A Study to Assess the Safety and Immunogenicity of a Candidate Malaria Vaccine Using Novel Routes of Administration
A Phase I Study to Assess the Safety and Immunogenicity of Novel Routes of Administration of Plasmodium Falciparum Malaria Vaccine Candidates ChAd63 and MVA Encoding ME-TRAP.
1 other identifier
interventional
26
1 country
1
Brief Summary
The purpose of this study is to assess the safety and immunogenicity of novel routes of administration of the candidate malaria vaccines ChAd63 encoding ME-TRAP and MVA encoding ME-TRAP. 30-33 Healthy adult volunteers will be recruited in Oxford. All vaccinations will be administered intravenously or subcutaneously. Each volunteer will receive a single vaccination of ChAd63 ME-TRAP or MVA ME-TRAP at different doses depending on the group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2017
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
First Submitted
Initial submission to the registry
March 3, 2017
CompletedFirst Posted
Study publicly available on registry
March 20, 2017
CompletedStudy Start
First participant enrolled
March 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2020
CompletedOctober 9, 2020
August 1, 2020
3.3 years
March 3, 2017
October 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of occurrence of emergent adverse events related to subcutaneous and intravenous administration of ChAd63 ME-TRAP and MVA ME-TRAP in healthy malaria-naïve volunteers
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events (including solicited local or systemic reactogenicity signs and symptoms for 7 days following the vaccination; occurrence of unsolicited adverse events for 28 days following vaccination, and the occurrence of serious adverse events throughout the 3 month study duration).
3 months
Secondary Outcomes (2)
Identify potential biomarkers of vaccine deposition in the liver (biomolecules measured will include: liver enzymes and plasma cytokine levels).
3 months
Assess changes in immune response before and after vaccination using exploratory immunological assays.
3 months
Study Arms (8)
Group 1
EXPERIMENTALGroup 1 will receive ChAd63-METRAP at the dose of 5x10\^8 vp i.v.
Group 2
EXPERIMENTALGroup 2 will receive ChAd63-METRAP at the dose of 5x10\^9 vp i.v.
Group 3
EXPERIMENTALGroup 3 will receive ChAd63-METRAP at the dose of 5x10\^10 vp i.v.
Group 4
EXPERIMENTALGroup 4 will receive ChAd63-METRAP at the dose of 5x10\^10 vp s.c.
Group 5
EXPERIMENTALGroup 5 will receive ChAd63-METRAP at the dose of 2x10\^11 vp s.c.
Group 6
EXPERIMENTALGroup 6 will receive MVA METRAP at the dose of 2 x 10\^6 pfu i.v.
Group 7
EXPERIMENTALGroup 7 will receive MVA METRAP at the dose of 2 x 10\^7 pfu i.v.
Group 8
EXPERIMENTALGroup 8 will receive MVA METRAP at the dose of 2 x 10\^8 pfu i.v.
Interventions
The candidate vaccine applicable to the clinical trial is the Chimpanzee adenovirus 63 expressing Multiple epitopes and thrombospondin related adhesion protein.
The candidate vaccine applicable to the clinical trial is the Modified Vaccinia virus Ankara expressing Multiple epitopes and thrombospondin related adhesion protein.
Eligibility Criteria
You may qualify if:
- Healthy adults aged 18 to 50 years
- 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 contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
- Agreement to refrain from blood donation during the course of the study
- Provide written informed consent
You may not qualify if:
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data.
- 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
- Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
- Any history of anaphylaxis in relation 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 likely to affect participation in the study
- Bleeding disorder (e.g. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
- 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 in the 5 years preceding enrolment
- Seropositive for hepatitis B surface antigen (HBsAg)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, OX3 7LE, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian V Hill, DPhill FRCP
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom
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
March 3, 2017
First Posted
March 20, 2017
Study Start
March 28, 2017
Primary Completion
July 6, 2020
Study Completion
July 6, 2020
Last Updated
October 9, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share