– This is very important for the patients. This study will give us more knowledge about how the vaccine works in immunocompromised individuals. We will find out whether they achieve adequate protection of the vaccine, or whether they must continue with other measures such as isolation and focus on their close contacts. The support from CEPI allows us to carry out this study on such a large scale, and with so many different patients, that we can quickly gain knowledge that may influence national vaccine advice. The knowledge will also be shared with the rest of the world, comments John Torgils Vaage.
He is Professor at the Institute of Clinical Medicine at the University of Oslo and Department head at the Division of Laboratory Medicine at Oslo University Hospital.
The Coalition for Epidemic Preparedness Innovations, CEPI, will provide 26 million NOK to the study. In addition, a consortium of leading Norwegian health institutions including the with Norwegian Institute of Public Health – NIPH, Oslo University Hospital, Akershus University Hospital, Diakonhjemmet Hospital and the Institute of Clinical Medicine at the University of Oslo will provide an additional 30 million NOK. The project will be led by Oslo University Hospital at the Division of Laboratory Medicine.
– When the SARS-CoV-2 virus arrived, our scientists joined forces with our diagnostic service staff to provide a streamlined pipeline to monitor antibody responses to coronaviruses. We have built a unique partnership with many clinical environments, across institutional borders and including a critical collaboration with the NIPH, the project leader says.
This is the first time that CEPI provides funding to Norwegian research institutions.
Better protection of immunocompromised individuals
The aim of the study is to assess the immune response to COVID-19 vaccination in patients who are immunosuppressed or who have received organ transplantation and are receiving immunosuppression medication. Estimates suggest that tens of millions of people worldwide have a form of immunodeficiency. This group has a high risk of becoming seriously ill from a COVID-19 infection.
– We find that many immunocompromised patients respond poorly to COVID-19 vaccines, says the researcher.
This means that immunocompromised individuals do not obtain the same protection from the vaccine as individuals with a healthy immune system. More knowledge about the effect of COVID-19 vaccination of immunocompromised individuals is therefore of primordial importance for better protection and care of this vulnerable population.
Important for the global effort to combat COVID-19
A COVID-19 infection can persist for a much longer period than in healthy individuals. This means that patients can shed infectious virus particles for longer periods than what is the case when an individual with a well-functioning immune system has COVID-19. The persistence of the infection also increases the risk of virus replication and mutation, which can lead to the emergence of novel virus variants.
Knowledge about the effect of COVID-19 vaccination in this group is therefore also of primordial importance for the global effort to combat the COVID-19 pandemic.
Will assess the immune responses in vaccinated patients
The researchers will compare the immune response after vaccination in immunocompromised individuals with the immune response in healthy participants.
Selected patients who have a low or no immune response after receiving two doses of the vaccine will be offered a third dose and closely monitored by the researchers.
– We will identify patients who may benefit from an additional dose of the vaccine. An important question is whether individuals without protecting antibodies will be protected by T cells, which are an important part of the immune system, the researcher explains.
The researchers will also investigate which immunosuppressive medications are associated with a low or no immune response following COVID-19 vaccination.
Lastly, the researchers will assess which clinical parameters are related to risk factors for the lack of effect of COVID-19 vaccination.
CEPI
The Coalition for Epidemic Preparedness Innovations, CEPI, was launched in 2017 and is a partnership of public, private and humanitarian organisations. CEPIs aim is to improve the global pandemic preparedness by stimulating, coordinating and financing the global development of vaccines.
The funding for this study forms part of CEPIs mission to provide 1.16 billion NOK to clinical studies to fill knowledge gaps and to improve access to COVID-19 vaccines worldwide.
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1.9. It was added that John Torgils Vaage is also Department head at Division of Laboratory Medicine at Oslo University Hospital.