Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01397227 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Immunogenicity, Tolerability and Safety of a Malaria Vaccine and Also Its Protective Efficacy in a Malaria Challenge Model
A Phase 1 study, sponsored by Crucell Holland.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01397227: Completed Phase 1 study, sponsored by Crucell Holland.
NCT01397227 is a Phase 1 study that has completed, run by Crucell Holland. The registered enrollment target is 36 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01397227, a Phase 1 study, has completed, sponsored by Crucell Holland.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of two dose levels (1x10\^10 and 5x10\^10 virus particles (vp)) of the adenovirus serotype (Ad) Ad35.CS.01/Ad26.CS.01 prime-boost malaria candidate vaccine, followed by an evaluation of the protective efficacy of the higher dose level in an experimental malaria challenge. The study will be in 3 phases: 1. a dose escalation / vaccination phase in which both dose levels will be tested 2. a malaria challenge phase in which only subjects receiving the Ad35.CS.01/Ad26.CS.01 5x10\^10 vp dose level, together with six infectivity control subjects, will be exposed to experimental challenge with Plasmodium falciparum 3. a long term follow up phase in which all subjects who received active vaccine from both dose levels and/or malaria challenge will be included
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Ad35.CS.01/Ad26.CS.01 low dose (1 x 10^10 vp)
- BIOLOGICAL Ad 35.CS.01/Ad 26.CS.01 high dose (5 x 10^10 vp)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01397227
The ClinicalTrials.gov registry entry for NCT01397227 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Crucell Holland, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01397227 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01397227 about?
NCT01397227 is a clinical study titled "A Study to Assess the Immunogenicity, Tolerability and Safety of a Malaria Vaccine and Also Its Protective Efficacy in a Malaria Challenge Model". The purpose of this study is to assess the safety, tolerability and immunogenicity of two dose levels (1x10\^10 and 5x10\^10 virus particles (vp)) of the adenovirus serotype (Ad) Ad35.CS.01/Ad26.CS.01 prime-boost malaria candidate vaccine, followed by an evaluation of the protective efficacy of the ...
What is the current status of trial NCT01397227?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2011-06. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01397227?
The interventions under investigation include: Placebo (BIOLOGICAL), Ad35.CS.01/Ad26.CS.01 low dose (1 x 10^10 vp) (BIOLOGICAL), Ad 35.CS.01/Ad 26.CS.01 high dose (5 x 10^10 vp) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01397227?
This trial is sponsored by Crucell Holland, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.