Safety and Immunogenicity of New Malaria Vaccine Candidate ChAd63 CS Administered Alone and With MVA CS
NCT ID: NCT01450280
Last Updated: 2012-11-29
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
24 participants
INTERVENTIONAL
2011-12-31
2012-10-31
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 1A
AdCh63 CS 5x10\^9 vp
ChAd63 CS
ChAd63 CS 5x10\^9 vp intra-muscularly Day 0
Group 1B
ChAd63 CS 5x10\^9 vp Day 0; MVA CS 2x10\^8 pfu Day 56
ChAd63 CS, MVA CS
ChAd63 CS 5x10\^9 vp intra-muscularly Day 0; MVA CS 2x10\^8 pfu intra-muscularly Day 56
Group 2A
AdCh63 CS 5 x 10\^10 vp
ChAd63 CS
ChAd63 CS 5x10\^10 vp intra-muscularly Day 0
Group 2B
ChAd63 CS 5x10\^10 vp Day 0; MVA CS 2x10\^8 pfu Day 56
ChAd63, MVA CS
ChAd63 CS 5x10\^10 vp intra-muscularly Day 0; MVA CS 2x10\^8 pfu intra-muscularly Day 56
Interventions
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ChAd63 CS
ChAd63 CS 5x10\^9 vp intra-muscularly Day 0
ChAd63 CS, MVA CS
ChAd63 CS 5x10\^9 vp intra-muscularly Day 0; MVA CS 2x10\^8 pfu intra-muscularly Day 56
ChAd63 CS
ChAd63 CS 5x10\^10 vp intra-muscularly Day 0
ChAd63, MVA CS
ChAd63 CS 5x10\^10 vp intra-muscularly Day 0; MVA CS 2x10\^8 pfu intra-muscularly Day 56
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
* Women only: Must practice continuous effective contraception for the duration of the study
* Agreement to refrain from blood donation during the course of the study and for 6 months after the end of their involvement in the study.
* Written informed consent
Exclusion Criteria
* Travel to a malaria endemic region during the study period or within the preceding six months with a significant risk of malaria exposure.
* 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 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 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)
* Pregnancy, breast feeding or intention to become pregnant during the study
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine e.g. egg products, Kathon.
* History of clinically significant contact dermatitis.
* Any history of anaphylaxis post vaccination.
* History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
* History of serious psychiatric condition that may affect participation in the study.
* 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).
* Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination.
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Sam McConkey
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Centre Royal College of Surgeons in Ireland (RCSI)
Locations
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Clinical Research Centre Royal College of Surgeons in Ireland (RCSI), Beaumont Hospital
Dublin, , Ireland
Countries
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References
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de Barra E, Hodgson SH, Ewer KJ, Bliss CM, Hennigan K, Collins A, Berrie E, Lawrie AM, Gilbert SC, Nicosia A, McConkey SJ, Hill AV. A phase Ia study to assess the safety and immunogenicity of new malaria vaccine candidates ChAd63 CS administered alone and with MVA CS. PLoS One. 2014 Dec 18;9(12):e115161. doi: 10.1371/journal.pone.0115161. eCollection 2014.
Other Identifiers
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VAC038
Identifier Type: -
Identifier Source: org_study_id