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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). 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
Primary Outcome
Type and frequency of solicited local and systemic AEs to be recorded. Solicited AEs in the challenge period are collected via a reactogenicity checklist during study visits. Solicited AEs in the vaccination period are collected via a Subject Diary.
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 |
What the finished NCT01397227 record still lists
NCT01397227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01397227 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01397227's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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