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NCT02773979 · ClinicalTrials.gov registry record · Phase 1
PfSPZ Challenge in Healthy Malaria-Naïve Adults in the United States
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT02773979 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 28 participants.
The verdict
NCT02773979, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
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).
Interventions
- OTHER Placebo
- DRUG Chloroquine
- BIOLOGICAL PfSPZ (NF54) Challenge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2016-09-12 |
| Est. Completion | 2018-01-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02773979
The ClinicalTrials.gov registry entry for NCT02773979 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02773979 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02773979 about?
NCT02773979 is a clinical study titled "PfSPZ Challenge in Healthy Malaria-Naïve Adults in the United States". 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...
What is the current status of trial NCT02773979?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2016-09-12. Estimated completion is 2018-01-22.
What interventions are being tested in trial NCT02773979?
The interventions under investigation include: Placebo (OTHER), Chloroquine (DRUG), PfSPZ (NF54) Challenge (BIOLOGICAL).
Who is sponsoring clinical trial NCT02773979?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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