tetano
Editor, Senior Moderator
BMJ Open
. 2022 Dec 30;12(12):e069065.
doi: 10.1136/bmjopen-2022-069065.
Cohort Profile:The Danish National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE)
Nina Breinholt Stærke[SUP] 1 2 [/SUP], Joanne Reekie[SUP] 3 [/SUP], Isik S Johansen[SUP] 4 5 [/SUP], Henrik Nielsen[SUP] 6 7 [/SUP], Thomas Benfield[SUP] 8 9 [/SUP], Lothar Wiese[SUP] 10 [/SUP], Ole S Søgaard[SUP] 11 2 [/SUP], Martin Tolstrup[SUP] 11 2 [/SUP], Kasper Karmark Iversen[SUP] 9 12 [/SUP], Britta Tarp[SUP] 13 [/SUP], Fredrikke Dam Larsen[SUP] 11 2 [/SUP], Lykke Larsen[SUP] 4 5 [/SUP], Susan Olaf Lindvig[SUP] 4 [/SUP], Inge Kristine Holden[SUP] 4 [/SUP], Mette Brouw Iversen[SUP] 10 [/SUP], Lene Surland Knudsen[SUP] 10 [/SUP], Kamille Fogh[SUP] 12 [/SUP], Marie Louise Jakobsen[SUP] 3 [/SUP], Anna Katrin Traytel[SUP] 3 [/SUP], Lars Ostergaard[SUP] 11 2 [/SUP], Jens Lundgren[SUP] 3 [/SUP]; ENFORCE Study Group
Affiliations
Abstract
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.
Keywords: COVID-19; IMMUNOLOGY; Infection control.
. 2022 Dec 30;12(12):e069065.
doi: 10.1136/bmjopen-2022-069065.
Cohort Profile:The Danish National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE)
Nina Breinholt Stærke[SUP] 1 2 [/SUP], Joanne Reekie[SUP] 3 [/SUP], Isik S Johansen[SUP] 4 5 [/SUP], Henrik Nielsen[SUP] 6 7 [/SUP], Thomas Benfield[SUP] 8 9 [/SUP], Lothar Wiese[SUP] 10 [/SUP], Ole S Søgaard[SUP] 11 2 [/SUP], Martin Tolstrup[SUP] 11 2 [/SUP], Kasper Karmark Iversen[SUP] 9 12 [/SUP], Britta Tarp[SUP] 13 [/SUP], Fredrikke Dam Larsen[SUP] 11 2 [/SUP], Lykke Larsen[SUP] 4 5 [/SUP], Susan Olaf Lindvig[SUP] 4 [/SUP], Inge Kristine Holden[SUP] 4 [/SUP], Mette Brouw Iversen[SUP] 10 [/SUP], Lene Surland Knudsen[SUP] 10 [/SUP], Kamille Fogh[SUP] 12 [/SUP], Marie Louise Jakobsen[SUP] 3 [/SUP], Anna Katrin Traytel[SUP] 3 [/SUP], Lars Ostergaard[SUP] 11 2 [/SUP], Jens Lundgren[SUP] 3 [/SUP]; ENFORCE Study Group
Affiliations
- PMID: 36585137
- DOI: 10.1136/bmjopen-2022-069065
Abstract
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.
Keywords: COVID-19; IMMUNOLOGY; Infection control.