Study Seeks Autoimmune Disease Patients to Test COVID-19 Vaccines
Conducted by the University of Pittsburgh Medical Center (UPMC), the CoVER study is investigating if patients with autoimmune diseases respond similarly to the vaccine, by measuring the levels of antibodies against the SARS-CoV-2 — the virus that causes COVID-19 — and whether the vaccination may lead to “flare-ups” or worsening of symptoms.
The clinical trials that supported the approval of the COVID-19 vaccines lacked patients with underlying autoimmune diseases. Thus, the impact of the vaccination in these patients remains unknown.
“There is little information regarding the COVID-19 vaccine’s effectiveness and overall safety for patients with autoimmune diseases,” Robyn Domsic, MD, a rheumatologist at UPMC and the study’s co-lead investigator, said in a press release.
“We want to understand whether these patients produce the same level of neutralizing antibodies, whether there is a difference in vaccine tolerability or side effects and whether the vaccines can cause flare ups in these patients’ conditions,” she added.
Besides Sjogren’s syndrome, the study is open to adults (18 or older) with rheumatoid arthritis, scleroderma, and idiopathic inflammatory myopathy, who were diagnosed by a rheumatologist. Patients must be willing to receive, or have received, a COVID-19 vaccine or booster.
The study will last 12 months and involves nine visits over four months. Four of these visits will take place at the Falk Medical Building, UPMC, in Pittsburgh, and the remaining five will be conducted by phone.
Participants will be required to provide three to four blood samples throughout the study. Also, they’ll need to answer online questionnaires about their medication use and potential changes in their symptoms.
Adults willing to enroll in the CoVER study, or seeking further information, can do so by sending an email to [email protected]
Recent research suggests that the majority of people with Sjögren’s and other rheumatic diseases are capable of generating antiviral antibodies after their first COVID-19 vaccine shot. However, their standard treatment regimen may affect their ability to develop antibodies.
The study, conducted in patients who received the Moderna and Pfizer-BioNTech vaccines, showed that the load of antiviral antibodies was markedly lower in patients receiving mycophenolate or rituximab, and appears to be higher among those receiving anti-tumor necrosis factor inhibitors.