Status:
COMPLETED
Effect of Disease Modifying Therapy on Antibody Response to COVID19 Vaccination in Multiple Sclerosis
Lead Sponsor:
St. Barnabas Medical Center
Conditions:
Multiple Sclerosis
Covid19
Eligibility:
All Genders
18-65 years
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...
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 ove...
Eligibility Criteria
Inclusion
- Men and women aged 18 to 65 years inclusive
- Patients who have signed written informed consent.
- 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
- Known history of SARS-CoV-2 infection
- Is pregnant or breastfeeding
- ≤6 months on current therapy (MS Participants)
- Participation in another investigational study
- Recent immunization with a non-COVID vaccine (within 4 weeks)
- Known or suspected allergy or history of anaphylaxis or other significant adverse reaction to the COVID-19 vaccine or its excipients
- Absolute lymphocyte count \<0.5 x 10\^9/L
- Concurrent Intravenous or Subcutaneous Immunoglobulin treatment (IVIG/SCIG)
- 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)
- 36 weeks (+/- 4 weeks)
- 48 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.
Key Trial Info
Start Date :
March 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 17 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04834401
Start Date
March 22 2021
End Date
May 17 2022
Last Update
August 18 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039