In general, vaccine responses are variably reduced in a large group of patients with auto-immune diseases (AID), mostly depending on the type and dose of the used immunosuppressive treatment(s).
Currently, there is the pressing question whether vaccination against SARS-CoV-2 is less effective in these patients with immunosuppression (ISP). The main objective of this vaccination study is to elucidate whether the efficacy of SARS-CoV-2-targeted vaccination is reduced in ISP compared to patients with AID without immunosuppressive drugs or healthy individuals, and whether the persistence of SARS-CoV-2-specific immunity differs over time because of ISP. To get much better informed and prepared regarding current vaccination strategies, we will use the unique platform of our T2B consortium, a well-established close collaboration and infrastructure of 6 different academic hospitals, Reade, RIVM and Sanquin Blood Supply Foundation.
Building on several clinical studies already initiated at the start of the SARS-CoV-2 pandemic by our clinical T2B partners, we will perform in-depth analysis of the humoral and cellular vaccine-induced immunity against SARS-CoV-2. In one of our previous prospective observational studies we focus on the longevity of the immune response in ISP after primoinfection and the role of this previous infection in the early vaccine response.
In the current vaccination study in AID, we will collect longitudinal clinical data and samples from selected 3000 patients treated with frequently prescribed immunosuppressive drugs representing distinct categories within the wide spectrum of immunosuppression to determine vaccination efficacy in ISP. Humoral response in ISP upon vaccination will be compared to the humoral response in 1000 patients diagnosed with similar AID but without immunosuppression as well as to the response in healthy controls. In addition, we will determine the safety of vaccination and changes in disease activity of the underlying AID after vaccination (disease flaring), by comparing to a separate control group of 1000 patients with similar AID that are nót willing to be vaccinated. Together with our previous objectives, this will provide vital insights into the determinants, quality and longevity of the immune response in ISP patients that can be used to optimize vaccination regimens, providing guidance on the necessity and timing of additional booster vaccines and/or rational advice on restrictive measures to prevent SARS-CoV-2 (re)infection.