A Phase 1 interventional study of AdCh63 AMA1 and AdCh63 AMa1 and MVA AMA1 in Malaria, sponsored by University of Oxford. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-03-28.
Sponsored by University of Oxford · Phase 1, Interventional, and Prevention
This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63 AMA1, simian adenovirus encoding Plasmodium falciparum blood stage antigen, Apical Membrane Antigen -1. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 AMA1 administered intramuscularly. Some of the volunteers will receive a booster vaccination with MVA AMA1 administered via intramuscular route. Safety data will be collected for each of the eight regimens. Secondary aims of this study will be to assess the immune responses generated by each of these regimes.
AMA1 is a type I integral membrane protein. It is produced by mature P. falciparum schizonts in infected erythrocytes AMA1 has become a leading candidate vaccine antigen. This is based on several facts, most notably that in several field studies an association was found between antibodies to the ectodomain of AMA1 and protection against clinical malaria. Also, in the Gambia, presence of antibodies to AMA1 and MSP-1 has been shown to enhance clearance of chloroquine resistant parasites in vivo.
There are a number of trials currently ongoing in Oxford which are aimed at examining a simian adenovirus as a delivery vehicle and liver and blood stage malaria antigens as inserts. AdCh63 is currently in use with the MSP-1 insert, a blood stage antigen, in a phase I dose escalation clinical trial in Oxford (VAC037 / GTAC 166). The trial design includes AdCh63 MSP-1 administered alone and with MVA MSP-1 as part of a heterologous prime boost schedule, with sporozoite challenge of 3 volunteers in the higher dose group. At the most recent interim analysis, AdCh63 MSP-1 demonstrates an excellent safety profile.
Also, AdCh63 is currently in use with the ME-TRAP insert, a liver stage antigen in a phase I dose escalation clinical trial in Oxford, (VAC033 / GTAC133) and a phase I/IIa trial with sporozoite challenge (MAL034 / OXREC: 09/H064/9). AdCh63 ME-TRAP has been administered alone and with MVA ME-TRAP as part of a heterologous prime boost schedule at various doses with excellent safety and immunogenicity to 87 volunteers at time of interim analysis.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's planned enrollment of 16 is below the median of 220 across 1,027 interventional studies indexed under Malaria.
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Healthy adults aged 18 to 50 years
Exclusion Criteria:
Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
AdCh63 AMA1
Biological: AdCh63 AMA1
AdCh63 AMA1 followed by MVA AMA1
Biological: AdCh63 AMa1 and MVA AMA1
Group 1A - single dose of AdCH63 AMA1 5x10\^9 vp intramuscularly Group 2A - single dose of AdCH63 AMA1 5x10\^10 vp intramuscularly
Also known as: Simian adenovirus expressing malaria antigen AMA1
Group 1B - single dose of AdCH63 AMA1 5x10\^9 vp intramuscularly and single dose of MVA AMA1 5x10\^8 pfu 8 weeks later intramuscularly Group 2B - single dose of AdCH63 AMA1 5x10\^10 vp intramuscularly and single dose of MVA AMA1 5x10\^8 pfu 8 weeks later intramuscularly
Also known as: Simian adenovirus, modified vaccinia Ankara virus expressing malaria antigen AMA1
Safety of AdCh63 administered alone, and combinedwith MVA AMA1
To assess the safety in healthy volunteers of two candidate malaria vaccines, AdCh63 AMA1 with MVA AMA1 in a prime-boost regimen. The safety of AdCh63 administered alone, and combined with MVA AMA1 will be assessed. The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.
Time frame: Up to 6 months following the last vaccination
The level of immune response induced by vaccination with AdCh63 AMA1, when administered as a single vaccination and sequentially with MVA AMA1
To assess the level of immune response induced by vaccination with AdCh63 AMA1, when administered as a single vaccination and sequentially with MVA AMA1
Time frame: Up to 6 moths following the last vaccination
This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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University of Oxford