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.
COVID-19
Checkpoint inhibition
Coronavirus
Elderly
Hematology
Humoral and cellular immunity
Immunocompromised people
Immunogenicity
Pandemic
SARS-CoV-2
Serological testing
Social participation
Solid tumor
Journal
BMC infectious diseases
ISSN: 1471-2334
Titre abrégé: BMC Infect Dis
Pays: England
ID NLM: 100968551
Informations de publication
Date de publication:
25 Apr 2022
25 Apr 2022
Historique:
received:
20
03
2022
accepted:
04
04
2022
entrez:
26
4
2022
pubmed:
27
4
2022
medline:
28
4
2022
Statut:
epublish
Résumé
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. 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). (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. 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. This study was registered with German Clinical Trial Registry (registration number: DRKS00023972) on 30th December 2020.
Sections du résumé
BACKGROUND
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
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
METHODS
(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
CONCLUSIONS
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
BACKGROUND
This study was registered with German Clinical Trial Registry (registration number: DRKS00023972) on 30th December 2020.
Identifiants
pubmed: 35468758
doi: 10.1186/s12879-022-07347-w
pii: 10.1186/s12879-022-07347-w
pmc: PMC9035970
doi:
Substances chimiques
COVID-19 Vaccines
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
403Subventions
Organisme : European Regional Development Fund
ID : ZW7-85152953
Organisme : Förderschwerpunktprogramm des COVID-19 Forschungsnetzwerks Niedersachsen (COFONI)
ID : 8FT21
Informations de copyright
© 2022. The Author(s).
Références
J Crohns Colitis. 2022 Mar 14;16(3):389-397
pubmed: 34473254
Arthritis Care Res (Hoboken). 2014 Jul;66(7):1016-26
pubmed: 24339395
JAMA. 2020 May 26;323(20):2052-2059
pubmed: 32320003
J Rheumatol. 2018 Jun;45(6):733-744
pubmed: 29545454
N Engl J Med. 2020 Jun 18;382(25):2475-2477
pubmed: 32329975
Euro Surveill. 2021 Oct;26(41):
pubmed: 34651577
Lancet Gastroenterol Hepatol. 2020 Jul;5(7):643-644
pubmed: 32339474
Ann Rheum Dis. 2021 Oct;80(10):1339-1344
pubmed: 34035003
J Affect Disord. 2010 Apr;122(1-2):86-95
pubmed: 19616305
Am J Transplant. 2020 Jul;20(7):1819-1825
pubmed: 32351040
Ann Intern Med. 2007 Mar 6;146(5):317-25
pubmed: 17339617
Leukemia. 2020 Jun;34(6):1637-1645
pubmed: 32332856
Lancet Rheumatol. 2021 Sep;3(9):e627-e637
pubmed: 34258590
Lancet. 2020 Feb 15;395(10223):470-473
pubmed: 31986257
Nat Med. 2021 Apr;27(4):626-631
pubmed: 33692530
Ann Rheum Dis. 2020 Jul;79(7):859-866
pubmed: 32471903
Ann Rheum Dis. 2019 Feb;78(2):282-284
pubmed: 30297326
Clin Rheumatol. 2021 Feb;40(2):797-798
pubmed: 33426632
Am J Transplant. 2020 Jul;20(7):1800-1808
pubmed: 32330343