tetano
Editor, Senior Moderator
BMC Infect Dis
. 2022 Apr 25;22(1):403.
doi: 10.1186/s12879-022-07347-w.
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
Alexandra Dopfer-Jablonka[SUP] #[/SUP][SUP] 1 2 [/SUP], Sandra Steffens[SUP] #[/SUP][SUP] 1 [/SUP], Frank Müller[SUP] #[/SUP][SUP] 3 [/SUP], Marie Mikuteit[SUP] 1 [/SUP], Jacqueline Niewolik[SUP] 1 [/SUP], Anne Cossmann[SUP] 1 [/SUP], Metodi V Stankov[SUP] 1 [/SUP], Georg M N Behrens[SUP] 1 2 4 [/SUP], Eva Hummers[SUP] 3 [/SUP], Gloria Heesen[SUP] 3 [/SUP], Dominik Schröder[SUP] 5 [/SUP], Sascha Roder[SUP] 3 [/SUP], Frank Klawonn[SUP] 2 6 [/SUP], Kai Vahldiek[SUP] 6 [/SUP], Justin Hasenkamp[SUP] 7 [/SUP], Jonathan Kallusky[SUP] 7 [/SUP], Christine S Falk[SUP] 2 8 [/SUP], Tobias R Overbeck[SUP] #[/SUP][SUP] 7 [/SUP], Stephanie Heinemann[SUP] #[/SUP][SUP] 3 [/SUP]
Affiliations
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.
Keywords: COVID-19; Checkpoint inhibition; Coronavirus; Elderly; Hematology; Humoral and cellular immunity; Immunocompromised people; Immunogenicity; Pandemic; SARS-CoV-2; Serological testing; Social participation; Solid tumor.
. 2022 Apr 25;22(1):403.
doi: 10.1186/s12879-022-07347-w.
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
Alexandra Dopfer-Jablonka[SUP] #[/SUP][SUP] 1 2 [/SUP], Sandra Steffens[SUP] #[/SUP][SUP] 1 [/SUP], Frank Müller[SUP] #[/SUP][SUP] 3 [/SUP], Marie Mikuteit[SUP] 1 [/SUP], Jacqueline Niewolik[SUP] 1 [/SUP], Anne Cossmann[SUP] 1 [/SUP], Metodi V Stankov[SUP] 1 [/SUP], Georg M N Behrens[SUP] 1 2 4 [/SUP], Eva Hummers[SUP] 3 [/SUP], Gloria Heesen[SUP] 3 [/SUP], Dominik Schröder[SUP] 5 [/SUP], Sascha Roder[SUP] 3 [/SUP], Frank Klawonn[SUP] 2 6 [/SUP], Kai Vahldiek[SUP] 6 [/SUP], Justin Hasenkamp[SUP] 7 [/SUP], Jonathan Kallusky[SUP] 7 [/SUP], Christine S Falk[SUP] 2 8 [/SUP], Tobias R Overbeck[SUP] #[/SUP][SUP] 7 [/SUP], Stephanie Heinemann[SUP] #[/SUP][SUP] 3 [/SUP]
Affiliations
- PMID: 35468758
- DOI: 10.1186/s12879-022-07347-w
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.
Keywords: COVID-19; Checkpoint inhibition; Coronavirus; Elderly; Hematology; Humoral and cellular immunity; Immunocompromised people; Immunogenicity; Pandemic; SARS-CoV-2; Serological testing; Social participation; Solid tumor.