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NCT02015091 · ClinicalTrials.gov registry record · Phase 1
Study of Controlled Human Malaria Infections to Evaluate Protection After Intravenous or Intramuscular Administration of PfSPZ Vaccine in Malaria-Naive Adults
A Phase 1 study of Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 141
- Enrollment target
- 2
- Study locations
NCT02015091 is a Phase 1 study of Malaria that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 141 participants, below the 253-participant average among 27 other Malaria trials with a reported enrollment target (44% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT02015091, a Phase 1 study of Malaria, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 141 participants
- Enrollment target
- 2
- Study locations
Study Summary
Background: \- People bitten by mosquitoes carrying weakened malaria parasites could fight off the disease if later exposed to normal malaria parasites. Scientists have discovered how to make the weakened parasites, which can be injected by the PfSPZ vaccine. Researchers want to see if people who receive the vaccine get malaria after being bitten in a controlled setting (a controlled human malaria infection, CHMI). Objective: \- To see if the PfSPZ malaria vaccine is safe and prevents malaria in a controlled setting. Eligibility: \- Healthy adults 18 45 years old. Design: * Participants will be screened with medical history, physical exam, blood and lab tests, and EKG. * Participants will be split into 8 groups, to be in the study for 3 12 months. * Participants will receive 3 5 vaccinations, injected by a needle in an arm vein or muscle. * Participants will keep a health diary and be contacted by phone. * For CHMI, a cup with mosquitoes carrying malaria is applied to participants arm for 5 minutes. Five mosquitoes at a time are used, until 5 have bitten. Some groups will be exposed to malaria more than once. * After CHMI, participants will visit the clinic very frequently (including daily visits for 12 days) for 28 days. * Blood will be drawn at most visits, from 1 to 20 tubes. Physical exam and medical history may also be repeated * Participants who develop malaria will be treated immediately at the clinic. Standard treatment takes 72 hours. Malaria symptoms may last up to 3 days.
Conditions Studied
Interventions
- BIOLOGICAL PfSPZ Vaccine
Study Locations (2)
Maryland
- University of Maryland Center for Vaccine Dev, Baltimore - Baltimore
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2013-12-12 |
| Est. Completion | 2016-09-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02015091
The ClinicalTrials.gov registry entry for NCT02015091 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 253-participant average among 27 other Malaria trials with a reported enrollment target (44% lower). 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 1 condition, with Malaria appearing as the primary indexed condition, and to 1 intervention - of which PfSPZ Vaccine is the first listed.
NCT02015091 reports 2 study locations spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02015091 about?
NCT02015091 is a clinical study titled "Study of Controlled Human Malaria Infections to Evaluate Protection After Intravenous or Intramuscular Administration of PfSPZ Vaccine in Malaria-Naive Adults". Background: \- People bitten by mosquitoes carrying weakened malaria parasites could fight off the disease if later exposed to normal malaria parasites. Scientists have discovered how to make the weakened parasites, which can be injected by the PfSPZ vaccine. Researchers want to see if people who r...
What is the current status of trial NCT02015091?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 141 participants. The study started on 2013-12-12. Estimated completion is 2016-09-08.
What conditions does trial NCT02015091 study?
This clinical trial studies the following conditions: Malaria.
What interventions are being tested in trial NCT02015091?
The interventions under investigation include: PfSPZ Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02015091?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02015091 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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