A Study to Assess the Safety of HIV and Hep C Vaccine Candidates When Given Separately or in Combination
A Phase I Study to Evaluate the Safety and Immunogenicity of Simultaneous Prime-Boost Immunisations With Candidate HCV and HIV-1 Vaccines, AdCh3NSmut1 / ChAdV63.HIVconsv and MVA-NSmut / MVA.HIVconsv, in Healthy Volunteers
1 other identifier
interventional
33
1 country
1
Brief Summary
This study is aimed at assessing the safety of candidate Hepatitis C vaccines AdCh3NSmut/MVA-NSmut and HIV vaccines ChAdV63.HIVconsv/MVA.HIVconsv when administered separately or in combination to healthy volunteers. The study also aims to assess the cellular immune response generated by these vaccines when 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 Oct 2014
Typical duration for phase_1
1 active site
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
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 6, 2014
CompletedFirst Posted
Study publicly available on registry
February 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedOctober 11, 2018
October 1, 2018
1.8 years
November 6, 2014
October 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Safety of administering simultaneous HCV/HIV-1 prime-boost vaccinations, as measured by the proportion of volunteers who develop a grade 3 or 4 local or systemic reaction
Proportion of volunteers who develop a grade 3 or 4 local reaction Proportion of volunteers who develop a grade 3 or 4 systemic reaction
Actively collected throughout the study until 6 months after the last vaccination
Secondary Outcomes (1)
Cellular immune response generated by simultaneous HCV/HIV-1 prime-boost vaccinations, as determined by analysing changes in the magnitude or quality of HCV and HIV-1-specific cellular immune responses.
Actively collected throughout the study until 6 months after the last vaccination
Study Arms (3)
Group 1
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\^8 pfu at week 8. Subjects: 8 healthy volunteers.
Group 2
EXPERIMENTALInterventions: ChAdV63.HIVconsv, MVA.HIVconsv. Administration schedule: 1 dose ChAdV63.HIVconsv 5 x 10\^10 vp at week 0 and 1 dose MVA.HIVconsv 2 x 10\^8 pfu at week 8. Subjects: 8 healthy volunteers.
Group 3
EXPERIMENTALInterventions: AdCh3NSmut1, MVA-NSmut, ChAdV63.HIVconsv, MVA.HIVconsv. Administration schedule: 1 dose AdCh3NSmut1 2.5 x 10\^10 vp and 1 dose ChAdV63.HIVconsv 5 x 10\^10 vp at week 0, and 1 dose MVA-NSmut 1 x 10\^8 pfu and 1 dose MVA.HIVconsv 1 x 10\^8 pfu at week 8. Subjects: 16 healthy volunteers.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy males or females, as assessed by medical history, physical examination and laboratory tests
- Aged at least 18 years on the day of screening and no greater than 50 years on the day of the first vaccination
- Resident in or easy access to the trial site for the duration of the study
- Available for follow-up for the planned duration of the study
- Able and willing (in the Chief 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, willingness to practice continuous effective contraception from screening until 4 months after the last immunisation.
- All female volunteers must be willing to undergo urine pregnancy tests at the time points specified in the Schedule of Procedures and must have a negative pregnancy test on the day(s) of vaccination
- For sexually active men, willingness to use an approved method of contraception until four months after the last vaccination
- Agreement to refrain from blood donation during the course of the study
- In the opinion of the Chief Investigator or designee, the volunteer has understood the information provided. Written informed consent must be given before any study-related procedures are performed
- Willing to undergo HCV/HIV-1 testing, counselling and receive test results
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 adenoviral vaccine
- Receipt of any investigational HIV-1 or HCV vaccine within the last 6 years
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Receipt of live attenuated vaccine within the previous 60 days or planned receipt within 60 days after vaccination with the IMP
- Receipt of other vaccine, including influenza vaccine, within the previous 14 days or planned receipt within 14 days after vaccination with the IMP
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressive 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
- History of clinically significant contact dermatitis
- Any history of anaphylaxis in reaction to vaccination
- Pregnancy, lactation or 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- ReiThera Srlcollaborator
- GlaxoSmithKlinecollaborator
Study Sites (1)
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Related Publications (1)
Hartnell F, Brown A, Capone S, Kopycinski J, Bliss C, Makvandi-Nejad S, Swadling L, Ghaffari E, Cicconi P, Del Sorbo M, Sbrocchi R, Esposito I, Vassilev V, Marriott P, Gardiner CM, Bannan C, Bergin C, Hoffmann M, Turner B, Nicosia A, Folgori A, Hanke T, Barnes E, Dorrell L. A Novel Vaccine Strategy Employing Serologically Different Chimpanzee Adenoviral Vectors for the Prevention of HIV-1 and HCV Coinfection. Front Immunol. 2019 Jan 18;9:3175. doi: 10.3389/fimmu.2018.03175. eCollection 2018.
PMID: 30713538DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lucy Dorrell, Prof.
University of Oxford
- PRINCIPAL INVESTIGATOR
Ellie Barnes, Prof.
University of Oxford
- PRINCIPAL INVESTIGATOR
Tomas Hanke, Prof.
University of Oxford
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2014
First Posted
February 12, 2015
Study Start
October 1, 2014
Primary Completion
August 1, 2016
Study Completion
October 31, 2017
Last Updated
October 11, 2018
Record last verified: 2018-10