Malaria Paediatrics
Conditions
Interventions
AdCh63 ME-TRAP followed by MVA ME-TRAP 8 weeks later
AdCh63 ME-TRAP followed by MVA ME-TRAP 8 weeks later
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For Stage 1: Healthy male and female infants aged 5-12 months at the time of enrolment with consenting parents. For Stage 2: Healthy male and female infants aged 10 weeks at the time of enrolment with consenting parents.
Exclusion criteria
Exclusion criteria: Any of the following constitutes an exclusion criterion: ¿Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness. ¿Severe malnutrition. ¿History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone. ¿History of splenectomy ¿Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator ¿Serum Creatinine concentration greater than 70 ¿mol/L, where judged to be clinically significant in the opinion of the investigator ¿Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator ¿Blood transfusion within one month of enrolment. ¿History of vaccination with previous experimental malaria vaccines. ¿Administration of any other vaccine or immunoglobulin less than two weeks before vaccination with the IMPs ¿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 ¿Maternal HIV infection ¿Positive malaria antigen test at screening ¿Failure to have received, prior to enrolment, the routine EPI vaccinations due according to the Gambian EPI schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the immunogenicity of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP | — |
Countries
Gambia
Contacts
Public ContactSanneh Mamkumba
Programme Manager
Outcome results
None listed