Malaria
Conditions
Keywords
Vaccine, Immune response
Brief summary
The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children and adult volunteers in a malaria endemic region. The regimen proposed here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be protective against naturally acquired infection in The Gambia.
Interventions
BIOLOGICALAdCh63 ME-TRAP, MVA ME-TRAP
AdCh63 ME-TRAP 1 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later
BIOLOGICALHDCRV
HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later
Sponsors
European and Developing Countries Clinical Trials Partnership (EDCTP)
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
2 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Consenting adult males aged 18-50 years in good health and healthy children aged 2-6 years.with consenting parents.
Exclusion criteria
* 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. * Hypersensitivity to HDCRV. * 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 9.0 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 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. * Positive malaria antigen test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP | Participants will be followed for the duration of the study, an expected average of 12 months | To assess the safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults and children in The Gambia by recording local and systemic solicited and unsolicited adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP | Participants will be followed for the duration of the study, an expected average of 12 months | To assess the immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults and children in The Gambia by assessing induced antibody and T cell response to the vaccine insert. |
Countries
The Gambia
Outcome results
None listed