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NCT02780154

PfSPZ Challenge in Non-immune Adults in Baltimore, USA

Completed Phase 1 Last updated 28 January 2019
What this trial tests

Phase 1 trial testing PfSPZ (7G8) Challenge in Plasmodium Falciparum Infection in 30 participants. Completed in 15 December 2016.

Timeline
25 August 2016
Primary endpoint
15 December 2016
15 December 2016

Quick facts

Lead sponsorNational Institute of Allergy and Infectious Diseases (NIAID)
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment30
Start date25 August 2016
Primary completion15 December 2016
Estimated completion15 December 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 45, any sex, with Plasmodium Falciparum Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Dose-Dependent Infectivity of Aseptic, Purified, Cryopreserved Plasmodium falciparum 7G8 Sporozoites in Malaria-Naive Adults.
    Laurens MB, Berry AA, Travassos MA, Strauss K, et al · · 2019 · cited 26× · PMID 31419294 · DOI 10.1093/infdis/jiz410
  2. The Controlled Human Malaria Infection Experience at the University of Maryland.
    Friedman-Klabanoff DJ, Laurens MB, Berry AA, Travassos MA, et al · · 2019 · cited 18× · PMID 30675854 · DOI 10.4269/ajtmh.18-0476
  3. Immunoprofiles associated with controlled human malaria infection and naturally acquired immunity identify a shared IgA pre-erythrocytic immunoproteome.
    Berry AA, Obiero JM, Travassos MA, Ouattara A, et al · · 2021 · cited 6× · PMID 34518543 · DOI 10.1038/s41541-021-00363-y
  4. Controlled human malaria infection with NF54 and 7G8 strains elicit differential antibody responses to Plasmodium falciparum peptides.
    Friedman-Klabanoff DJ, Jensen TL, Lyke KE, Laurens MB, et al · · 2025 · PMID 41030440 · DOI 10.3389/fimmu.2025.1641280

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing