SARS-CoV-2-specific immune responses in elderly and immunosuppressed participants and patients with hematologic disease or checkpoint inhibition in solid tumors: study protocol of the prospective, observational CoCo immune study

• Main Authors: Behrens, G.M.N (Author), Cossmann, A. (Author), Dopfer-Jablonka, A. (Author), Falk, C.S (Author), Hasenkamp, J. (Author), Heesen, G. (Author), Heinemann, S. (Author), Hummers, E. (Author), Kallusky, J. (Author), Klawonn, F. (Author), Mikuteit, M. (Author), Müller, F. (Author), Niewolik, J. (Author), Overbeck, T.R (Author), Roder, S. (Author), Schröder, D. (Author), Stankov, M.V (Author), Steffens, S. (Author), Vahldiek, K. (Author)
• Format: Article
• Language: English
• Published: BioMed Central Ltd 2022
• Subjects: Checkpoint inhibition; Coronavirus; COVID-19; Elderly; Hematology; Humoral and cellular immunity; Immunocompromised people; Immunogenicity; Pandemic; SARS-CoV-2; Serological testing; Social participation; Solid tumor
• Online Access: View Fulltext in Publisher

 Background: Immunocompromised people (ICP) and elderly individuals (older than 80 years) are at increased risk for severe coronavirus infections. To protect against serious infection with SARS-CoV-2, ICP are taking precautions that may include a reduction of social contacts and participation in activities which they normally enjoy. Furthermore, for these people, there is an uncertainty regarding the effectiveness of the vaccination. The COVID-19 Contact (CoCo) Immune study strives to characterize the immune response to COVID-19 vaccination in immunocompromised, elderly people, and patients with hematological or oncological diseases. The study uses blood-based screenings to monitor the humoral and cellular immune response in these groups after vaccination. Questionnaires and qualitative interviews are used to describe the level of social participation. Methods: The CoCo Immune Study is a mixed methods prospective, longitudinal, observational study at two large university hospitals in Northern Germany. Starting in March 2021, it monitors anti-SARS-CoV-2 immune responses and collects information on social participation in more than 600 participants, at least 18 years old. Inclusion criteria and subcohorts: Participants with (1) regularly intake of immunosuppressive medication (ICP-cohort) or (2) age ≥ 80 years (80 + -cohort). Additionally, patients with current or former (3) myeloid, (4) lymphatic disease or (5) solid tumor under checkpoint inhibition (3–5: HO-cohort). Exclusion criteria: (1) refusal to give informed consent, (2) contraindication to blood testing, (3) inability to declare consent. Participants complete a questionnaire at four different time points: prior to full vaccination, and 1, 6 and 12 months after completed vaccination. In addition, participants draw blood samples themselves or through a local health care provider and send them with their questionnaires per post at the respective time points after vaccination. Patients of the HO cohort dispense additional blood samples at week 3 to 12 and at month 6 to 9 after 2nd vaccination to gain additional knowledge in B and T cell responses. Selected participants are invited to qualitative interviews about social participation. Discussion: This observational study is designed to gain insight into the immune response of people with weakened immune systems and to find out how social participation is affected after COVID-19 vaccination. Trial registration: This study was registered with German Clinical Trial Registry (registration number: DRKS00023972) on 30th December 2020. © 2022, The Author(s).