1126/scitranslmed.3009185.
PMID: 25378645DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eleanor Barnes, Dr.
University of Oxford, UK
- PRINCIPAL INVESTIGATOR
Paul Klenerman, Prof.
University of Oxford, UK
- PRINCIPAL INVESTIGATOR
David Gorard, Dr
Wycombe Hospital, High Wycombe, Buckinghamshire
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2011
First Posted
February 15, 2011
Study Start
December 1, 2010
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
April 26, 2016
Record last verified: 2016-04