A phase II trial to study the immune response to an additional dose of a Covid-19 vaccine in autoimmune disease patients who did not respond to Moderna, Pfizer-BioNTech COVID-19 vaccines (two doses), or the single dose Johnson & Johnson vaccine has been launched by the National Institutes of Health (NIH). They would be given the same additional dose as their original vaccine. The initial results of the trial are expected to be released in November this year.

To start with, the trial will include patients with rheumatoid arthritis, multiple sclerosis, pemphigus, systemic sclerosis or systemic lupus erythematosus (SLE). The number of people recruited for the trial is around 600 at 15 to 20 sites across the US, who will be followed up for a period of 13 months.

Persons who had not responded to the vaccine or had a suboptimal response are eligible for participation in the trial. They also must be on mycophenolate mofetil or mycophenolic acid, methotrexate or B cell-depleting drugs for their condition.

Another objective of the trial is to evaluate the immune response with the extra dose after stopping the immunosuppressive therapy for autoimmune disease. Hence, participants who are taking mycophenolate mofetil/mycophenolic acid or methotrexate will be randomly assigned either to continue with their medication as before or stop taking the medication for a short time before and after receiving the extra vaccine dose.

(Source: NIH News release, August 27, 2021)