PfSPZ Challenge in Non-immune Adults in Baltimore, USA
Condition: Plasmodium Falciparum Infection
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomized and controlled human study to optimize controlled human
      malaria infection (CHMI) administered by direct venous inoculation (DVI). 36 healthy adults
      aged between 18 and 45 years, will be randomized to one of five groups and will be inoculated
      with PfSPZ Challenge DVI. Participation duration is estimated to be 2 months, while the study
      duration is planned to be 4 months. The primary objective of this study is to assess the
      safety and reactogenicity of PfSPZ Challenge administered by DVI using 7G8 and NF54 P.
      falciparum strains.
    

Detailed description: 
      The proposed study is a single center, randomized and controlled human study to optimize
      controlled human malaria infection (CHMI) administered by direct venous inoculation (DVI). 30
      to 36 participants will be randomized to one of five groups and will be inoculated with PfSPZ
      Challenge DVI. All participants recruited will be healthy adults aged between 18 and 45
      years. The study duration is 4 months, participation duration is estimated to be 2 months.
      Safety and infectivity data will be collected for each study product and dose-level. Sera
      will be collected at baseline and at study day 29 for antibody assays. Participants, and
      clinical and laboratory investigators will be blinded to group allocation. The study primary
      endpoint will be reached at study day 29, at which time an interim study report will be
      generated. The investigators, the sponsor, the data and statistical analysis team, and
      Sanaria staff will meet in person or by teleconference on day 43 to review infection,
      pre-patent period, and adverse event results. These results will be made available to members
      of the International PfSPZ Consortium (I-PfSPZ-C) and if required, to regulatory authorities,
      including the FDA, to facilitate other PfSPZ Challenge CHMI studies with the appropriate
      disclaimers. Participants will be followed as outpatients for malaria diagnosis, treatment
      and follow-up to study day 57. Malaria positivity will be determined by qPCR diagnostics with
      microscopy as a backup. Participants who test positive for malaria and those who remain
      negative at study day 29 will be treated with oral atovaquone-proguanil. The primary
      objective of this study is to assess the safety and reactogenicity of PfSPZ Challenge
      administered by DVI using 7G8 and NF54 P. falciparum strains. Secondary objectives are to 1)
      assess the infectivity of four escalating doses of direct venous inoculation (DVI) of the 7G8
      clone in comparison with an established dose (100% infective) DVI of the NF54 strain and 2)
      assess the time to malaria patency for escalating doses of the 7G8 clone compared to a single
      dose of the NF54 strain.
    

Intervention name(s): PfSPZ (7G8) Challenge; PfSPZ (NF54) Challenge
Intervention type(s): Biological; Biological
Intervention description(s): PfSPZ (7G8) is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.; PfSPZ (NF54) is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: 7G8 clone; NF54 strain; Non-immune; PCR; PfSPZ Challenge; Plasmodium falciparum; qPCR; Sporozoites