Assessment of protection against malaria by sporozoite challenge of healthy adults vaccinated with AdCh63 ME-TRAP and MVA ME-TRAP

• Conditions: Malaria

• Registration Number: EUCTR2008-006804-46-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

The volunteer must satisfy all the following criteria to be eligible for the study:
•Healthy adult 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 practise effective contraception throughout the study
•Agreement to refrain from blood donation during the course of the study
•Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The volunteer may not enter the study if any of the following apply:
•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 encoding ME-TRAP 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, lactation or intention to become pregnant during the study
•Contraindication to both anti-malarial drugs (chloroquine)
oconcomitant use with other drugs known to cause QT-interval prolongation, ( e.g. macrolides, quinolones, amiodarone etc)
ohistory of epilepsy
•An estimated, ten year risk of fatal cardiovascular disease of =5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system [58]
•History of arrhythmia or prolonged QT interval;
•positive family history for sudden death
•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 in reaction to vaccination
•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
•Seropositive for hepatitis B surface antigen (HBsAg)
•Seropositive for hepatitis C virus (antibodies to HCV)
•Any other significant disease, disorder or finding, which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer’s ability to participate in the study.
•History of clinical P. falciparum malaria
•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 finding which in the opinion of the investigators would significantly increase the risk of having an adverse outcome from participating in the protocol or impair interpretation of the study data.
Re-vaccination exclusion criteria
The following adverse events associated with vaccine immunisation constitute absolute contraindications to further administration of vaccine. If any of these events occur during the study, the subject must be withdrawn and followed until resolution of the event, as with any adverse event.
Anaphylactic reaction following administration of vaccine
Pregnancy

The following adverse events constitute contraindications to administration of vaccine at that point in time; if any one of these adverse events occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, or withdrawn at the discretion of the investigator. The subject must be followed until resolution o

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified