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NCT02780154 · ClinicalTrials.gov registry record · Phase 1
PfSPZ Challenge in Non-immune Adults in Baltimore, USA
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02780154 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 30 participants.
The verdict
NCT02780154, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL PfSPZ (7G8) Challenge
- BIOLOGICAL PfSPZ (NF54) Challenge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-08-25 |
| Est. Completion | 2016-12-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02780154
The ClinicalTrials.gov registry entry for NCT02780154 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 2 interventions - of which PfSPZ (7G8) Challenge is the first listed.
NCT02780154 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02780154 about?
NCT02780154 is a clinical study titled "PfSPZ Challenge in Non-immune Adults in Baltimore, USA". 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 D...
What is the current status of trial NCT02780154?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2016-08-25. Estimated completion is 2016-12-15.
What interventions are being tested in trial NCT02780154?
The interventions under investigation include: PfSPZ (7G8) Challenge (BIOLOGICAL), PfSPZ (NF54) Challenge (BIOLOGICAL).
Who is sponsoring clinical trial NCT02780154?
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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