Multiple SclerosisOCR-VAXNCT04837651
Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab Treated With Ocrelizumab or Natalizumab
An observational study of Multiple Sclerosis and Demyelinating Autoimmune Diseases, CNS, run by Dragonfly Research, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System
- What is being tested?
- Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test and T-Detect COVID T-cell blood test
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2021to 1 Jul 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult Multiple Sclerosis patients receiving treatment with natalizumab or ocrelizumab at the Elliot Lewis MS Center.
Who may be able to join
- Age 18-55
- Diagnosis of multiple sclerosis (as per the revised 2017 criteria)
- EDSS score of 0-5.5 inclusive
- Has initiated ocrelizumab or natalizumab at least 6 months prior to study enrollment
- For women of childbearing potential: agreement to remain abstinent or to use a highly effective (99% efficacy or greater) contraceptive method
- Individual must be able to provide consent, read/write/comprehend English language or must be able to provide a consistent translator
Who cannot join
- Previous infection with COVID-19, confirmed by FDA approved testing
- Cognitive impairment limiting the ability to consent or complete study procedures
- Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
- Any prior use of immunosuppressive or chemotherapy treatment (including, but not limited to, cladribine, alemtuzumab, mycophenolate mofetil, cyclophosphamide, methotrexate, azathioprine)
- Prior treatment with a B-cell depleting therapy other than ocrelizumab within 12 months of first on-study infusion excluding standard ocrelizumab pre-treatment therapy
- Use of systemic corticosteroid therapy within 12 weeks of screening (excluding corticosteroid treatment given concurrently with ocrelizumab)
- History of allergic reactions to vaccines
Trial locations and contacts
1 site in 1 country.
United States1 site
Dragonfly Research, LLC
Wellesley, Massachusetts, 02481
About this study
Official title: A Real World, Prospective, Single-center, Observational Study Comparing Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab or Natalizumab
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System, Nervous System Diseases, Demyelinating Diseases, Autoimmune Diseases
- Being tested
- Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test, T-Detect COVID T-cell blood test
- Keywords
- COVID-19, Natalizumab, Ocrelizumab, Ocrevus, Tysabri, Antibody, Coronavirus, Vaccine
- Medical subject headings
- Multiple Sclerosis, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System, Nervous System Diseases, Demyelinating Diseases, Autoimmune Diseases, Immune System Diseases, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elecsys semi-quantitative Anti-SARS-CoV-2 antibody testDevice
Subjects will receive an Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test within 4 weeks of receiving their first COVID-19 injection. Within 3-4 weeks of receipt of their final COVID-19 vaccine dose, subjects will receive another Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test.
T-Detect COVID T-cell blood testDevice
A select number of subjects will also receive a qualitative SARS-CoV-2 t-cell immunity test, the T-Detect COVID test, within 3-4 weeks of receipt of their final COVID-19 vaccine dose.
| Study group | Role | What they receive |
|---|---|---|
| Ocrelizumab Treated Multiple Sclerosis Patients | Not described Receives: Device: Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test; Device: T-Detect COVID T-cell blood test | |
| Natalizumab Treated Multiple Sclerosis Patients | Not described Receives: Device: Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test; Device: T-Detect COVID T-cell blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 B-cell response
Production of SARS-CoV-2 antibodies in response to the COVID-19 vaccine in patients receiving treatment with ocrelizumab or natalizumab.
Measured: Measured within 3-4 weeks of final COVID-19 vaccine dose
SARS-CoV-2 T-cell response
Production of SARS-CoV-2 T-cell response to the COVID-19 vaccine in patients receiving treatment with ocrelizumab or natalizumab.
Measured: Measured within 3-4 weeks of final COVID-19 vaccine dose
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 start2 Mar 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dragonfly Research, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Katz, M.D., Principal investigator, Dragonfly Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837651
- Sponsor's protocol ID
- VA26843
- Acronym
- OCR-VAX
- Status last verified
- Jul 2021
- First submitted
- 16 Mar 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World, Prospective, Single-center, Observational Study Comparing Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab or Natalizumab
- ClinicalTrials.gov ID
- NCT04837651
- Acronym / sponsor ID
- OCR-VAX / VA26843
- Conditions
- Multiple Sclerosis, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System, Nervous System Diseases, Demyelinating Diseases, Autoimmune Diseases
- Keywords
- COVID-19, Natalizumab, Ocrelizumab, Ocrevus, Tysabri, Antibody, Coronavirus, Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dragonfly Research, LLCUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ocrelizumab Treated Multiple Sclerosis Patients | – | Device: Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test, Device: T-Detect COVID T-cell blood test |
| Natalizumab Treated Multiple Sclerosis Patients | – | Device: Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test, Device: T-Detect COVID T-cell blood test |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult Multiple Sclerosis patients receiving treatment with natalizumab or ocrelizumab at the Elliot Lewis MS Center.
Key inclusion criteria (6 listed)
- Age 18-55
- Diagnosis of multiple sclerosis (as per the revised 2017 criteria)
- EDSS score of 0-5.5 inclusive
- Has initiated ocrelizumab or natalizumab at least 6 months prior to study enrollment
- For women of childbearing potential: agreement to remain abstinent or to use a highly effective (99% efficacy or greater) contraceptive method
Key exclusion criteria (7 listed)
- Previous infection with COVID-19, confirmed by FDA approved testing
- Cognitive impairment limiting the ability to consent or complete study procedures
- Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
- Any prior use of immunosuppressive or chemotherapy treatment (including, but not limited to, cladribine, alemtuzumab, mycophenolate mofetil, cyclophosphamide, methotrexate, azathioprine)
- Prior treatment with a B-cell depleting therapy other than ocrelizumab within 12 months of first on-study infusion excluding standard ocrelizumab pre-treatment therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elecsys semi-quantitative Anti-SARS-CoV-2 antibody testSubjects will receive an Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test within 4 weeks of receiving their first COVID-19 injection. Within 3-4 weeks of receipt of their final COVID-19 vaccine dose, subjects will receive another Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test. | Device | Natalizumab Treated Multiple Sclerosis Patients, Ocrelizumab Treated Multiple Sclerosis Patients |
| T-Detect COVID T-cell blood testA select number of subjects will also receive a qualitative SARS-CoV-2 t-cell immunity test, the T-Detect COVID test, within 3-4 weeks of receipt of their final COVID-19 vaccine dose. | Device | Natalizumab Treated Multiple Sclerosis Patients, Ocrelizumab Treated Multiple Sclerosis Patients |
Primary outcome
SARS-CoV-2 B-cell response
Time frame: 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
Time frame: 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.
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 2 Aug 2021.
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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.
Joshua Katz, M.D. principal investigator
Dragonfly Research, LLC
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 Demyelinating Autoimmune Diseases, CNS, run by Dragonfly Research, LLC 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 6 inclusion and 7 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 2 Aug 2021. 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?
SARS-CoV-2 B-cell response (time frame: Measured within 3-4 weeks of final COVID-19 vaccine dose). The study lists 2 primary outcomes in all. 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 2 Aug 2021.