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NCT05081271 · ClinicalTrials.gov registry record · Early Phase 1
COVID-19 Booster Vaccination in Persons With Multiple Sclerosis
A Early Phase 1 study, sponsored by Griffin Hospital.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT05081271: Clinical Trial Early Phase 1 study, sponsored by Griffin Hospital.
NCT05081271 is a Early Phase 1 study that was terminated before completion, run by Griffin Hospital. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05081271, a Early Phase 1 study, was terminated before completion, sponsored by Griffin Hospital.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The success of the U.S. vaccination program against SARS-Cov-2 is shown by a dramatic drop in infection rates, hospitalizations and deaths.However, it appears that many persons who take medications that chronically suppress the immune system do not produce neutralizing antibodies to COVID-19 proteins in response to vaccination. This group includes a significant number of persons with multiple sclerosis (PWMS), many of whom are on therapies that chronically suppress their immune function. It is unclear what advice clinicians should provide regarding COVID-19 precautions to patients who fail to develop detectable COVID-19 spike protein antibodies using standard commercially-available tests after a standard series of vaccination, or whether they should test for antibody responses to COVID-19 vaccines in the absence of guidelines. A key research question is whether, in the absence of stopping or reducing potentially immune-altering therapies, there is a way to increase the likelihood of a neutralizing antibody response to COVID-19 vaccination in PWMS who are taking immune suppressive medications.
Primary Outcome
Percentage of subjects who test positive for COVID-19 spike protein antibodies following a booster vaccination.
Interventions
- BIOLOGICAL Homologous booster
- BIOLOGICAL Heterologous booster
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-10-15 |
| Est. Completion | 2022-05-30 |
| Phase | Early Phase 1 |
Why NCT05081271 stopped before completion
NCT05081271 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Homologous booster is the first listed.
NCT05081271 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05081271 about?
NCT05081271 is a clinical study titled "COVID-19 Booster Vaccination in Persons With Multiple Sclerosis". The success of the U.S. vaccination program against SARS-Cov-2 is shown by a dramatic drop in infection rates, hospitalizations and deaths.However, it appears that many persons who take medications that chronically suppress the immune system do not produce neutralizing antibodies to COVID-19 protein...
What is the current status of trial NCT05081271?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2021-10-15. Estimated completion is 2022-05-30.
What interventions are being tested in trial NCT05081271?
The interventions under investigation include: Homologous booster (BIOLOGICAL), Heterologous booster (BIOLOGICAL).
Who is sponsoring clinical trial NCT05081271?
This trial is sponsored by Griffin Hospital, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05081271's enrollment target sits among peer trials
10 1628th of 2000 higher than 256 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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