EUCTR2009-012591-27-GB
Active, Not Recruiting
N/A
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
ConditionsPlasmodium Falciparum Malaria
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Plasmodium Falciparum Malaria
- Sponsor
- niversity of Oxford
- Enrollment
- 16
- Status
- Active, Not Recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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