Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab Treated With Ocrelizumab or Natalizumab

Completed

• Conditions: Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Multiple Sclerosis; Nervous System Diseases; Demyelinating Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System
• Interventions: Device: Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test; Device: T-Detect COVID T-cell blood test

• Registration Number: NCT04837651
• Lead Sponsor: Dragonfly Research, LLC

Brief Summary

The primary goal of this study is to provide additional data regarding B and T-cell mediated responses to COVID-19 vaccines in MS patients treated with OCR and to determine which clinical and paraclinical variables correlating with vaccine immunogenicity. B-cell mediated humoral responses and adaptive T-cell mediated cellular responses were measured in patients treated with OCR who received any of the available SARS-CoV-2 vaccines, 3-4 weeks after completion of vaccination.

Detailed Description

The purpose of this study is to see if patients on ocrelizumab (Ocrevus) produce a humoral and T-cell response to the coronavirus vaccine. Ocrelizumab depletes B-lymphocytes and has the potential to reduce the effectiveness of vaccines. The impact of ocrelizumab treatment on coronavirus vaccines is unknown.

Natalizumab (Tysabri) likely has a minimal impact the efficacy of vaccines. In this study the investigators will take blood samples in patients being treated with either ocrelizumab or natalizumab before and after vaccination with an FDA-authorized coronavirus (COVID-19) vaccine and compare the antibody response in both groups.

Study Timeline

• Study Start: 2021-03-02
• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-08
• Status Verified: 2021-07
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ocrelizumab Treated Multiple Sclerosis Patients	Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test	-
Ocrelizumab Treated Multiple Sclerosis Patients	T-Detect COVID T-cell blood test	-
Natalizumab Treated Multiple Sclerosis Patients	T-Detect COVID T-cell blood test	-
Natalizumab Treated Multiple Sclerosis Patients	Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test	-

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 B-cell response	Measured within 3-4 weeks of final COVID-19 vaccine dose	Production of SARS-CoV-2 antibodies in response to the COVID-19 vaccine in patients receiving treatment with ocrelizumab or natalizumab.
SARS-CoV-2 T-cell response	Measured within 3-4 weeks of final COVID-19 vaccine dose	Production of SARS-CoV-2 T-cell response to the COVID-19 vaccine in patients receiving treatment with ocrelizumab or natalizumab.

Trial Locations

Locations (1)

Dragonfly Research, LLC; 🇺🇸 Wellesley, Massachusetts, United States