SUMMARY: Investigators nationwide are recruiting 900 adults living with multiple sclerosis and other disorders, and up to 300 children with multiple sclerosis for a clinical trial to assess immune system responses to extra dose(s) of the authorized COVID-19 vaccines.
Adult participants are people with one of five autoimmune diseases (MS, pemphigus, rheumatoid arthritis, systemic lupus erythematosus or systemic sclerosis) who did not mount a robust antibody response to an original vaccine regimen. A second stage is enrolling people who did not mount a robust antibody response to their 3
rd dose of vaccine (booster). The pediatric study is enrolling children and teens with MS, juvenile systemic lupus erythematosus, juvenile idiopathic arthritis, and juvenile dermatomyositis. The study is funded by the National Institute of Health’s National Institute of Allergy and Infectious Diseases.
Learn more about COVID-19 and MS
Rationale: People living with MS taking certain disease-modifying therapies (ocrelizumab, rituximab, ofatumumab, and possibly fingolimod, siponimod, ozanimod, ponesimod and others) may have a reduced and possibly undetectable antibody response to the COVID-19 vaccines. Antibodies are proteins produced by the immune system and the presence of anti-COVID-19 antibodies is one indication that the vaccine is providing protection from the virus.
Recent research indicates the effectiveness of giving an extra dose of an authorized COVID-19 vaccine to people who underwent organ transplants and are taking immune-suppressing medications. This suggests that an extra dose of a COVID-19 vaccine may help people with MS (and other diseases) who take certain immune-suppressing medications. Additional doses of vaccines have been approved by the U.S. Food and Drug Administration for solid organ transplant recipients and other people who are similarly immunocompromised.
Eligibility and Details:
All participants with MS (adult and pediatric) must be taking one of these therapies: B cell-depleting treatments within the past 18 months (such as rituximab, ocrelizumab, ofatumumab.
Adult Study:
- Stage I participants are people living with MS (and other diseases) aged 18 years and older who have had a negative or suboptimal antibody response to two doses of the Moderna COVID-19 vaccine or two doses of the Pfizer-BioNTech COVID-19 vaccine. Participants will receive an extra dose of the same COVID-19 vaccine as they received originally.
- Participants eligible for Stage II have received a 3rd dose of vaccine (using the same vaccine they received for their first vaccine series), are 18 years and older who have had a negative or suboptimal antibody response. Participants who received the Johnson & Johnson vaccine for their initial doses will receive a dose of Moderna vaccine. Participants who received Pfizer or Moderna vaccine for their initial doses will choose to receive the alternate mRNA vaccine (ex. Pfizer patient will receive Moderna vaccine) or the Johnson & Johnson vaccine.Pediatric Study:
Pediatric Study:
Participants are people with pediatric-onset MS (and other diseases) aged 5 - 17 years who have had a negative or suboptimal antibody response to two doses of the Pfizer-BioNTech COVID-19 vaccine. As other vaccines become approved for ages 5-17 years, they will be added to the study. Participants will receive an extra dose of the same COVID-19 vaccine as they received originally.
The main goal of the study is to determine the proportion of participants who have a significantly better antibody response four weeks after receiving the extra vaccine dose than they did after their original vaccinations. All participants will receive their vaccine response titer results at each study visit after receiving their additional vaccine dose. Study participants will be followed for a total of 13 months.
What Else is Involved? The study involves up to 7-8 in-person visits to the study site over the course of 13 months. Each visit will involve blood draws, clinical exams, and responding to questionnaires.
Please note: This study requires in-person visits to the study site. Precautions are being taken to reduce the on-site risks of exposure to COVID-19.
Contact: To see if you are a good candidate for the ACV01 study and for site contact information, please visit the ACV01 public website:
https://www.autoimmunecovidbooster.org.
The following sites are enrolling people with MS:
Adult Sites:
- Oklahoma Medical Research Foundation (Oklahoma City, OK)
- Michigan Medicine (Ann Arbor, MI)
- University of Pennsylvania (Philadelphia, PA)
- Duke University (Durham, NC)
- Brigham & Women’s Hospital (Boston, MA)
- Washington University School of Medicine (St. Louis, MO)
- Cleveland Clinic Foundation (Cleveland, OH)
- Benaroya Research Institute (Seattle, WA)
- Columbia University (New York, NY)
Pediatric Sites:
- UNC Chapel Hill (Chapel Hill, NC)
- Nationwide Children’s Hospital (Columbus, OH)
- Duke University (Durham, NC)
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
Without participants in research studies, MS research would come to a standstill.
Read more here.