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COVID-19 Booster Vaccination in Persons With Multiple Sclerosis

NCT05081271 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-11-21

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

Homologous booster

Group 1 will receive a booster dose of a homologous vaccine and Group 2 a heterologous vaccine. This means Ad26.COV2.S if they originally received BNT162b2 or mRNA-1273 or vice versa

BIOLOGICAL

Heterologous booster

Group 1 will receive a booster dose of a homologous vaccine and Group 2 a heterologous vaccine. This means Ad26.COV2.S if they originally received BNT162b2 or mRNA-1273 or vice versa

Sponsors & Collaborators

  • Yale-Griffin Prevention Research Center

    collaborator OTHER

  • Multiple Sclerosis Treatment Center

    collaborator UNKNOWN

  • Griffin Hospital

    lead OTHER

Principal Investigators

  • Joseph B Guarnaccia, MD · Griffin Hospital

  • Frederick Browne, MD · Griffin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2022-05-30
Completion
2022-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05081271 on ClinicalTrials.gov