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NCT02601716 · ClinicalTrials.gov registry record · Phase 2
PfSPZ Vaccine: Dose Optimization With Heterologous Challenge in Healthy Malaria-Naïve Adults
A Phase 2 study, sponsored by Sanaria.
- Completed
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
NCT02601716: Completed Phase 2 study, sponsored by Sanaria.
NCT02601716 is a Phase 2 study that has completed, run by Sanaria. The registered enrollment target is 92 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02601716, a Phase 2 study, has completed, sponsored by Sanaria.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
Study Summary
This is an open-label evaluation of the safety, tolerability, immunogenicity and efficacy of PfSPZ Vaccine administered by direct venous inoculation (DVI) in healthy, malaria-naïve adult subjects.
Primary Outcome
Incidence and type of adverse events (including breakthrough infections), vital signs, clinical laboratory assessments, physical examination findings post first immunization onwards.
Interventions
- BIOLOGICAL PfSPZ Vaccine
- BIOLOGICAL CHMI (7G8)
- BIOLOGICAL CHMI (NF135.C10)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2016-01 |
| Est. Completion | 2017-11 |
| Phase | Phase 2 |
What the finished NCT02601716 record still lists
NCT02601716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 3 interventions - of which PfSPZ Vaccine is the first listed.
NCT02601716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02601716 about?
NCT02601716 is a clinical study titled "PfSPZ Vaccine: Dose Optimization With Heterologous Challenge in Healthy Malaria-Naïve Adults". This is an open-label evaluation of the safety, tolerability, immunogenicity and efficacy of PfSPZ Vaccine administered by direct venous inoculation (DVI) in healthy, malaria-naïve adult subjects.
What is the current status of trial NCT02601716?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2016-01. Estimated completion is 2017-11.
What interventions are being tested in trial NCT02601716?
The interventions under investigation include: PfSPZ Vaccine (BIOLOGICAL), CHMI (7G8) (BIOLOGICAL), CHMI (NF135.C10) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02601716?
This trial is sponsored by Sanaria, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02601716's enrollment target sits among peer trials
92 767th of 2000 higher than 1,230 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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