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COVID-19 Vaccine Study in Autoimmune Immunocompromised Patients

If you have an inflammatory or autoimmune condition — such as rheumatoid arthritis, lupus, Crohn’s disease, or psoriasis — and take disease-modifying or immunosuppressant medication to treat it, it’s natural to have questions about getting a COVID-19 vaccine.

We encourage you to check out our main guide: Getting a COVID-19 Vaccine: What to Know If You’re Immunocompromised for a basic overview of the COVID-19 vaccine landscape for people with inflammatory and autoimmune health conditions. You can also read these other resources on COVID-19 vaccines for people who are immunocompromised:

You may have heard, for example, that people on immunosuppressant and immunomodulating medications — such as methotrexate and biologics — were not included in the phase 3 clinical trials that led to the emergency use authorization for the Pfizer and Moderna COVID-19 vaccines.

While this is true, it doesn’t mean you shouldn’t get vaccinated when you have the chance.

It is common to not include people who are on medications that can affect the immune system, including oral corticosteroids, disease-modifying antirheumatic drugs (DMARDs), biologics, and cancer treatment (chemotherapy, radiation, immunotherapy) in vaccine clinical trials.

This is because these vaccines may work less effectively (be less protective). The trials need to first understand how the vaccines work in healthy adults before they can be studied in other patient populations.

That said, we have been fielding many questions from the autoimmune patient community asking: When will we have data on immunocompromised patients who get the vaccine?

The answer: sooner than you might think.

Several research groups across the U.S. and around the world are designing and planning studies to address these types of questions:

  • Does the COVID-19 vaccine work as well in autoimmune patients or people on immunosuppressant medication as the general population?
  • Do certain immunosuppressant medications affect COVID-19 vaccine effectiveness differently than others?
  • Are COVID-19 vaccine side effects or adverse events different in autoimmune patients or people on immunosuppressant medication?

We spoke with Alfred Kim, MD, PhD, Assistant Professor of Medicine, Pathology, and Immunology at Washington University in St. Louis, Missouri, to share more about the COVID-19 vaccine study he is overseeing. Dr. Kim is also the Codirector of the Washington University Lupus Clinic.

This study is currently open only to people who are patients or employees of Washington University and its affiliated hospitals, so this is not an invitation to participate. Once the vaccine is more widely available, patients who see providers at Washington University will also be eligible to participate.

Since multiple medical centers are planning studies similar to the one at Washington University, you can ask your health care provider if they are aware of any research on autoimmune or immunocompromised patients being done locally. Dr. Kim says that partnerships are just beginning to form, in addition to those listed above.

We want to make sure that the general patient community is aware of research that is underway to help shed light on how immunocompromised and autoimmune patients fare after getting a COVID-19 vaccine.

However, public health experts don’t want you to think that you necessarily need to wait for this kind of study data before getting vaccinated.

Because the COVID-19 vaccines from Pfizer and Moderna (as well as those in clinical trials from AstraZeneca and Johnson & Johnson/Janssen) are not live vaccines, doctors are not as worried about safety/side effect issues in autoimmune and immunocompromised patients. The bigger concern is that these vaccines may be less protective against the coronavirus in autoimmune and immunocompromised patients. If you have concerns about getting the COVID-19 vaccine when it becomes available to you, talk to your doctor about your personal situation and make a decision together.

COVID-19 Vaccine Responses in Patients with Autoimmune Disease: The COVaRiPAD Study

This study — being conducted at Washington University and with its affiliated hospitals in the St. Louis area — is focusing on patients with rheumatic disease, inflammatory bowel disease, uveitis, autoimmune dermatologic conditions, and multiple sclerosis. Participants choose on their own to get a COVID-19 vaccine based on availability and their eligibility under the emergency use authorization (e.g., right now it is only available to health care workers and people who live and work in long-term care facilities).

