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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: Completed Phase 1 study of Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Subjects will be monitored for 30 minutes following each immunization. Subjects will return to the clinic on Days 3,7,14 and 28 following each vaccination for clinical assessments, and periodically thereafter until completion
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 |
What the finished NCT01434381 record still lists
NCT01434381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 257-participant average among 27 other Malaria trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01434381's enrollment target sits among peer trials
30 22nd of 27 higher than 5 of 27 other Malaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malaria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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