Researchers to Study Extra Covid-19 Shot in Autoimmune Patients

Patients with lupus, multiple sclerosis, and other autoimmune diseases who haven’t responded well to Covid-19 vaccines can expect to have answers by November on how a third dose might affect them.

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, unveiled a clinical trial Friday to study the antibody response of patients with autoimmune disease who received an extra dose of an authorized or approved Covid-19 vaccine.

The announcement comes two weeks after the Centers for Disease Control and Prevention and the Food and Drug Administration made third doses available for patients with weaker immune systems, which includes cancer patients. Many of the medications to treat autoimmune disease also suppress the immune system, but it’s not clear yet whether the lack of antibody response is due to the drugs or the disease itself.

“The study is important because we have a subset of individuals who are not making an effective response to the vaccine,” Judith James, a rheumatologist and one of the co-leaders of the trial, said in an interview. “This study is looking for a way that we could potentially help boost their response or to maximize their response by giving them a third vaccination.”

The clinical trial will measure whether the extra shot is effective. If it’s not, then the researchers and clinicians will adapt their approach in the future to see if they can find other ways to help improve their protection against Covid-19, said James, who is the vice president of clinical affairs and program chair of the arthritis and clinical immunology research program at the Oklahoma Medical Research Foundation.

“We need the data to see if this is going to actually be effective. Right now, we’re just telling everybody, ‘Oh, go get a third shot.’ And we don’t know whether or not that’s actually helping everyone, or if it’s only helping a subset of people,” she said.

J&J Second Dose

The clinical trial also offers an avenue for a second shot of Johnson & Johnson’s vaccine. Due to insufficient data, the federal recommendation for an additional dose only applies to Pfizer Inc. and Moderna Inc.'s vaccines—meaning that anyone who’s immunocompromised but got J&J can’t get an extra dose under the federal guidelines.

But the clinical trial is studying all three vaccines that are available in the U.S., and everyone in the study will get an additional dose of whatever vaccine they got the first time around.

“This is the way to get an extra vaccine,” of J&J, James said, “and for us to see how much that actually increases the immune responses that our patients have.”

The trial will enroll 600 adult volunteers in 15 to 20 locations across the U.S. who have one of five autoimmune diseases: multiple sclerosis, pemphigus—a group of disorders that causes blisters around the skin or mucous membranes—rheumatoid arthritis, the most common form of lupus, or systemic sclerosis.

Everyone in the study must have responded poorly to their initial vaccination and be on one of three therapies that are known to suppress the immune system: mycophenolate mofetil or mycophenolic acid; methotrexate; or B-cell depleting drugs.

After receiving an additional Covid-19 vaccine dose, volunteers will either continue taking the therapy for their autoimmune disease or will pause their medication before and after getting their extra shot. The study will look at the proportion of participants who have a significantly better antibody response four weeks after the extra shot.

Some physicians are already holding off on medications for the underlying autoimmune disease around the time of the additional dose, but “we don’t really have data to know if that’s helpful,” James said. As part of clinical trial participation, “we are carefully monitoring those patients to make sure that they don’t have reactivation or worsening of their underlying autoimmune disease when they’re off those medicines.”

Even if study volunteers don’t produce antibodies, researcher will be looking at whether they have certain cells that are providing protection against Covid-19. A study published in May found that a patient with low antibody response to the virus that causes Covid-19 still had robust immunity from T-cells, white blood cells that protect the body from infection.

The NIH expects preliminary results in November but researchers will follow patients for 13 months.