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Vaccine-generated Immunity in Ocrelizumab-treated Patients: Longitudinal Assessments (VIOLA)

NCT04843774 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2023-11-08

No results posted yet for this study

Summary

Severe acute respiratory coronavirus 2 (SARS-CoV-2) is a novel coronavirus and the causative agent of COVID 19 disease, whose presentation symptoms range from asymptomatic infection to mild flu-like symptoms to multi system failure and death, resulting in significant morbidity and mortality worldwide. Novel vaccines against the SARS-CoV-2 virus have very recently been developed; however, the effectiveness, immune response, and short- or long-term safety of these vaccines have not been tested in immunocompromised patients on anti-CD-20 therapy for multiple sclerosis (MS) or for other disorders.

This study will examine the immune response of the Pfizer-BioNTech and Moderna messenger RNA (mRNA)-platform vaccines developed against SARS-CoV-2 virus given as standard of care (SOC) in MS patients on ocrelizumab.

Conditions

Interventions

DRUG

SARS-COV-2 mRNA Vaccine

Pfizer-BioNTech and Moderna messenger RNA (mRNA)-platform vaccines developed against SARS-CoV-2 virus will be given as standard of care (SOC)

Sponsors & Collaborators

Principal Investigators

  • Ilya Kister, MD · NYU Langone Health

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2023-04-18
Completion
2023-04-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT04843774 on ClinicalTrials.gov