'We need to know': Covid vaccine trial launched for people with immune disorders

Just weeks before the Covid-19 pandemic began in March 2020, Nicole Wilson received a disheartening diagnosis. She had dealt with a sinus infection for months and after seeing several specialists she learned that she had a disorder that had weakened her immune system and made her more prone to infections.

The disease, the common variable immunodeficiency syndrome, or CVID, prevents your body from making enough antibodies to fight off viral or bacterial infections.

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

The immune disease put Wilson at risk for serious Covid-19 disease. She immediately quarantined herself and has not seen any friends for over a year.

Millions of Americans have immune or autoimmune diseases like lupus, rheumatoid arthritis, or Crohn’s disease that require lifelong immunosuppressive treatments. Since people with compromised immune systems have been largely banned from Covid-19 vaccine trials in the US and around the world, it is not known how much protection they will receive from vaccinations. One recently 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.

For this reason, Wilson was excited to be one of the first participants in a clinical study examining the immune response to the Covid-19 vaccination in people with various immune disorders or taking immunosuppressive drugs. Researcher at the National Health Institute are currently Recruiting participants be tested across the country before and after the Covid-19 vaccination.

Nicole Wilson is part of a National Institutes of Health clinical study looking at how people with compromised immune systems react to the Covid-19 vaccination.Courtesy Nicole Wilson

Wilson received the second dose of the Pfizer vaccine in early May. Your body’s antibody and T-cell responses are tested three to four weeks after vaccination and compared to blood test results from people with no immune system disorders and others who do. Preliminary results on her immunity will be in a few months, although she will have blood tests again after 6, 12, and 24 months.

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

Although more than 115 million Americans are now fully vaccinated against the coronavirus, people with compromised immune systems and organ transplant recipients wonder what is safe for them.

“We understand how frustrating it is,” said Emily Ricotta, a research fellow at the NIH and lead investigator on the study. “It’s been a long, tough year for everyone and it is exhausting to keep this vigilant.”

Ricotta and her team saw great interest in the study and received over 500 emails from patients willing to participate. She hopes to expand the study to children between the ages of 12 and 15 as the Food and Drug Administration has approved the Pfizer vaccine for them.

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

“There are some people who for some reason can’t be vaccinated or when they do they don’t produce a response,” she said. “So it’s really important for everyone else who can get a shot and should respond to the vaccination.”

Early data suggests that people who take drugs that suppress their immune systems have a significantly weaker response to the vaccine than healthy people. Data have shown a decreased antibody response to the vaccine in those with blood cancer as well as the Medicines for inflammatory diseases.

By doing Organ transplant studyResearchers at Johns Hopkins University found that patients who take a certain class of drugs called antimetabolites are less likely to develop an immune response.

“I am quite disappointed that a significant number of transplant patients have not received an adequate response from either dose of vaccine,” said Dr. Dorry Segev, study author and vice chairman of research and professor of surgery at Johns Hopkins University.

Segev’s patients on the study have been frustrated as public health restrictions on fully vaccinated patients relax as they worry about leaving.

One of his study participants, Laura Burns, 71, had a double lung transplant in 2016 and was taking immunosuppressive drugs to prevent her body from rejecting the new lungs. Despite two doses of the Moderna vaccine, her body did not build any detectable antibodies to the virus.

“I was devastated,” said Burns. “It was so hard because I was really looking forward to living a normal life again.”

Burns has been waiting eagerly for the day she can safely visit her stepdaughter, but is holding back until she learns more about her protected status.

Laura Burns has been on immunosuppressive medication since a double lung transplant in 2016.Nimai Malle

The complexity of the immune system makes it difficult to predict why some immunocompromised patients will respond positively to the vaccine and others will not. Segev is hopeful, however, as 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 vaccination schedule could serve as a booster dose for immunocompromised patients, although clinical trials are not ongoing.

38-year-old Johns Hopkins study participant Valen Keefer received two organ transplants and successfully triggered an immune response with the Moderna vaccine despite immunosuppressive therapy.

Valen Keefer is receiving immunosuppressive therapy after two organ transplants. After two doses of the Moderna vaccine, tests showed she had an immune response to the virus.Courtesy Valen Keefer

She is “cautiously optimistic” although she still isn’t sure how much protection she has from the virus.

Wilson, who now visits a hospital once a month for IV fluids to boost her immune system, tries to positively assess the return to normal life.

“When I think about what’s going to happen this summer or this fall, it can get very overwhelming,” she said. “I spend a lot of time thinking about what I can do today and that has helped me deal with everything.”

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