Malaria
Conditions
Keywords
Vaccine, Immune response
Brief summary
The purpose of this trial is to assess the safety and immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP candidate vaccines in healthy adult volunteers in a malaria endemic region. The regime proposed in this trial has protected non-immune volunteers against sporozoite challenge in clinical trials performed by Oxford, and so may be protective against naturally acquired infection in Kenya.The study population will comprise 30 healthy adult males aged 18-50. The investigators do not propose to include a placebo group. At this stage the investigators objective is to describe the safety profile in a small number of individuals, and the confidence intervals for the proportion of individuals with a particular event would be too wide for meaningful comparison with a placebo group. Immunogenicity will be judged by comparison with baseline.
Interventions
BIOLOGICALAdCh63 ME-TRAP followed by MVA ME-TRAP
AdCh63 ME-TRAP 1x10\^10 vp intramuscularly, MVA ME-TRAP 2x10\^8 pfu intramuscularly
Sponsors
Kenya Medical Research Institute
European and Developing Countries Clinical Trials Partnership (EDCTP)
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
* 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, see the investigators brochure for details, attached)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya. | Participants will be followed for the duration of the study, an expected average of 12 months | To assess safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya by recording local and systemic solicited and unsolicited adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of vaccines | Participants will be followed for the duration of the study, an expected average of 12 months | To evaluate the immunogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya by assessing induced antibody and T cell response to the vaccine insert. |
| Immunogenicity of Vaccines | Participants will be followed for the duration of the study, an expected average of 12 months | To compare the use of intra-muscular and intra-dermal MVA ME-TRAP |
Countries
Kenya
Outcome results
None listed