Malaria Paediatrics
Conditions
Interventions
Group2 Day 0 High dose AdCh63 ME-TRAP followed by day 63 MVA ME-TRAP
Group1 Day 0 low dose AdCh63 ME-TRAP followed by day 63 MVA ME-TRAP
Sponsors
University of Oxford
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: ·Consenting adult males aged 18-50 years in good health. ·Will remain resident in the study area for the study duration
Exclusion criteria
Exclusion criteria: ·Clinically significant history of the following conditions; skin disorder (eczema, etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness. ·History of splenectomy ·Haemoglobin less than 9.0 g/dl ·Clinically significant abnormalities of laboratory screening tests (full blood count, ALT, creatinine levels, urine dipstick examination for blood and protein). ·Blood transfusion within one month of the beginning of the study · History of vaccination with previous experimental malaria vaccines ·Administration of any other vaccine or immunoglobulin within two weeks before vaccination. ·Current participation in another clinical trial, or within 12 weeks of this study ·Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial. ·Likelihood of travel away from the study area ·HIV positive. ·History of contact dermatitis (due to the use of a potentially irritant disinfectant that may be present in trace amounts in the AdCh63 ME-TRAP vaccine)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and biological safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Reactogenicity of the vaccines;Immunogenicity | — |
Countries
Kenya
Contacts
Public ContactPeninah Menza
Study Coordinator
Outcome results
None listed