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Effect of Disease Modifying Therapy on Antibody Response to COVID19 Vaccination in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT04834401
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Matthew A. Tremblay, St. Barnabas Medical Center

Brief Summary:
This observational study is intended to evaluate the effect of disease modifying therapies on antibody responses to the mRNA-1273 vaccine (Moderna) for COVID-19. We hypothesize that the use of certain disease modifying therapies, particularly ocrelizumab, will mute and/or shorten the duration of humoral response to mRNA vaccines.

Condition or disease
Multiple Sclerosis Covid19

Detailed Description:
COVID-19 is a potentially fatal respiratory illness, caused by the novel coronavirus, SARS-CoV-2, which developed into a pandemic claiming the lives of over 500,000 people in the United States and over 2.5 million worldwide. Antibodies against the spike glycoprotein are believed to confer immunity to SARS-CoV-2. Multiple sclerosis (MS) is an autoimmune disease of the central nervous system, which is typically treated with immunomodulating medications, referred to as disease modifying therapies (DMTs). Some DMTs resulted in a diminished capacity to develop antibodies against natural infection with SARS-CoV-2. This study is designed to evaluate and compare the effect of DMTs on antibody response to mRNA vaccines for COVID-19. Serum samples will be collected from 30 participants per treatment arm at 8 weeks, 24 weeks, 48 weeks, and 72 weeks following vaccination with mRNA-1273. Geometric mean titers of anti-SARS-CoV-2 spike IgG will be measured to evaluate and compare peak antibody titers, as well as the duration of antibody response. The results will likely impact clinical decision-making, and guide treatment strategies for safely managing MS during the ongoing pandemic.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Effect of Disease Modifying Therapy on Antibody Response to COVID19 Vaccination in People With Multiple Sclerosis
Actual Study Start Date : March 22, 2021
Estimated Primary Completion Date : February 15, 2023
Estimated Study Completion Date : April 15, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Natalizumab
Natalizumab (minimum of 6 doses at standard interval)
Fumarates
Fumarates (dimethyl fumarate or diroximel fumarate)
Interferon Beta 1a
Interferon Beta 1a (or pegylated Interferon Beta-1a)
Ocrelizumab
Ocrelizumab (minimum of 2 full cycles of 600mg)



Primary Outcome Measures :
  1. Geometric mean titers (GMT) of anti-SARS-CoV-2 spike IgG for each treatment at 8 weeks from initial vaccination dose [ Time Frame: 8 weeks ]
    Serum Sample


Secondary Outcome Measures :
  1. Proportion of participants with >4 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks [ Time Frame: 8 weeks ]
    Serum sample

  2. Proportion of participants with >2 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks [ Time Frame: 8 weeks ]
    Serum Sample

  3. Median time from peak to complete absence of anti-SARS-CoV-2 IgG for each treatment arm [ Time Frame: 18 months ]
    Serum Sample


Other Outcome Measures:
  1. Proportion of participants with known vaccine-related side effects [ Time Frame: 8 weeks ]
    Questionnaire

  2. COVID-19 Infections [ Time Frame: 18 months ]
    Number of participants with PCR-confirmed COVID-19 infection following vaccination

  3. Effect of Duration of DMT use on Humoral Response to mRNA-1273 [ Time Frame: 8 week ]
    Correlation between duration of DMT and GMT values for SARS-CoV-2 IgG within each treatment arm


Biospecimen Retention:   Samples Without DNA
Serum will be stored for up to 2 years from enrollment


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Participants will be identified from the MS Center utilizing the electronic medical record, clinic visits or telephone encounters related to COVID-19 vaccination and recruited consecutively. Patients who appear to meet eligibility criteria will be contacted by research staff and offered informed consent using the Multiple Sclerosis Comprehensive Care Center standard protocol. If possible the baseline serum sample will be collected at the initial research visit, following the informed consent process.
Criteria

Inclusion Criteria:

  1. Men and women aged 18 to 65 years inclusive
  2. Patients who have signed written informed consent.
  3. Patients stable on current MS DMT for >6 months including:

    • Natalizumab (received a minimum of 6 doses per USPI)
    • Fumarates (dimethyl fumarate or diroximel fumarate)
    • Interferon Beta 1a (or pegylated Interferon Beta-1a)
    • Ocrelizumab (received a minimum of 2 full cycles per USPI)

Exclusion Criteria:

  1. Known history of SARS-CoV-2 infection
  2. Is pregnant or breastfeeding
  3. ≤6 months on current therapy (MS Participants)
  4. Participation in another investigational study
  5. Recent immunization with a non-COVID vaccine (within 4 weeks)
  6. Known or suspected allergy or history of anaphylaxis or other significant adverse reaction to the COVID-19 vaccine or its excipients
  7. Absolute lymphocyte count <0.5 x 10^9/L
  8. Concurrent Intravenous or Subcutaneous Immunoglobulin treatment (IVIG/SCIG)
  9. Received systemic corticosteroids < 30 days prior to Vaccine Dose 1

Visit and Assessment Schedule:

Participants will agree to five visits during the study and serum will be collected at the following time points:

  • Baseline/Screening visit
  • 8 weeks after 1st dose/4 weeks after 2nd dose (+/- 1 week)
  • 24 weeks (+/- 2 weeks)
  • 48 weeks (+/- 4 weeks)
  • 72 weeks (+/- 4 weeks)

Approximately 20ml of blood will be collected per patient per each visit.

Data Collection Plan and Patient Privacy Protection Prior to any testing under this protocol, including screening tests and assessments, candidates must also provide all authorizations required by local law (e.g., PHI authorization in North America).

The subject will not be identified by name in the CRF or in any study reports, and these reports will be used for research purposes only. Ethics committees and various government health agencies may inspect the records of this study. Every effort will be made to keep the subject's personal medical data confidential.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04834401


Contacts
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Contact: Phoebe DelBoccio 973-322-7046 phoebe.delboccio@rwjbh.org

Locations
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United States, New Jersey
Saint Barnabas Medical Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Phoebe DelBoccio    973-322-7046    phoebe.delboccio@rwjbh.org   
Principal Investigator: Matthew A Tremblay, MD         
Sponsors and Collaborators
St. Barnabas Medical Center
Investigators
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Principal Investigator: Matthew A Tremblay, MD, PhD RWJBarnabas Health
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Responsible Party: Matthew A. Tremblay, Director of Multiple Sclerosis Research, St. Barnabas Medical Center
ClinicalTrials.gov Identifier: NCT04834401    
Other Study ID Numbers: US-TYS-11909
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew A. Tremblay, St. Barnabas Medical Center:
mRNA vaccine
Ocrelizumab
Natalizumab
Dimethyl Fumarate
Diroximel Fumarate
Interferon Beta
SARS-CoV-2
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases