Participants will be followed for 13 months with preliminary results expected in November 2021.
A Michigan Medicine physician will co-lead a National Institutes of Health study of antibody response to an additional dose of the COVID-19 vaccine in people with autoimmune diseases who did not present a strong immune response to the first round of authorized vaccination.
The announcement comes just a few weeks after the FDA and Centers for Disease Control and Prevention recommended( that people who are moderately-to-severely immunocompromised receive a third dose of an mRNA COVID-19 vaccine. Despite making up less than 3% of the U.S. adult population, immunocompromised people account for nearly 45% of breakthrough COVID infections requiring hospitalization.
The trial will be co-led by Dinesh Khanna, M.B.B.S., M.Sc., the Frederick G.L. Huetwell professor of rheumatology and the director of the scleroderma program at Michigan Medicine. The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, is funding the Phase 2 trial.
“Although the FDA has recently approved booster vaccines for immunocompromised patients under emergency use authorization, there are several advantages for patients to participate in this 12-month adaptive trial design,” Khanna said. “It allows us to carefully evaluate if the patients respond to the booster vaccine, continue to assess for durability of the vaccine over time and assess risk of flare of the underlying autoimmune disease.”
The trial will include approximately 600 adult participants with one of five autoimmune diseases:
- Multiple Sclerosis
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus
- Systemic Sclerosis
Trial participants, who will be followed for 13 months, must be taking immunosuppressive therapies and have demonstrated poor antibody response to an authorized COVID-19 vaccine regimen. The research team will also examine whether pausing immunosuppressive medication improves immune response to the booster shot.
“To hold or withhold the immunosuppressive therapies is an important issue for patients with autoimmune disease,” Khanna said. “On one hand, it may improve the response to the booster, and on the other hand, it may lead to disease flare. This trial will carefully evaluate this in a controlled fashion.”
For more information about the COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders trial, go to ClinicalTrials.gov and use NCT05000216 as an identifier.
Department of Communication at Michigan Medicine