PROJECT

Nor-vaC

Immunological response to COVID-19 vaccine in patients on immunosuppressive therapy

project manager

postdok

About the project

The aim of this project is to evaluate the immunologic response to COVID-19 vaccines in people on immunosuppressive medication due to chronic gastrointestinal or joint disease. The Nor-vaC study aims to clarify whether the standard vaccination program against COVID-19 provides adequate protection in people taking immunosuppressive drugs. It is also of great importance to know how long the vaccine protects, and whether people taking immunosuppressants need more vaccine doses after a while to maintain good protection against the virus.

In Norway, there are at least 34,000 people living in this category. The purpose of giving vaccines against COVID-19 is to teach the immune system to recognize this virus. If the immune system is suppressed by medication, it may mean that the response to the vaccine is weak. We know from previous experience that some immunosuppressive drugs can reduce the effectiveness of the flu vaccine, and therefore reduce the protection of the vaccine. We do not know whether people who use such medication have weaker or shorter protection against COVID-19 after vaccination than the general population. We also do not know whether certain types of immunosuppressant medication impair the vaccine response more than other types of immunosuppressant medication may do. However, it is of great importance to establish whether vaccines against SARS-CoV2 produce a strong and durable immune response. If the immune response after vaccination is weakened in those taking immunosuppressants, it may mean that this group of people need more vaccine doses. It may also mean that the important immunosuppressant medication they are on needs to be adjusted so that the vaccine can be more effective.

The Nor-vaC study is a collaborative project between Diakonhjemmet Hospital, the Norwegian Institute of Public Health (FHI), the Department of Immunology at Oslo University Hospital (OUS) and Akershus University Hospital (AHUS). The results of the study will help FHI to design the best possible vaccine advice for people using immunosuppressive drugs.  

The research project is expected to have a major impact on people with rheumatic diseases and diseases of the gut and liver. The results could inform vaccine recommendations and treatment recommendations for this group of patients during the current COVID-19 pandemic. The study may also have implications for treatment and vaccine advice beyond the current pandemic. The research question on the strength and duration of COVID vaccine protection is of great interest for the patient group also globally, because we currently have very little knowledge.

Who can participate?

Patients from the Department of Rheumatology at Diakonhjemmet Hospital and the Department of Gastroenterology at AHUS on immunosuppressive treatment have been asked to participate.

Recruitment of study participants has been completed.

Project arrangement

Participants in the study have a blood test before the first vaccine dose is given. A second blood test is then required 2-4 weeks after the next Covid-19 vaccine doses. Some participants will have extended blood tests for a more in-depth assessment of how well their immune system has responded to the vaccine. Those participating in the research project will receive the results of their vaccine tests (antibodies) on helsenorge.no. The study plans to take regular blood samples from participants to see how long the antibodies against COVID last. We will also record personal data such as gender, age, disease diagnosis and current medication. The study plans to monitor the vaccine response of participants for up to 5 years.

The vaccine is administered locally in the district/municipality where the patient lives.

Usefulinformation for those participating in the Nor-vaC study at Diakonhjemmet Hospital:‍

  • A few patients take extended tests, they receive their own personalized information directly by email or phone.
  • Blood samples to look at the antibody response to the vaccine are taken 2-4 weeks after the second vaccine dose. If vacation or other circumstances make it difficult to sample within 4 weeks, we allow sampling up to 8 weeks post-vaccine, but this is less desirable.
  • Thereafter, samples are taken every 3 months. You will receive a reminder by text message when the next blood test is due.
  • There are drop-in blood tests in the evening from 16:00 to 20:00 every weekday.

NB: During evening hours, ONLY study tests are taken, not regular control/follow-up tests of your rheumatic disease.

  • If you still need to take blood tests as part of your regular follow-up, you can come as before during the daytime from 8 am to 3 pm, go to the outpatient clinic desk and ask for an envelope for study blood tests at the same time as the routine tests ordered by the rheumatologist. For capacity reasons, it is not possible to come for study tests only during the day.

Partners

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