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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.
Dopfer-Jablonka, Alexandra; Steffens, Sandra; Müller, Frank; Mikuteit, Marie; Niewolik, Jacqueline; Cossmann, Anne; Stankov, Metodi V; Behrens, Georg M N; Hummers, Eva; Heesen, Gloria; Schröder, Dominik; Roder, Sascha; Klawonn, Frank; Vahldiek, Kai; Hasenkamp, Justin; Kallusky, Jonathan; Falk, Christine S; Overbeck, Tobias R; Heinemann, Stephanie.
  • Dopfer-Jablonka A; Department for Rheumatology and Immunology, Hannover Medical School, Hannover, Germany.
  • Steffens S; German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Hannover, Germany.
  • Müller F; Department for Rheumatology and Immunology, Hannover Medical School, Hannover, Germany.
  • Mikuteit M; Department of General Practice, University Medical Center Göttingen, Humboldtallee 38, 37073, Göttingen, Germany.
  • Niewolik J; Department for Rheumatology and Immunology, Hannover Medical School, Hannover, Germany.
  • Cossmann A; Department for Rheumatology and Immunology, Hannover Medical School, Hannover, Germany.
  • Stankov MV; Department for Rheumatology and Immunology, Hannover Medical School, Hannover, Germany.
  • Behrens GMN; Department for Rheumatology and Immunology, Hannover Medical School, Hannover, Germany.
  • Hummers E; Department for Rheumatology and Immunology, Hannover Medical School, Hannover, Germany.
  • Heesen G; German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Hannover, Germany.
  • Schröder D; CiiM-Centre for Individualised Infection Medicine, Hannover, Germany.
  • Roder S; Department of General Practice, University Medical Center Göttingen, Humboldtallee 38, 37073, Göttingen, Germany.
  • Klawonn F; Department of General Practice, University Medical Center Göttingen, Humboldtallee 38, 37073, Göttingen, Germany.
  • Vahldiek K; Department of General Practice, University Medical Center Göttingen, Humboldtallee 38, 37073, Göttingen, Germany. dominik.schroeder@med.uni-goettingen.de.
  • Hasenkamp J; Department of General Practice, University Medical Center Göttingen, Humboldtallee 38, 37073, Göttingen, Germany.
  • Kallusky J; German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Hannover, Germany.
  • Falk CS; Department of Computer Science, Ostfalia University of Applied Sciences, Wolfenbuettel, Germany.
  • Overbeck TR; Department of Computer Science, Ostfalia University of Applied Sciences, Wolfenbuettel, Germany.
  • Heinemann S; Clinic for Hematology and Medical Oncology, University Medical Center Göttingen, Göttingen, Germany.
BMC Infect Dis ; 22(1): 403, 2022 Apr 25.
Article in English | MEDLINE | ID: covidwho-1808345
ABSTRACT

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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / Hematologic Diseases / Neoplasms Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Aged / Humans Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: S12879-022-07347-w

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / Hematologic Diseases / Neoplasms Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Aged / Humans Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: S12879-022-07347-w