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NCT01434381 · ClinicalTrials.gov registry record · Phase 1
Initial Study of Malaria Vaccine Pfs25-EPA/Alhydrogel(Registered Trademark)
A Phase 1 study of Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01434381 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 30 participants, below the 257-participant average among 27 other Malaria trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01434381, 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
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- The malaria vaccine Pfs25-EPA/Alhydrogel may help block malaria parasites from developing in mosquitoes. When a mosquito bites a vaccinated person, the vaccine should prevent parasites from developing in the mosquito. As a result, the mosquito will not spread malaria to the next person it bites. However, the vaccine will not directly prevent people from getting sick with malaria. Researchers want to test the safety of and response to this vaccine. Objectives: \- To test the safety of the malaria vaccine Pfs25-EPA/Alhydrogel. Eligibility: \- Healthy volunteers between 18 and 50 years of age. Design: * Participants will be screened with a medical history, physical exam, and blood tests. * They will be assigned to a study group to have either two or three doses of the vaccine. Participants will have checkups after each dose of vaccine, * The additional doses will be given 2 months or 2 and 4 months after the first vaccine. * Participants will have regular blood tests to check the level of the response to the vaccine. * They will be followed for up to 1 year after the last vaccine to have any additional tests as needed.
Conditions Studied
Interventions
- BIOLOGICAL Pfs25-EPA/Alhydrogel
Study Locations (1)
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01434381
The ClinicalTrials.gov registry entry for NCT01434381 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, below the 257-participant average among 27 other Malaria trials with a reported enrollment target (88% 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 Pfs25-EPA/Alhydrogel is the first listed.
NCT01434381 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01434381 about?
NCT01434381 is a clinical study titled "Initial Study of Malaria Vaccine Pfs25-EPA/Alhydrogel(Registered Trademark)". Background: \- The malaria vaccine Pfs25-EPA/Alhydrogel may help block malaria parasites from developing in mosquitoes. When a mosquito bites a vaccinated person, the vaccine should prevent parasites from developing in the mosquito. As a result, the mosquito will not spread malaria to the next pers...
What is the current status of trial NCT01434381?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2011-08. Estimated completion is 2013-08.
What conditions does trial NCT01434381 study?
This clinical trial studies the following conditions: Malaria.
What interventions are being tested in trial NCT01434381?
The interventions under investigation include: Pfs25-EPA/Alhydrogel (BIOLOGICAL).
Who is sponsoring clinical trial NCT01434381?
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 NCT01434381 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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