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| Name | Class |
|---|---|
| European and Developing Countries Clinical Trials Partnership (EDCTP) | OTHER_GOV |
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Prime boost vaccination with ChAd63 ME-TRAP followed eight weeks later with MVA ME-TRAP shows efficacy against malaria infection when tested in UK volunteers using sporozoite challenge experiments. It is a leading candidate vaccination strategy against malaria. In the field, Phase I studies have been conducted in adults in Kenya and The Gambia and children and infants in The Gambia. The vaccination strategy appears safe and well tolerated in these populations, and also shows impressive immunogenicity, not significantly different to that seen in the UK trials where efficacy was shown. In particular, recent data from The Gambia shows excellent safety and immunogenicity in infants in malaria endemic areas, who would be the ones to benefit most from such a vaccine against malaria. With this clinical development as background, the investigators now propose to evaluate efficacy against natural malaria infection in this important target group for an effective malaria vaccine, that is, 5-17 month infants and children living in malaria endemic areas. The proposed study area, Banfora, Burkina Faso, is highly endemic for Plasmodium falciparum malaria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ChAd63 ME-TRAP and MVA ME-TRAP | Active Comparator | ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime-boost immunisation |
|
| Rabies vaccine | Placebo Comparator | 2 x 2.5IU Verorab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChAd63 ME-TRAP and MVA ME-TRAP | Biological | ChAd63 ME-TRAP: 5 x 10^10vp MVA ME-TRAP: 1 x 10^8 pfu heterologous prime-boost immunisation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first episode of malaria meeting the primary case definition of clinical malaria episode | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Protective efficacy against clinical malaria | To assess the protective efficacy against clinical malaria of ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, for 12 and 24* months after the last vaccination. | 12 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Vaccinology and 1. Centre National de Recherche et de Formation sur le Paludisme (CNRFP)/ Unité de Recherche Clinique de Banfora (URC-B) | Ouagadougou | BP 2208 | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36532031 | Derived | Morter R, Tiono AB, Nebie I, Hague O, Ouedraogo A, Diarra A, Viebig NK, Hill AVS, Ewer KJ, Sirima SB. Impact of exposure to malaria and nutritional status on responses to the experimental malaria vaccine ChAd63 MVA ME-TRAP in 5-17 month-old children in Burkina Faso. Front Immunol. 2022 Dec 2;13:1058227. doi: 10.3389/fimmu.2022.1058227. eCollection 2022. | |
| 30540808 |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| D011819 | Rabies Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Rabies vaccine | Biological | Two doses eight weeks apart into anterolateral thigh. 2 x 2.5IU Verorab |
|
| Efficacy against asymptomatic P. falciparum infection |
To assess the protective efficacy against asymptomatic P. falciparum infection of ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, 6, 12 and 24* months after the last vaccination |
| 6, 12 and 24 months |
| Efficacy against secondary case definitions of clinical malaria | To assess the protective efficacy against secondary case definitions of clinical malaria of ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, for 6, 12 and 24 months after the last vaccination | 6, 12 and 24 months |
| Safety Objective | To assess the safety and reactogenicity of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, for 6, 12 and 24 months after the last vaccination. | 6, 12 and 24 months |
| Immunogenicity Objectives |
| 24 months |
| Tiono AB, Nebie I, Anagnostou N, Coulibaly AS, Bowyer G, Lam E, Bougouma EC, Ouedraogo A, Yaro JBB, Barry A, Roberts R, Rampling T, Bliss C, Hodgson S, Lawrie A, Ouedraogo A, Imoukhuede EB, Ewer KJ, Viebig NK, Diarra A, Leroy O, Bejon P, Hill AVS, Sirima SB. First field efficacy trial of the ChAd63 MVA ME-TRAP vectored malaria vaccine candidate in 5-17 months old infants and children. PLoS One. 2018 Dec 12;13(12):e0208328. doi: 10.1371/journal.pone.0208328. eCollection 2018. |
| D000079426 |
| Vector Borne Diseases |