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NCT00889616 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of the Safety and Immunogenicity of BSAM-2/Alhydrogel +CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium Falciparum Malaria in Adults in the US and Mali
A Phase 1 study of Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 154
- Enrollment target
- 2
- Study locations
NCT00889616: Completed Phase 1 study of Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00889616 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 154 participants, below the 252-participant average among 27 other Malaria trials with a reported enrollment target (39% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00889616, 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
- 154 participants
- Enrollment target
- 2
- Study locations
Study Summary
Background: * Globally, the Plasmodium falciparum parasite is responsible for at least 247 million acute cases of malaria each year, resulting in about 1 million deaths. Approximately 90 percent of these deaths, the majority in children under 5 years of age, occur in Africa due to infection with P. falciparum. * People living in endemic areas develop natural immunity to P. falciparum as a result of repeated infection. Consequently, children who survive to 5 years of age rarely succumb to life-threatening disease despite frequent infection. This acquired immunity is mediated in part by blood-stage parasite-specific antibodies. Thus, parasite proteins expressed during the blood-stage have been proposed as good candidates for inclusion in a vaccine. * A number of P. falciparum merozoite antigens have been identified as promising blood-stage vaccine candidates, including Merozoite Surface Protein 1 (MSP 1) and Apical Membrane Antigen 1 (AMA 1). This Phase I study is the first time that the combination vaccine (BSAM-2/Alhydrogel +CPG 7909) will be given to humans. The vaccine will be administered in a randomized, open-label (U.S.)/single-blinded (Mali), dose-escalating trial. Objectives: * To assess safety and reactogenicity of the combination vaccine (BSAM-2/Alhydrogel +CPG 7909) in malaria-naive U.S. adults and semi-immune Malian adults. * To determine the antibody response of the combination vaccine to the AMA 1 and MSP 142 proteins, as measured by antibody levels and parasite growth inhibition. * To determine the extent to which the antibody response to the individual antigens (AMA 1 and MSP 142) is correlated when the combination vaccine is given, and to determine T and B cell responses to vaccination. Eligibility: * United States: Healthy volunteers between 18 and 50 years, inclusive. Available for the 52 weeks of the trial and willing to participate in the study as evidenced by signing the informed consent document. * Mali: Healthy volunteers between 18 and 4
Conditions Studied
Interventions
- DRUG BSAM2/Alhydrogel + CPG 7909
Study Locations (2)
Maryland
- Johns Hopkins University - Baltimore
Other
- Malaria Research and Training Center - Bamako
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2009-04-23 |
| Est. Completion | 2012-07-18 |
| Phase | Phase 1 |
What the finished NCT00889616 record still lists
NCT00889616 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 252-participant average among 27 other Malaria trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Malaria appearing as the primary indexed condition, and to 1 intervention - of which BSAM2/Alhydrogel + CPG 7909 is the first listed.
NCT00889616 reports a single indexed study location in Maryland, Other.
Frequently Asked Questions
What is clinical trial NCT00889616 about?
NCT00889616 is a clinical study titled "Phase I Study of the Safety and Immunogenicity of BSAM-2/Alhydrogel +CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium Falciparum Malaria in Adults in the US and Mali". Background: * Globally, the Plasmodium falciparum parasite is responsible for at least 247 million acute cases of malaria each year, resulting in about 1 million deaths. Approximately 90 percent of these deaths, the majority in children under 5 years of age, occur in Africa due to infection with P....
What is the current status of trial NCT00889616?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 154 participants. The study started on 2009-04-23. Estimated completion is 2012-07-18.
What conditions does trial NCT00889616 study?
This clinical trial studies the following conditions: Malaria.
What interventions are being tested in trial NCT00889616?
The interventions under investigation include: BSAM2/Alhydrogel + CPG 7909 (DRUG).
Who is sponsoring clinical trial NCT00889616?
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 NCT00889616 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00889616's enrollment target sits among peer trials
154 8th of 27 higher than 19 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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