COVID-19 Vaccine Trial Testing Extra Dose in MS, Other Diseases

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by Steve Bryson, PhD |

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A new clinical trial launched by the National Institutes of Health (NIH) is evaluating the impact of an extra dose of an approved or authorized COVID-19 vaccine in people with multiple sclerosis (MS) and other autoimmune diseases who did not properly respond to an original vaccine regimen.

Approximately 600 people will be enrolled in the Phase 2 trial (NCT05000216) — officially called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders. The study is open to people with MS as well as those with other autoimmune disorders, namely rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis (scleroderma), and pemphigus, which is a rare group of blistering diseases.

Information regarding contacts and study locations, expected at 15 to 20 sites across the U.S., can be found here. Several already are recruiting.

“Many people who have an autoimmune disease that requires immunosuppressive therapy have had a poor immune response to the authorized and approved COVID-19 vaccines, placing these individuals at high risk for the disease,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), said in a NIH press release.

“We are determined to find ways to elicit a protective immune response to the vaccines in this population,” Fauci said. “This new study is an important step in that direction.”

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Researchers note that many autoimmune conditions, including MS, are commonly treated with immunosuppressive therapies, which have been associated with poor immune responses to vaccines, including those for COVID-19.

Moreover, some studies suggest people with autoimmune disease have higher rates of severe COVID-19 compared with the general population. Still, it is unknown whether this is related to the autoimmune disease, the use of immunosuppressive medications, or both.

The U.S. Food and Drug Administration recently authorized an extra COVID-19 vaccine dose — either the Pfizer-BioNTech or Moderna COVID-19 vaccines — for solid organ transplant recipients, who also receive immunosuppressive medications, as well as those who have an equivalent level of immunocompromise. That approval was based on findings that showed the extra dose helped improve immune responses to the vaccines in these patients.

The new, nationwide trial is expected to enroll patients ages 18 and older who had a negative or poor antibody response following two doses of the Pfizer-BioNTech or Moderna COVID-19 vaccines and one dose of the Johnson & Johnson vaccine. The extra dose will be the same COVID-19 vaccine as they first received.

All eligible participants must be receiving one of three immunosuppressive medications, including mycophenolic acid (MPA) or mycophenolate mofetil (MMF), methotrexate (MTX), or therapies that actively deplete antibody-producing B-cells.

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The study also will assess whether pausing these immunosuppressive therapies will improve the antibody response to an extra vaccine dose. Participants taking MPA/MMF or MTX will be randomly assigned to continue their immunosuppressive medication or to pause their regimen for a short period before and after the extra vaccine dose.

The primary goal is to determine the proportion of patients with a significantly better antibody response about one month (four weeks) after receiving the extra dose, as compared with their response after their initial vaccine regimen. Participants will be followed for 13 months (just over a year).

The early results of the trial are expected later this year — by November, according to the NIAID.

The NIAID, part of NIH, is sponsoring the trial, which is being conducted by the NIAID-funded Autoimmunity Centers of Excellence.

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