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NCT01441167 · ClinicalTrials.gov registry record · Phase 1
Experimental PfSPZ Vaccine in Adults Without Malaria
A Phase 1 study of Malaria and Prevention and Control, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT01441167: Completed Phase 1 study of Malaria and Prevention and Control, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01441167 is a Phase 1 study of Malaria and Prevention and Control that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 64 participants, below the 256-participant average among 27 other Malaria trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01441167, a Phase 1 study of Malaria and Prevention and Control, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * Malaria parasites are carried by mosquitoes, which spread the infection by biting people. Currently, there is no effective malaria vaccine. However, studies show that volunteers bitten many times by mosquitoes that carry weakened malaria parasites could fight off getting sick with malaria when later exposed to normal malaria parasites. Malaria parasites are weakened by exposing them to radiation when they are in the stage of development called sporozoites . Only the mosquitoes are irradiated and study volunteers are not exposed to radiation. The radiation stops the parasites from being able to cause disease but still promote protection. For many years, it was not possible to give these sporozoites to people as a vaccine since they could not be adequately purified from the mosquito. Scientists have recently figured out how to produce and isolate the weakened sporozoites so that they can be given in an injected vaccine. This vaccine is known as the "PfSPZ vaccine". * A malaria challenge will be used to test whether the vaccine will prevent infection. In a malaria challenge, mosquitoes that have the malaria parasite will be allowed to bite a participant's arm. In the event that the vaccine does not work, the malaria parasite used for the challenge can be treated completely with common anti-malaria medications. Participants will be treated immediately if they develop malaria symptoms. Objectives: \- To test the safety and effectiveness of the PfSPZ vaccine. Eligibility: \- Healthy volunteers between 18 to 45 years of age. Design: * Participants will be screened with a physical exam, medical history, and blood tests. There will be five different groups of study participants, all of whom will be monitored with frequent blood tests. * Group 1 will have two vaccines with the lowest amount of the vaccine given 4 weeks apart, with regular clinic visits up to 24 weeks after the second vaccine. This group will not have a malaria challenge. * Group 2 will ha
Conditions Studied
Interventions
- BIOLOGICAL PfSPZ
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2011-09-14 |
| Est. Completion | 2013-06-05 |
| Phase | Phase 1 |
What the finished NCT01441167 record still lists
NCT01441167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 256-participant average among 27 other Malaria trials with a reported enrollment target (75% lower).
The record links to 3 conditions, with Malaria appearing as the primary indexed condition, and to 1 intervention - of which PfSPZ is the first listed.
NCT01441167 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01441167 about?
NCT01441167 is a clinical study titled "Experimental PfSPZ Vaccine in Adults Without Malaria". Background: * Malaria parasites are carried by mosquitoes, which spread the infection by biting people. Currently, there is no effective malaria vaccine. However, studies show that volunteers bitten many times by mosquitoes that carry weakened malaria parasites could fight off getting sick with mal...
What is the current status of trial NCT01441167?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2011-09-14. Estimated completion is 2013-06-05.
What conditions does trial NCT01441167 study?
This clinical trial studies the following conditions: Malaria, Prevention and Control, Acquired Immunity.
What interventions are being tested in trial NCT01441167?
The interventions under investigation include: PfSPZ (BIOLOGICAL).
Who is sponsoring clinical trial NCT01441167?
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 NCT01441167 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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Where NCT01441167's enrollment target sits among peer trials
64 16th of 27 higher than 12 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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