A phase I/IIa study to assess the safety and immunogenicity of new malaria vaccine candidates AdCh63 MSP1 alone and with MVA MSP1 - A study of the safety and effectiveness of two new malaria vaccines
- Conditions
- Plasmodium Falciparum Malaria
- Registration Number
- EUCTR2009-012591-27-GB
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16
•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 during the study and a negative pregnancy test on the day(s) of vaccination and / or challenge
•For males only, to use barrier contraception until three months after the last vaccination
•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
•Significant concern raised by GP in relation to participation
• 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 adenoviral and/or MVA vectored vaccine.
•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, e.g. egg products, Kathon.
•History of clinically significant contact dermatitis
•Contraindication to both anti-malarial drugs (Riamet® and chloroquine)
oconcomitant use with other drugs known to cause QT-interval prolongation, (e.g. macrolides, quinolones, amiodarone etc)
•A predicted ten year risk of fatal cardiovascular disease of =5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system
•History of arrhythmia or congenital QT interval prolongation
•Family history of sudden cardiac death
•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
•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.
•Any history of malaria or
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method