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NCT01967238 · ClinicalTrials.gov registry record · Early Phase 1
An Open Label Study of IgG Fc Glycan Composition in Human Immunity
A Early Phase 1 study, sponsored by Rockefeller University.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 129
- Enrollment target
NCT01967238: Clinical Trial Early Phase 1 study, sponsored by Rockefeller University.
NCT01967238 is a Early Phase 1 study that was terminated before completion, run by Rockefeller University. The registered enrollment target is 129 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (143% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01967238, a Early Phase 1 study, was terminated before completion, sponsored by Rockefeller University.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 129 participants
- Enrollment target
Study Summary
In order to produce better more effective vaccines, it is important to understand the particulars of why individuals have an effective or ineffective immune response to vaccination. We are going to examine specific aspects of the antibody (IgG Fc glycan) made by healthy volunteers who receive different vaccines or who have a viral infection to understand the nature of an effective (or less effective) vaccine response. The results of this research could be used to develop adjuvants to increase/ improve vaccine response.
Primary Outcome
The percent of Fc glycans that are galactosylation, fucosylation and/or sialylation of pre- vs. post- vaccination Fcs determined by lectin blot (Erythrina cristagalli, Aleuria Aurantia Lectin and Sambucus nigra lectins specific for galactose, fucose and 2,6-sialic acid, respectively) or by mass spectrometric analysis. 100% of IgG were found to have these modifications.
Interventions
- BIOLOGICAL IM Pneumococcal, meningococcal, or flu vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2013-03 |
| Est. Completion | 2023-03 |
| Phase | Early Phase 1 |
Why NCT01967238 stopped before completion
NCT01967238 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (143% higher).
The record links to 0 conditions, and to 1 intervention - of which IM Pneumococcal, meningococcal, or flu vaccine is the first listed.
NCT01967238 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01967238 about?
NCT01967238 is a clinical study titled "An Open Label Study of IgG Fc Glycan Composition in Human Immunity". In order to produce better more effective vaccines, it is important to understand the particulars of why individuals have an effective or ineffective immune response to vaccination. We are going to examine specific aspects of the antibody (IgG Fc glycan) made by healthy volunteers who receive differ...
What is the current status of trial NCT01967238?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 129 participants. The study started on 2013-03. Estimated completion is 2023-03.
What interventions are being tested in trial NCT01967238?
The interventions under investigation include: IM Pneumococcal, meningococcal, or flu vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01967238?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01967238's enrollment target sits among peer trials
129 138th of 2000 higher than 1,862 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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