Multiple SclerosisNCT04834401
Effect of Disease Modifying Therapy on Antibody Response to COVID19 Vaccination in Multiple Sclerosis
An observational study of Multiple Sclerosis and Covid19, run by St. Barnabas Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Covid19
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 17 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
About this study
Official title: Evaluating the Effect of Disease Modifying Therapy on Antibody Response to COVID19 Vaccination in People With Multiple Sclerosis
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.
Read the 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, 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.
- Conditions
- Multiple Sclerosis, Covid19
- Keywords
- mRNA vaccine, Ocrelizumab, Natalizumab, Dimethyl Fumarate, Diroximel Fumarate, Interferon Beta, SARS-CoV-2
- Medical subject headings
- Multiple Sclerosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titers (GMT) of anti-SARS-CoV-2 spike IgG for each treatment at 8 weeks from initial vaccination dose
Serum Sample
Measured: 8 weeks
Secondary outcomes (4)
Proportion of participants with >4 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks
Serum sample
Measured: 8 weeks
Proportion of participants with >2 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks
Serum Sample
Measured: 8 weeks
Median time from peak to complete absence of anti-SARS-CoV-2 IgG for each treatment arm
Serum Sample
Measured: 18 months
Proportion of spike-specific T-cells/Total T cells
Whole Blood Sample
Measured: 36 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start22 Mar 2021
- Primary completion17 May 2022
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Barnabas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew A. Tremblay, St. Barnabas Medical Center
- Investigators
- Matthew A Tremblay, MD, PhD, Principal investigator, RWJBarnabas Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834401
- Sponsor's protocol ID
- US-TYS-11909
- Status last verified
- Aug 2022
- First submitted
- 2 Apr 2021
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Disease Modifying Therapy on Antibody Response to COVID19 Vaccination in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04834401
- Acronym / sponsor ID
- US-TYS-11909
- Conditions
- Multiple Sclerosis, Covid19
- Keywords
- mRNA vaccine, Ocrelizumab, Natalizumab, Dimethyl Fumarate, Diroximel Fumarate, Interferon Beta, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- St. Barnabas Medical CenterUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Proportion of participants with >4 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks
Time frame: 8 weeks
Proportion of participants with >2 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks
Time frame: 8 weeks
Median time from peak to complete absence of anti-SARS-CoV-2 IgG for each treatment arm
Time frame: 18 months
Proportion of spike-specific T-cells/Total T cells
Time frame: 36 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew A Tremblay, MD, PhD principal investigator
RWJBarnabas Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Covid19, run by St. Barnabas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.