AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Children in a Malaria Endemic Area

Study Overview
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Brief Summary
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Infants in malaria-endemic regions of Africa are an important target for vaccination against malaria in view of the enormous disease burden of malaria in this population. 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 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. Administration of AdCh63 ME-TRAP and MVA ME-TRAP to infants in this study will occur at intervals of at least two weeks from the administration of routine infant immunisations, given according to the Gambian EPI.

Official Title
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Safety and Immunogenicity of Heterologous Prime-boost Vaccination With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Infants in a Malaria- Endemic Area

Conditions
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Malaria

Intervention / Treatment
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* Biological: AdCh63 ME-TRAP, MVA ME-TRAP
* Biological: AdCH63 ME-TRAP, MVA ME-TRAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infants aged 10 weeks and 5-12 months at the time of enrollment 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. 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 enrollment. 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 enrollment, the routine EPI vaccinations due according to the Gambian EPI schedule.

Ages Eligible for Study
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Minimum Age: 10 Weeks
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP | Biological: AdCh63 ME-TRAP, MVA ME-TRAP<br>* 1x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.<br>|
| Experimental: Group B<br>5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP | Biological: AdCH63 ME-TRAP, MVA ME-TRAP<br>* 5x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.<br>|
| No Intervention: Group C<br>5 to 12 months old infants; no vaccination | |
| Experimental: Group D<br>10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP | Biological: AdCh63 ME-TRAP, MVA ME-TRAP<br>* 1x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.<br>|
| Experimental: Group E<br>10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP | Biological: AdCH63 ME-TRAP, MVA ME-TRAP<br>* 5x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.<br>|
| No Intervention: Group F<br>10 week old babies; no vaccination | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP | 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 by recording local and systemic solicited and unsolicited adverse events | Participants will be followed for the duration of the study, an expected average of 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP | 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 by assessing induced antibody and T cell response to the vaccine insert | Participants will be followed for the duration of the study, an expected average of 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune response