The trial also will investigate whether pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine in this population.
The Phase 2 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.
MS and rheumatoid arthritis
The trial, COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, will initially include people with multiple sclerosis, pemphigus, rheumatoid arthritis, systemic lupus erythematosus or systemic sclerosis.
The immunosuppressive therapies commonly taken by people with these diseases have been associated with poor immune responses to vaccines.
The study will enroll approximately 600 participants aged 18+ at up to 20 sites across the US.
Participants will have had a negative or suboptimal antibody response to an authorized or approved COVID-19 vaccine: two doses from Moderna, two doses from Pfizer-BioNTech COVID-19, or one dose of Johnson & Johnson.
In August, the FDA gave Moderna authorization to administer a third dose for immunocompromised individuals aged 18+.
It has also given Pfizer/BioNTech authorization for a third dose for administration to individuals aged 12+ who have undergone solid organ transplantation or are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. The companies have submitted Phase 1 data to the US FDA to support evaluation of a booster dose (third dose) of their COVID-19 vaccine to a broader population.
Last week Johnson & Johnson announced data supporting the use of its COVID-19 vaccine as a booster shot, adding it was engaging with the FDA, EMA and other agencies regarding its use.
They also must be taking one of three immunosuppressive therapies: mycophenolate mofetil (MMF) or mycophenolic acid (MPA); methotrexate (MTX); or B cell- depleting drugs.
Participants will receive an extra dose of the same COVID-19 vaccine as they received originally. Then those participants who are taking MMF/MPA or MTX will be assigned at random either to continue taking their immunosuppressive medication or pause for a short period before and after the booster dose.
The goal of the study is to determine how many participants have a significantly better antibody response four weeks after receiving the extra vaccine dose than they did after their original vaccinations.
Preliminary results are expected in November 2021. Participants will be followed for 13 months in total.
Around 8% of Americans have an autoimmune disease, including a disproportionate number of people in the minority communities most severely impacted by COVID-19, according to the NIH.
"Researchers have reported higher rates of severe COVID-19 and death in people with autoimmune disease than in the general population. It is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.
"The results of recent studies indicate that giving an extra dose of an authorized COVID-19 vaccine to solid organ transplant recipients, who must take immunosuppressive medications, can improve the immune response to the vaccine in many of these individuals. A NIAID study is underway to investigate this further.
The recent findings in solid organ transplant recipients also suggest that an extra dose of a COVID-19 vaccine may help some people with autoimmune disease who take certain immunosuppressive medications. The Food and Drug Administration recently amended the emergency use authorizations for the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow the administration of an additional dose to solid organ transplant recipients and other people who have an equivalent level of immunocompromise."