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

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Immunogenicity of Heterologous Prime-boost With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Adults and Children 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
* Biological: AdCh63 ME-TRAP, MVA ME-TRAP
* Biological: AdCh63 ME-TRAP, MVA ME-TRAP
* Biological: HDCRV
* Biological: AdCh63 ME-TRAP, MVA ME-TRAP
* Biological: AdCh63 ME-TRAP, MVA ME-TRAP
* Biological: HDCRV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

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 1A<br>Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP | Biological: AdCh63 ME-TRAP, MVA ME-TRAP<br>* AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later<br>|
| Experimental: Group 1B<br>Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME TRAP | Biological: AdCh63 ME-TRAP, MVA ME-TRAP<br>* AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later<br>|
| Experimental: Group 2A<br>Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP | Biological: AdCh63 ME-TRAP, MVA ME-TRAP<br>* AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later<br>|
| Experimental: Group 2B<br>Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP | Biological: AdCh63 ME-TRAP, MVA ME-TRAP<br>* AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later<br>|
| Active Comparator: Group 2C<br>Children (2-6 years old) vaccinated with human diploid cell rabies vaccine | Biological: HDCRV<br>* HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later<br>|
| Experimental: Group 3A<br>Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP | Biological: AdCh63 ME-TRAP, MVA ME-TRAP<br>* AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later<br>|
| Experimental: Group 3B<br>Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP | Biological: AdCh63 ME-TRAP, MVA ME-TRAP<br>* AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later<br>|
| Active Comparator: Group 3C<br>Children (2-6 years old) vaccinated with human diploid cell rabies vaccine | Biological: HDCRV<br>* HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP | 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 | Participants will be followed for the duration of the study, an expected average of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP | 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. | Participants will be followed for the duration of the study, an expected average of 12 months | 

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