Covid vaccine trial launched for people with immune disorders

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Only weeks before the Covid-19 pandemic lockdowns began in March 2020, Nicole Wilson got a disheartening diagnosis. She’d been coping with a sinus infection for months, and after seeing multiple specialists, she learned she had a disorder that had weakened her immune system and made her more susceptible to infections.

The condition, common variable immune deficiency, or CVID, prevents her body from making enough antibodies to fight off viral or bacterial infections.

“CVID is a huge, huge thing to deal with, but finding out you have it at the start of a pandemic was just a double whammy,” Wilson, a talent manager from Pittsburgh and mother of a 5-year-old girl, said. “It was very overwhelming and really scary.”

The immune disorder put Wilson at risk for severe Covid-19 disease. She immediately quarantined and still has not seen friends for over a year.

Millions of Americans have immune disorders or autoimmune diseases — such as lupus, rheumatoid arthritis or Crohn’s disease — that require them to take immune-suppressing treatments for life. Because people with compromised immune systems were largely excluded from the Covid-19 vaccine trials in the U.S. and globally, it’s unknown how much protection they get from vaccination. A recent study by researchers at Johns Hopkins University found that only half of organ transplant recipients developed antibodies after two doses of a Covid-19 vaccine.

That’s why Wilson enthusiastically became one of the first participants in a clinical trial examining the immune response to Covid-19 vaccination in people with different immune disorders or on immunosuppressive medications. Researchers at the National Institutes of Health are currently recruiting participants across the country to be tested before and after they receive their Covid-19 vaccinations.

Image: Nicole Wilson (Courtesy Nicole Wilson)

Image: Nicole Wilson (Courtesy Nicole Wilson)

Wilson received the second dose of the Pfizer vaccine in early May. Her body’s antibody and T cell responses will be tested between three to four weeks after vaccination and compared with blood test results from people who don’t have immune system disorders and others who do. Preliminary results about her immunity will be available in a few months, although she’ll go back for blood checks at the 6, 12 and 24 months marks.

“This study is so important for people like me who are going through cancer treatment or on immunosuppressive drugs because we need to know if these vaccines work,” Wilson said. “I’m so excited to be part of that science and part of the future.”

Even as more than 115 million Americans are now fully vaccinated against the coronavirus, people with weakened immune systems and organ transplant recipients are left wondering what’s safe for them to do.

“We understand how frustrating it is,” said Emily Ricotta, a research fellow at the NIH and lead investigator of the study. “This has been a long, hard year for everybody and to have to continue that vigilance is tiring.”

Ricotta and her team have seen tremendous interest in the study and have received over 500 emails from patients eager to participate. She is hoping to expand the study to children between the ages of 12 and 15 since the Food and Drug Administration has authorized the Pfizer vaccine for them.

The goal of the study is to help patients who are immunosuppressed understand their level of protection after vaccination.

“There are some people who cannot get vaccinated for whatever reason, or if they do, they don’t produce a response,” she said. “That’s why it’s really important for everybody else who can get a shot and who should produce a response to get vaccinated.”

Early data suggests that people who are taking medications that suppress their immune system have a significantly weaker response to the vaccine than healthy people. Data has shown a decreased antibody response to the vaccine in those with blood cancers as well as those on medication for inflammatory disorders.

In the organ transplant study, researchers at Johns Hopkins University found that patients taking a particular class of drugs, called anti-metabolites, were less likely to develop an immune response.

“I am quite disappointed that a significant amount of transplant patients did not get a reasonable response from both doses of the vaccine,” said Dr. Dorry Segev, an author of the the study and associate vice chair for research and professor of surgery at Johns Hopkins University.

Segev’s patients in the study have been frustrated as public health restrictions relax for fully vaccinated patients, while they worry about venturing out.

One of his trial participants, Laura Burns, 71, had received a double lung transplant in 2016 and has been taking immunosuppressive medications to prevent her body from rejecting the new lungs. Despite two doses of the Moderna vaccine, her body has not mounted any detectable antibodies to the virus.

“I was devastated,” Burns said. “It was so hard, as I had been really looking forward to resuming some form of a normal life.”

Burns has been anxiously awaiting the day she can safely visit her stepdaughter but is holding off until she knows more about her protection status.

Laura Burns. (Nimai Malle)

Laura Burns. (Nimai Malle)

The complexity of the immune system makes it difficult to predict why some immunosuppressed patients have a positive response to the vaccine and others don’t. Segev, however, is hopeful because the number of participants who developed antibodies after two vaccine doses was significantly higher than those who developed antibodies after one dose. He said a three-dose vaccine regimen could serve as a booster shot for immunocompromised patients, although no clinical trials are underway yet.

Johns Hopkins trial participant Valen Keefer, 38, has received two organ transplants and despite being on immunosuppressive therapy has successfully mounted an immune response with the Moderna vaccine.

Valen Keefer. (Courtesy of Valen Keefer)

Valen Keefer. (Courtesy of Valen Keefer)

She’s “cautiously optimistic” although still unsure how much protection she has from the virus.

Wilson, who now visits a hospital once a month for infusions to boost her immune system, is trying to be positive about returning to normal life.

“If I were to think about what’s going to happen this summer or this fall, it can become very overwhelming,” she said. “I spend a lot of my time thinking about what I’m able to do today, and that’s helped me cope with everything.”

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