A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of New Plasmodium Falciparum Malaria Vaccine Candidates ChAd63 RH5 Alone and With MVA RH5
NCT ID: NCT02181088
Last Updated: 2015-12-03
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
26 participants
INTERVENTIONAL
2014-08-31
2015-10-31
Brief Summary
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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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Group 1 (ChAd63 RH5 low dose)
1 dose of ChAd63 RH5 5 x 10\^9 vp intramuscularly
ChAd63 RH5 low dose
ChAd63 RH5 at 5 x 10\^9 vp
Group 2A (ChAd63 RH5 full dose)
1 dose of ChAd63 RH5 at 5 x 10\^10 vp intramuscularly
ChAd63 RH5 full dose
ChAd63 RH5 at 5 x 10\^10 vp
Group 2B (ChAd63 RH5 full dose and MVA RH5 low dose)
1 dose of ChAd63 RH5 at 5 x 10\^10 vp intramuscularly and 1 dose MVA RH5 at 1 x 10\^8 pfu 8 weeks later intramuscularly
ChAd63 RH5 full dose
ChAd63 RH5 at 5 x 10\^10 vp
MVA RH5 low dose
MVA RH5 at 1 x 10\^8 pfu
Group 2C (ChAd63 RH5 full dose and MVA RH5 full dose)
1 dose of ChAd63 RH5 at 5 x 10\^10 vp intramuscularly and 1 dose MVA RH5 at 2 x 10\^8 pfu 8 weeks later intramuscularly
ChAd63 RH5 full dose
ChAd63 RH5 at 5 x 10\^10 vp
MVA RH5 full dose
MVA RH5 at 2 x 10\^8 pfu
Interventions
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ChAd63 RH5 low dose
ChAd63 RH5 at 5 x 10\^9 vp
ChAd63 RH5 full dose
ChAd63 RH5 at 5 x 10\^10 vp
MVA RH5 low dose
MVA RH5 at 1 x 10\^8 pfu
MVA RH5 full dose
MVA RH5 at 2 x 10\^8 pfu
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
Exclusion Criteria
* Prior receipt of an investigational malaria vaccine or any other 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 human immunodeficiency virus (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. egg products.
* 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 in the 5 years preceding enrolment
* Seropositive for hepatitis B surface antigen (HBsAg)
* Seropositive for hepatitis C virus (antibodies to HCV)
* History of clinical malaria (any species)
* Travel to a malaria endemic region during the study period or within the previous six months
* Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
* Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
* Inability of the study team to contact the volunteer's general practitioner (GP) to confirm medical history and safety to participate
18 Years
50 Years
ALL
Yes
Sponsors
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European Commission
OTHER
University of Oxford
OTHER
Responsible Party
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Locations
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Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, , United Kingdom
Wellcome Trust CRF, Southampton General Hospital, University of Southampton
Southampton, , United Kingdom
Countries
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Other Identifiers
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2013-005458-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VAC057
Identifier Type: -
Identifier Source: org_study_id