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NCT00427167 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909 Malaria Vaccine
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 300
- Enrollment target
NCT00427167 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 300 participants.
The verdict
NCT00427167, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 300 participants
- Enrollment target
Study Summary
This study will evaluate the safety and immune response of healthy volunteers to an experimental malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909. Malaria is an infection of red blood cells caused by a parasite, Plasmodium falciparum, that is spread by certain kinds of mosquitoes. Each year, about 1 million people are killed by malaria worldwide, most of them young children in Africa. AMA1 C1 may help block the malaria parasite from getting into red blood cells. The vaccine is mixed with Alhydrogel® (Registered Trademark), a material that is commonly added to vaccines to make them work better (also called an adjuvant). Besides evaluating the vaccine, this study will also test two solutions of an experimental adjuvant, CPG 7909-P and CPG 7909-S. Healthy people between 18 and 50 years of age may be eligible for this 7-month study. Participants are randomly assigned to one of four treatment groups (A, B, C or D below). All receive two vaccinations, given as a shot in the upper arm either 1 or 2 months apart, as shown: * Group A: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-P at Day 0 and Day 28 (1-month interval) * Group B: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-S at Day 0 and Day 28 (1-month interval) * Group C: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-P at Day 0 and Day 56 (2-month interval) * Group D: AMA1 CI/Alhydrogel® (Registered Trademark)/CPG 7909-S at Day 0 and Day 56 (2-month interval) Group A and B participants return to the clinic for checkups at 3, 7, and 14 days after each vaccination and again at months 2, 3, 4, 5, and 7. Group C and D participants come to the clinic at 3, 7, and 14 days after each vaccination and again at months 3, 4, 5, and 7. In addition to the vaccinations, the study includes the following procedures: * Photographs of the subject's arm where the vaccination is given if a rash develops. * Daily temperature and symptoms record for the first 6 days after each of the 2 vacci
Interventions
- BIOLOGICAL AMA1-C1/Alhydrogel + CPG 7909 (Saline)
- BIOLOGICAL AMA1-C1/Alhydrogel + CPG 7909 (Phosphate)
- DRUG AMA1-C1/Alhydrogel + CPG 7909
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2007-01-23 |
| Est. Completion | 2008-11-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00427167
The ClinicalTrials.gov registry entry for NCT00427167 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 300 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 3 interventions - of which AMA1-C1/Alhydrogel + CPG 7909 (Saline) is the first listed.
NCT00427167 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00427167 about?
NCT00427167 is a clinical study titled "Phase I Study of AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909 Malaria Vaccine". This study will evaluate the safety and immune response of healthy volunteers to an experimental malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909. Malaria is an infection of red blood cells caused by a parasite, Plasmodium falciparum, that is spread by certain kinds of mo...
What is the current status of trial NCT00427167?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2007-01-23. Estimated completion is 2008-11-05.
What interventions are being tested in trial NCT00427167?
The interventions under investigation include: AMA1-C1/Alhydrogel + CPG 7909 (Saline) (BIOLOGICAL), AMA1-C1/Alhydrogel + CPG 7909 (Phosphate) (BIOLOGICAL), AMA1-C1/Alhydrogel + CPG 7909 (DRUG).
Who is sponsoring clinical trial NCT00427167?
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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