NCT02780154

PfSPZ Challenge in Non-immune Adults in Baltimore, USA

A Phase 1 Trial to Evaluate the Safety and Infectivity of Direct Venous Inoculation of Aseptic, Purified, Cryopreserved Plasmodium Falciparum (7G8 and NF54) Sporozoites in Non-immune Adults in Baltimore, USA

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Plasmodium Falciparum Infection

Interventions

Type	Name	Description
BIOLOGICAL	PfSPZ (7G8) Challenge	PfSPZ (7G8) is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.
BIOLOGICAL	PfSPZ (NF54) Challenge	PfSPZ (NF54) is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.

Timeline

• Start date: 2016-08-25
• Primary completion: 2016-12-15
• Completion: 2016-12-15
• First posted: 2016-05-23
• Last updated: 2019-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study