RT Journal Article
SR Electronic
T1 Cohort Profile:The Danish National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE)
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e069065
DO 10.1136/bmjopen-2022-069065
VO 12
IS 12
A1 Nina Breinholt Stærke
A1 Joanne Reekie
A1 Isik S Johansen
A1 Henrik Nielsen
A1 Thomas Benfield
A1 Lothar Wiese
A1 Ole S Søgaard
A1 Martin Tolstrup
A1 Kasper Karmark Iversen
A1 Britta Tarp
A1 Fredrikke Dam Larsen
A1 Lykke Larsen
A1 Susan Olaf Lindvig
A1 Inge Kristine Holden
A1 Mette Brouw Iversen
A1 Lene Surland Knudsen
A1 Kamille Fogh
A1 Marie Louise Jakobsen
A1 Anna Katrin Traytel
A1 Lars Ostergaard
A1 Jens Lundgren
A1 ,
YR 2022
UL http://bmjopen.bmj.com/content/12/12/e069065.abstract
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.