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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (400% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00427167 record still lists
NCT00427167 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (400% higher).
The record links to 0 conditions, and to 3 interventions - of which AMA1-C1/Alhydrogel + CPG 7909 (Saline) is the first listed.
NCT00427167 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00427167's enrollment target sits among peer trials
300 124th of 2000 higher than 1,867 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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