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NCT02773979

PfSPZ Challenge in Healthy Malaria-Naïve Adults in the United States

Completed Phase 1 Last updated 27 December 2019
What this trial tests

Phase 1 trial testing Chloroquine in Plasmodium Falciparum Infection in 28 participants. Completed in 22 January 2018.

Timeline
12 September 2016
Primary endpoint
22 January 2018
22 January 2018

Quick facts

Lead sponsorNational Institute of Allergy and Infectious Diseases (NIAID)
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment28
Start date12 September 2016
Primary completion22 January 2018
Estimated completion22 January 2018
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 phase I trial of the replication-intact PfSPZ Challenge vaccine given under CQ cover will enroll 28 healthy volunteers to receive PfSPZ or placebo, as well as suppressive doses of chloroquine (CQ)on varying schedules. 10 weeks post 3rd immunization subjects will be subjected to controlled human malarial infection. The primary objective of this study is to evaluate the safety and tolerability of escalating doses of Sanaria PfSPZ Challenge administered by DVI on varying schedules to healthy malaria-naïve adults taking suppressive doses of CQ (PfSPZ-CVac).

Publications & conference data

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

  1. PfSPZ-CVac efficacy against malaria increases from 0% to 75% when administered in the absence of erythrocyte stage parasitemia: A randomized, placebo-controlled trial with controlled human malaria infection.
    Murphy SC, Deye GA, Sim BKL, Galbiati S, et al · · 2021 · cited 51× · PMID 34048504 · DOI 10.1371/journal.ppat.1009594
  2. Sporozoite immunization: innovative translational science to support the fight against malaria.
    Richie TL, Church LWP, Murshedkar T, Billingsley PF, et al · · 2023 · cited 44× · PMID 37571809 · DOI 10.1080/14760584.2023.2245890
  3. Immune responses to malaria pre-erythrocytic stages: Implications for vaccine development.
    Abuga KM, Jones-Warner W, Hafalla JCR. · · 2021 · cited 14× · PMID 32981095 · DOI 10.1111/pim.12795
  4. <i>Plasmodium</i> 18S Ribosomal RNA Biomarker Clearance After Food and Drug Administration-Approved Antimalarial Treatment in Controlled Human Malaria Infection Trials.
    Chavtur C, Staubus WJ, Ho M, Hergott DEB, et al · · 2023 · cited 2× · PMID 37265668 · DOI 10.1093/ofid/ofad202

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