Vaccine Immunogenicity and Safety in ImmunoDeficient Patients [VISID, study data contributed to the CITF Databank]

They also aimed to estimate the frequency of adverse events after COVID-19 vaccination and measure the frequency of COVID-19 infections in vaccinated immunodeficient patients.

Methods

This cohort study recruited individuals with an inborn error of immunity (predominant antibody deficiency, combined B-cell and T-cell immunodeficiency, defect of intrinsic and innate immunity, or other) in addition to a control group of immunocompetent participants. Participants were then divided into vaccine naive and vaccine experienced subgroups. Vaccine naive participants were followed up at their first vaccination; both vaccine naive and vaccine experienced participants were followed up at their second, third and, for the immunocompromised patient cohort only, the fourth vaccinations.

Furthermore, follow-up visits after vaccinations were done at 4 weeks and 24 weeks after the second, third and fourth vaccinations, and at 48 weeks after second or third dose only when the third or fourth (for patient cohort) vaccinations were not received, respectively. At each visit, participants completed a questionnaire and provided a blood sample. Contributed dataset contents: The datasets include 71 participants who provided baseline demographic information between March 2021 and September 2022.

All participants gave one or more blood samples between March 2021 and November 2022. A total of 170 blood samples were collected. Variables include data in the following areas of information: demographics (age, sex, ethnicity), general health (BMI, chronic conditions, treatments), SARS-CoV-2 vaccination, longitudinal follow-up for COVID-19 infections, cell-mediated immunity (IFN-γ+ T cells), and serology (IgA, IgG, and IgM against SARS-CoV-2 RBD, nucleocapsid, and spike proteins).

[1]: Please contact original study team for vaccine safety data.