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Nor-vaC

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

Project Manager
PhD fellow


ABOUT THE PROJECT

The purpose of this project is to evaluate the immunological response to COVID-19 vaccines in people who are on immunosuppressive medication on the basis of chronic disease in the gastrointestinal system or joints. The Nor-vaC study wants to clarify whether the usual vaccination program against Covid-19 provides sufficient protection in people who use immunosuppressive drugs. It is also of great importance to find out how long the vaccine protects, and whether people who use immunosuppressive drugs need more vaccine doses after a while, in order to maintain good protection against the virus.

In Norway, at least 34,000 people live in this category. The purpose of vaccinating against COVID-19 is to teach the immune system to recognize this virus. If the immune system is suppressed by medication, this may mean that the response to the vaccine will be weak. We know from the past that some immunosuppressive medicines can reduce the effect of the flu vaccine, and thus reduce the protection of the vaccine. We do not know whether people using such medication have weaker or shorter protection against COVID-19 after vaccination than the normal population has. We also do not know whether certain types of immunosuppressive medication weaken the vaccine response more than other types of immunosuppressive medication can. However, it is of great importance to survey whether vaccines against SARS-CoV2 produce a strong and lasting immune response. If the immune response after vaccination is weakened in those who use immunosuppressive drugs, this may mean that this group of people needs more vaccine doses. It may also mean that the important, immunosuppressive medication they are on must be adjusted, so that the vaccine can have a better effect.

The Nor-vaC study is a collaborative project between Diakonhjemmet Hospital, the 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 who use immunosuppressive drugs.

The research project is expected to be of great importance to people with rheumatic diseases and diseases of the intestines and liver. The results will be able to form the basis for vaccine recommendations and treatment recommendations for this patient group during the current COVID-19 pandemic. The study may also have consequences for treatment advice and advice on vaccines beyond the current pandemic. The research question about the strength and duration of COVID vaccine protection is of great interest to the patient group also globally, because we currently have very little knowledge.

WHO CAN JOIN?

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

Recruitment of participants in the study has been completed.

WHAT DOES THE STUDY INCLUDE?

The participants in the study take a blood sample before the first vaccine dose is given. A new blood sample must then be taken 2-4 weeks after the next vaccine doses against Covid-19. Some of the participants take extended blood tests for a particularly thorough survey of how well the immune system has reacted to the vaccine. Those who participate in the research project receive answers to their vaccine tests (antibodies) at helsenorge.no. The study plans to take regular blood samples from the participants, so that you can see how long the antibodies against COVID last. We will also register personal information such as gender, age, disease diagnosis and current medication. The study plans to monitor the vaccine response of the participants for up to 5 years.

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

‍Useful information for you who participate in the Nor-vaC study at Diakonhjemmet Sykehus:‍

  • A few patients take extended tests, they receive their own tailored information directly by email or phone.
  • Blood samples to look at the antibody response after vaccination are taken 2 - 4 weeks after the second vaccine dose. If holiday or other conditions make it difficult to take a sample within 4 weeks, we allow sampling up to 8 weeks after vaccination, but this is less desirable.
  • Thereafter, samples are taken every 3 months. You will receive an SMS reminder when the time for a new blood test is approaching.
  • There is drop-in blood sampling in the evening at 16 - 20 every weekday.

NB: ONLY study tests are taken in the evening, not ordinary control/follow-up tests of your rheumatic disease.

  • If, in any case, you are going to take blood tests with us as part of regular follow-up, you can come as before during the day between 8am and 3pm, go to the polyclinic desk and ask for an envelope for study blood samples at the same time as the routine tests ordered by the rheumatologist. Due to capacity reasons, there is no opportunity to come only for study tests during the day.