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

Multiple Sclerosis Clinical Trial

Official title:

Evaluating the Effect of Disease Modifying Therapy on Antibody Response to COVID19 Vaccination in People With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04834401
• Other study ID #: US-TYS-11909
• Status: Completed
• Start date: March 22, 2021
• Est. completion date: May 17, 2022

Study information

• Verified date: August 2022
• Source: St. Barnabas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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, 36 weeks, and 48 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 17, 2022
• Est. primary completion date: May 17, 2022
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

• 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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Saint Barnabas Medical Center	Livingston	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
St. Barnabas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of participants with known vaccine-related side effects	Questionnaire	8 weeks
Other	COVID-19 Infections	Number of participants with PCR-confirmed COVID-19 infection following vaccination	18 months
Other	Effect of Duration of DMT use on Humoral Response to mRNA-1273	Correlation between duration of DMT and GMT values for SARS-CoV-2 IgG within each treatment arm	8 week
Primary	Geometric mean titers (GMT) of anti-SARS-CoV-2 spike IgG for each treatment at 8 weeks from initial vaccination dose	Serum Sample	8 weeks
Secondary	Proportion of participants with >4 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks	Serum sample	8 weeks
Secondary	Proportion of participants with >2 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks	Serum Sample	8 weeks
Secondary	Median time from peak to complete absence of anti-SARS-CoV-2 IgG for each treatment arm	Serum Sample	18 months
Secondary	Proportion of spike-specific T-cells/Total T cells	Whole Blood Sample	36 Weeks