Just weeks before the lockdowns for the Covid-19 pandemic began in March 2020, Nicole Wilson received a disheartening diagnosis. She had been dealing with a sinus infection for months and, after seeing several specialists, learned that she had a disorder that had weakened her immune system and made her more vulnerable to infections.
The disease, Common Variable Immune Deficiency, or CVID, prevents one’s 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,” said Wilson, a talent manager from Pittsburgh and mother of a 5 year old girl. . “It was very overwhelming and really scary.”
The immune disorder puts Wilson at risk of serious illness from Covid-19. She immediately quarantined and still hasn’t seen any friends for over a year.
Millions of Americans suffer from immune disorders or autoimmune diseases – like lupus, rheumatoid arthritis, or Crohn’s disease – that require them to take immunosuppressive drugs for life. Because people with weakened immune systems have been largely excluded from Covid-19 vaccine trials in the United States and around the world, it is not known what protection they get from the 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.
This is 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 drugs. Researchers at the National Institutes of Health are currently recruiting participants across the country to be tested before and after receiving their Covid-19 vaccine.
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 and four weeks after vaccination and compared with blood test results from people who do not have immune system disorders and others who do. Preliminary results of her immunity will be available in a few months, but she will return for blood checks every 6, 12 and 24 months.
“This study is so important to people like me who are undergoing cancer treatment or taking immunosuppressive drugs, because we need to know if these vaccines are working,” Wilson said. “I am so excited to be a part of this science and to be a part of the future.”
Even as more than 115 million Americans are now fully immunized against the coronavirus, people with weakened immune systems and organ transplant recipients are wondering what it is safe to do.
“We understand how frustrating it is,” said Emily Ricotta, an NIH researcher and principal investigator of the study. “This year has been long and difficult for everyone and having to continue this vigilance is tiring.”
Ricotta and her team saw immense interest in the study and received over 500 emails from patients willing to participate. She hopes to extend the study to children between the ages of 12 and 15 since the Food and Drug Administration cleared the Pfizer vaccine for them.
The aim of the study is to help immunocompromised patients understand their level of protection after vaccination.
“There are people who cannot get the vaccine for some reason, or if they do, they don’t produce a response,” she said. “This is why it is really important for everyone else who can get the vaccine and who should be producing a response to get the vaccine.”
Early data suggests that people who take drugs that suppress their immune systems have a significantly lower response to the vaccine than healthy people. The data showed a decrease in the antibody response to the vaccine in people with blood cancers as well as in people on drug treatment 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 number of transplant patients did not achieve a reasonable response to the two doses of the vaccine,” said Dr Dorry Segev, study author and associate vice president of research and professor. of Surgery at Johns Hopkins University.
Segev’s patients in the study have been frustrated as public health restrictions loosen for fully vaccinated patients, amid fear of venturing out.
One of her trial participants, Laura Burns, 71, had received 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, his body did not mount detectable antibodies against the virus.
“I was devastated,” Burns said. “It was so difficult, because I couldn’t wait to get back to my normal life form.”
Burns looks forward to the day she can safely visit her stepdaughter, but waits until she finds out more about her protective status.
The complexity of the immune system makes it difficult to predict why some immunocompromised patients respond positively to the vaccine and others do not. Segev, however, is optimistic because the number of participants who developed antibodies after two doses of the vaccine was significantly higher than those who developed antibodies after one dose. He said a three-dose vaccination schedule could serve as a booster for immunocompromised patients, although no clinical trials are yet underway.
Johns Hopkins trial participant Valen Keefer, 38, received two organ transplants and, despite being on immunosuppressive therapy, was able to build an immune response with the Moderna vaccine.
She is “cautiously optimistic” although she still does not know how much protection she has against the virus.
Wilson, who now goes to the hospital once a month for infusions to boost his immune system, is trying to be positive about returning to a normal life.
“If I had to 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’m capable of doing today, and it has helped me cope with everything.”