Optimisation of Controlled Human Malaria Infection Using Sporozoites Administered by Needle and Syringe
Condition: Malaria; Plasmodium Falciparum
MeSH terms: Infections; Malaria
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Plasmodium falciparum sporozoites 2sites; Plasmodium falciparum sporozoites 1 site; Plasmodium falciparum sporozoites 1site
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, 2,500 sporozoites, 50ulx2, 2 intradermal injection sites; Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, 2,500 sporozoites, 50ulx2, 2 intramuscular injection sites; Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, 25,000 sporozoites, 50ulx2, 2 intramuscular injection sites
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Malaria; Protozoan Infections; Parasitic Diseases; Malaria Challenge