Malaria Clinical Trial
Official title:
A Pilot Study to Optimise Controlled Human Malaria Infections Using Plasmodium Falciparum Sporozoites Administered by Needle and Syringe
This is an open label, human pilot study to optimise controlled human malaria infection (CHMI) administered by Plasmodium falciparum sporozoites (PfSPZ. Volunteers will be inoculated with PfSPZ Challenge. The route of administration and dose will vary in order to identify the optimal regimen that achieves the greatest infection rate in volunteers with Plasmodium falciparum. All volunteers recruited will be healthy adults aged between 18 and 45 years. Safety and infectivity data will be collected for each of the regimens.
Studies involving CHMI are a powerful tool for investigating malaria vaccine and
prophylactic drug efficacy.CHMI has now become established as a key tool to assess the
efficacy of novel malaria vaccines and drugs. As CHMI trials are carried out in a controlled
environment, they allow unprecedented detailed evaluation of parasite growth and
immunological responses, providing essential information for vaccine and drug development.
Out of three currently available methods of performing experimental human malaria infections
(blood stage infection, mosquito bites and sporozoite infection), experimental injection
directly by needle and syringe using aseptic, purified, cryopreserved sporozoites is, in
principle, the most accurate and practical way of dosing sporozoites for challenge studies.
Recently, Sanaria Inc have been able to overcome the technical issues associated with the
production of aseptic, purified, cryopreserved Plasmodium falciparum sporozoites. As a
result, an Investigational New Drug application (IND) was submitted to the U.S. Food and
Drug Administration in February 2009, and a Phase 1 clinical trial with experimental
challenge of volunteers was initiated in April 2009. Another trial sponsored by Sanaria to
find the dose of aseptic, purified, cryopreserved sporozoites that should be used for
experimental human malaria infections is currently ongoing with collaboration with the
Radboud University Nijmegen Medical Center, The Netherlands.
This trial will be the first time aseptic, purified, cryopreserved P. falciparum sporozoites
have been administered intramuscularly to humans.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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