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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 is a Early Phase 1 study that was terminated before completion, run by Griffin Hospital. The registered enrollment target is 10 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05081271
The ClinicalTrials.gov registry entry for NCT05081271 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Griffin Hospital, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Homologous booster is the first listed.
NCT05081271 reports 0 study locations.
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.
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