PT  - JOURNAL ARTICLE
AU  - Nina Breinholt Stærke
AU  - Joanne Reekie
AU  - Isik S Johansen
AU  - Henrik Nielsen
AU  - Thomas Benfield
AU  - Lothar Wiese
AU  - Ole S Søgaard
AU  - Martin Tolstrup
AU  - Kasper Karmark Iversen
AU  - Britta Tarp
AU  - Fredrikke Dam Larsen
AU  - Lykke Larsen
AU  - Susan Olaf Lindvig
AU  - Inge Kristine Holden
AU  - Mette Brouw Iversen
AU  - Lene Surland Knudsen
AU  - Kamille Fogh
AU  - Marie Louise Jakobsen
AU  - Anna Katrin Traytel
AU  - Lars Ostergaard
AU  - Jens Lundgren
ED  - ,
TI  - Cohort Profile:The Danish National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE)
AID  - 10.1136/bmjopen-2022-069065
DP  - 2022 Dec 01
TA  - BMJ Open
PG  - e069065
VI  - 12
IP  - 12
4099  - http://bmjopen.bmj.com/content/12/12/e069065.short
4100  - http://bmjopen.bmj.com/content/12/12/e069065.full
SO  - BMJ Open2022 Dec 01; 12
AB  - Purpose The ENFORCE cohort is a national Danish prospective cohort of adults who received a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine as part of the Danish National SARS-CoV-2 vaccination programme. It was designed to investigate the long-term effectiveness, safety and durability of SARS-CoV-2 vaccines used in Denmark.Participants A total of 6943 adults scheduled to receive a SARS-CoV-2 vaccine in the Danish COVID-19 vaccination programme were enrolled in the study prior to their first vaccination. Participants will be followed for a total of 2 years with five predetermined follow-up visits and additional visits in relation to any booster vaccination. Serology measurements are performed after each study visit. T-cell immunity is evaluated at each study visit for a subgroup of 699 participants. Safety information is collected from participants at visits following each vaccination. Data on hospital admissions, diagnoses, deaths and SARS-CoV-2 PCR results are collected from national registries throughout the study period. The median age of participants was 64 years (IQR 53–75), 56.6% were women and 23% were individuals with an increased risk of a serious course of COVID-19. A total of 340 (4.9%) participants tested positive for SARS-CoV-2 spike IgG at baseline.Findings to date Results have been published on risk factors for humoral hyporesponsiveness and non-durable response to SARS-CoV-2 vaccination, the risk of breakthrough infections at different levels of SARS-CoV-2 spike IgG by viral variant and on the antibody neutralising capacity against different SARS-CoV-2 variants following primary and booster vaccinations.Future plans The ENFORCE cohort will continuously generate studies investigating immunological response, effectiveness, safety and durability of the SARS-CoV-2 vaccines.Trial registration number NCT04760132.Data may be made available to researchers upon approval of an application to the scientific steering committee of the ENFORCE study. More information about data access may be found at https://chip.dk/Research/Studies/ENFORCE/Study-Governance.