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NCT01001650 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial of the PfSPZ Vaccine
A Phase 1 study of Plasmodium Falciparum, sponsored by Sanaria.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT01001650: Completed Phase 1 study of Plasmodium Falciparum, sponsored by Sanaria.
NCT01001650 is a Phase 1 study of Plasmodium Falciparum that has completed, run by Sanaria. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01001650, a Phase 1 study of Plasmodium Falciparum, has completed, sponsored by Sanaria.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to determine the safety and tolerability of a non-replicating, metabolically active Plasmodium falciparum sporozoite (PfSPZ) vaccine in malaria-naïve healthy volunteers following multiple-dose subcutaneous (SC) or intradermal (ID) administration. In addition, the investigators wish to evaluate PfSPZ vaccine-mediated protection against P. falciparum challenge in the following 4 groups (see below) and compare protective efficacy of the PfSPZ vaccine when given by SC v ID administration in all these groups: * Group 1: 4 doses of 7,500 PfSPZ/immunization, * Group 2: 4 doses of 30,000 PfSPZ/immunization, * Group 3: 4 doses of 135,000 PfSPZ/immunization * Group 4: 4 or 6 doses of 135,000 PfSPZ/immunization. If \> 80% protective efficacy is not achieved in Groups 1, 2, or 3, volunteers in Group 4 will receive a fifth and sixth dose.
Conditions Studied
Interventions
- BIOLOGICAL Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation)
Study Locations (2)
Maryland
- The Center for Vaccine Development, University of Maryland (CVD/UMB) - Baltimore
- Naval Medical Research Center (NMRC) Clinical Trials Center, on the campus of the National Naval Medical Center (NNMC) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2009-04 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
What the finished NCT01001650 record still lists
NCT01001650 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 1 condition, with Plasmodium Falciparum appearing as the primary indexed condition, and to 1 intervention - of which Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation) is the first listed.
NCT01001650 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01001650 about?
NCT01001650 is a clinical study titled "Clinical Trial of the PfSPZ Vaccine". The purpose of this study is to determine the safety and tolerability of a non-replicating, metabolically active Plasmodium falciparum sporozoite (PfSPZ) vaccine in malaria-naïve healthy volunteers following multiple-dose subcutaneous (SC) or intradermal (ID) administration. In addition, the invest...
What is the current status of trial NCT01001650?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2009-04. Estimated completion is 2010-09.
What conditions does trial NCT01001650 study?
This clinical trial studies the following conditions: Plasmodium Falciparum.
What interventions are being tested in trial NCT01001650?
The interventions under investigation include: Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01001650?
This trial is sponsored by Sanaria, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01001650 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 NCT01001650's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 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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