Efficacy Study of ChAd63-MVA ME-TRAP prime-boost Vaccination against Plasmodium
- Conditions
- Malaria
- Registration Number
- PACTR201303000499409
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 160
Consenting adult males aged 18-50 yrs in good health.
Will remain resident in the study area for the study duration.
Able and willing (in the investigators opinion) to comply with all study requirements
Informed consent.
1. Any significant medical disease, disorder, finidng which may significantly increase the risk of the volunteer because of participantion in the sutdy, affect the ability of the volunteer to participate in the study or impair tinterpretation of the study data.
2. Hypersensitivity to HDCRV, the tiral vaccine or the antimalarial use.
3. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, eg egg products, kathon, neomycin
4. Haemoglobin <10 g/dl
5.Clinically significant abnormalities of laboratory screening tests (full blood count, ALT, creatinine levels)
6. Blood transfusion within month of enrollemnt
7.History of vaccination with previous experimental malaria vaccines or other vaccines likely to impact on findins of study(eg. other MVA or adenovirus vectoredvaccines)
8.Administration of any other vaccine or immunoglobulin with 2 wks before vaccination
9. HIV or Hep B surface antigen seropositivity
10. Current participation in another clin trial of recent participatnin within 12 wks of study
11. Any other finding which in opinion of investigators would increase tisk of adverse outcome from participation in trial
12. Likihood of travel away from study area
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint - Vaccine efficacy
- Secondary Outcome Measures
Name Time Method Measures of immunogenicity will include;