The main objectives of the study are:

  • To determine the quantity and quality of the antibody response to the COVID-19 vaccine in people who have autoimmune diseases and who may be on immunosuppressive medication (meaning, does the vaccine help these patients make enough high-quality antibodies — parts of the immune system that recognize germs and foreign invaders — to get rid of the coronavirus before it infects or hurts you?)
  • To characterize the adverse events (side effects) in people with autoimmune conditions (meaning, does the vaccine cause different/worse side effects in these patients compared with the general population?)

The researchers will be looking to compare the results of the people in this study with a comparison group of people without autoimmune disease and who are not on immunosuppressant medications healthy patients.

They are also interested in patient-reported outcomes (PROs) — which are surveys that measure patients’ self-reports of their symptoms, disease activity, and aspects of overall health — after receiving the vaccine. This patient-reported data may lead to future areas of study. For instance, one area of interest for Dr. Kim is whether sleep quality has any impact on vaccine effectiveness. “Past research has shown that people who get worse sleep the night before getting certain vaccines have a weaker response,” Dr. Kim says, noting that many rheumatic conditions are notorious for having high levels of sleep disturbance.

In addition to measuring the levels and quality of antibodies, the researchers will also be looking at other aspects of the immune system, such as the B cell response. B cells are a part of the immune system that help to create antibodies in response to germs and invaders. A portion of these B cells have an extended lifespan — termed memory B cells — that are important in having an effective vaccine response, especially over time.

“There’s a theoretical risk that disease-modifying drugs could alter the quality of the B cell response to the vaccine, so we want to study this,” says Dr. Kim. “Overall, we are looking to understand whether the medicines we use to treat autoimmune and inflammatory conditions change how well immune cells respond to the vaccine.”

How the Study Works

Participants in the study will go through a series of blood tests at different points before and after they get their two doses of the vaccine. Researchers will study these blood samples for quality and quantity of antibodies, B cells, and more. Participants will get tested:

  • Before getting the COVID-19 vaccine for a baseline measure
  • Up to two days before getting the second (booster) dose of the COVID-19 vaccine
  • One week after receiving the second (booster) dose (“this is when the peak immune response to vaccination is observed,” says Dr. Kim)
  • Monthly for the next three months
  • Six months after getting the vaccine

Reporting Results

Dr. Kim estimates that within a month or so of the study commencing, they should have some preliminary data about responses to the vaccine in terms of antibody levels and side effects. How generalizable the results will be to the greater autoimmune community, however, remains to be seen.

The researchers are not yet sure how many people they will need with each condition and on each type of medication to be able to draw conclusions about how the vaccine works in each type of patient.

Of course, it’s hard to predict how many people will enroll and what the data will be like, but Dr. Kim says the initial response within the Washington University community has been overwhelmingly supportive. There have already been many referrals of people who hope to participate. As well, there may be the opportunity for collaboration and data sharing with other research teams, which could help generate data more quickly — and, in turn, answer more of the questions that doctors and patients have about COVID-19 vaccines in the autoimmune patient community.

“We want people to be able to make confident, informed decisions about the COVID-19 vaccine in autoimmune patients using high-quality information from research,” says Dr. Kim.

CreakyJoints and the Global Healthy Living Foundation will be following this and other research closely and will share more information as we have it.

Join our free COVID-19 Patient Support Program to stay informed.

COVID-19 Vaccination Considerations for Persons with Underlying Medical Conditions. COVID-19. U.S. Centers for Disease Control and Prevention. December 26, 2020. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/underlying-conditions.html.

Different COVID-19 Vaccines. Coronavirus Disease 2019 (COVID-19). U.S. Centers for Disease Control and Prevention. November 24, 2020.https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html.

HSS Statement on COVID-19 Coronavirus Vaccinations for People with Rheumatic Diseases. Hospital for Special Surgery. December 19, 2020. https://www.hss.edu/conditions_hss-statement-covid-19-coronavirus-vaccinations-rheumatic-diseases.asp.

Interview with Alfred Kim, MD, PhD. Assistant Professor of Medicine, Pathology, and Immunology at Washington University in St. Louis, Missouri

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