NIH Begins Study of COVID-19 Vaccine Third Dose for Patients With Autoimmune Disease

The National Institutes of Health (NIH) initiated a phase 2 clinical trial to assess the antibody response to an extra dose of COVID-19 vaccines among patients with autoimmune disease who had inadequate responses to their original COVID-19 vaccines.

The COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders trial initially will include people with multiple sclerosis, pemphigus, rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis. Immunosuppressive therapies for these conditions have been associated with lesser response to vaccines.

This trial is designed to determine if participants sustain a significantly better antibody response 4 weeks after receiving the extra vaccine dose than they did following their original vaccinations. The study will also include a test to examine if pausing immunosuppressive therapy for short periods before and after vaccination improves the antibody response to the extra dose of a COVID-19 vaccine.

Approximately 600 participants aged 18 years and older at 15 to 20 sites nationwide will be enrolled in this study. Participants must be taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA); methotrexate (MTX); or B cell-depleting drugs. The trial participants must have had a negative or suboptimal antibody response to 2 doses of the Moderna COVID-19 vaccine, 2 doses of the Pfizer-BioNTech COVID-19 vaccine, or 1 dose of the Johnson & Johnson COVID-19 vaccine, all received prior to enrollment.

All participants will receive an extra dose of the same COVID-19 vaccine they originally received. Those participants who are taking MMF/MPA or MTX will be randomized to continue taking their immunosuppressive medication without alteration or to pause their therapy medication for a short period before and after receiving the extra vaccine dose.

Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021.

The trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, and is being conducted by the NIAID-funded Autoimmunity Centers of Excellence, NIH said in a press release.

Additional information about the COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders trial, including the locations of study sites, is available in ClinicalTrials.gov under study identifier NCT05000216.

--Rebecca Mashaw

NIH launches study of extra COVID-19 vaccine dose in people with autoimmune disease. Bethesda, MD: National Institutes of Health; August 27, 2021. https://www.nih.gov/news-events/news-releases/nih-launches-study-extra-covid-19-vaccine-dose-people-autoimmune-disease. Accessed September 2, 2021.