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NCT01169077 · ClinicalTrials.gov registry record · Phase 1
EP1300 Polyepitope DNA Vaccine Against Plasmodium Falciparum Malaria
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT01169077 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 39 participants.
The verdict
NCT01169077, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
Malaria, a disease responsible for over one million deaths per year, is caused by a germ spread by mosquito bites. The purpose of this study is to evaluate a vaccine designed for the prevention of malaria caused by the parasite, Plasmodium falciparum, and to evaluate the device used to give the vaccine. This study will provide information on how safe, effective, and tolerable the vaccine is in healthy adults. The participants will be assigned, by chance, to receive 3 doses/shots of the vaccine or a placebo (substance that contains no medication) by injection in the upper arm. Study participants will include 39 healthy adults aged 18-40 years who have not been exposed to malaria and who will enroll at the Emory Vaccine and Treatment Evaluation Unit in Atlanta, Georgia. Study procedures include physical exams and several blood samples. Participants will be involved in the study for approximately seven and one half months.
Interventions
- DRUG Placebo
- BIOLOGICAL EP-1300
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01169077
The ClinicalTrials.gov registry entry for NCT01169077 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 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 Placebo is the first listed.
NCT01169077 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01169077 about?
NCT01169077 is a clinical study titled "EP1300 Polyepitope DNA Vaccine Against Plasmodium Falciparum Malaria". Malaria, a disease responsible for over one million deaths per year, is caused by a germ spread by mosquito bites. The purpose of this study is to evaluate a vaccine designed for the prevention of malaria caused by the parasite, Plasmodium falciparum, and to evaluate the device used to give the vacc...
What is the current status of trial NCT01169077?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2010-08. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01169077?
The interventions under investigation include: Placebo (DRUG), EP-1300 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01169077?
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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