Cohort Profile:The Danish National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE)
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 dur...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-12-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/12/e069065.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850037006365622272 |
|---|---|
| author | Kasper Karmark Iversen Henrik Nielsen Isik S Johansen Lykke larsen Lothar Wiese Thomas Benfield Lene Surland Knudsen Lars Østergaard Joanne Reekie Ole S Søgaard Jens Lundgren Britta Tarp Kamille Fogh Nina Breinholt Stærke Martin Tolstrup Fredrikke Dam Larsen Susan Olaf Lindvig Inge Kristine Holden Mette Brouw Iversen Marie Louise Jakobsen Anna Katrin Traytel |
| author_facet | Kasper Karmark Iversen Henrik Nielsen Isik S Johansen Lykke larsen Lothar Wiese Thomas Benfield Lene Surland Knudsen Lars Østergaard Joanne Reekie Ole S Søgaard Jens Lundgren Britta Tarp Kamille Fogh Nina Breinholt Stærke Martin Tolstrup Fredrikke Dam Larsen Susan Olaf Lindvig Inge Kristine Holden Mette Brouw Iversen Marie Louise Jakobsen Anna Katrin Traytel |
| author_sort | Kasper Karmark Iversen |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-eea6683cee8a437db2115267f6b00e23 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-eea6683cee8a437db2115267f6b00e232025-08-20T02:56:59ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2022-069065Cohort Profile:The Danish National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE)Kasper Karmark Iversen0Henrik Nielsen1Isik S Johansen2Lykke larsen3Lothar Wiese4Thomas Benfield5Lene Surland Knudsen6Lars Østergaard7Joanne Reekie8Ole S Søgaard9Jens Lundgren10Britta Tarp11Kamille Fogh12Nina Breinholt Stærke13Martin Tolstrup14Fredrikke Dam Larsen15Susan Olaf Lindvig16Inge Kristine Holden17Mette Brouw Iversen18Marie Louise Jakobsen19Anna Katrin Traytel20Department of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDepartment of Infectious Diseases, Aalborg University Hospital, Aalborg, DenmarkDepartment of Infectious Diseases, Odense Universitetshospital, Odense, Denmark3 Department of Infectious Diseases, Odense University Hospital, Odense, Denmark5 Department of Infectious Diseases, Roskilde Hospital, Roskilde, DenmarkDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDepartment of Medicine, Zealand University Hospital, Roskilde, DenmarkDepartment of Infectious Diseases, Aarhus University Hospital, Aarhus, DenmarkCenter of Excellence for Health, Immunity and Infections, Rigshospitalet, University of Copenhagen, Kobenhavn, DenmarkDepartment of Infectious Diseases, Aarhus University Hospital, Aarhus, DenmarkCenter of Excellence for Health, Immunity and Infections, Rigshospitalet, University of Copenhagen, Kobenhavn, DenmarkDiagnostic Centre, Silkeborg Regional Hospital, Silkeborg, DenmarkDepartment of Cardiology, Copenhagen University Hospital, Herlev and Gentofte, Copenhagen, DenmarkDepartment of Infectious Diseases, Aarhus University Hospital, Aarhus, DenmarkDepartment of Infectious Diseases, Aarhus University Hospital, Aarhus, DenmarkDepartment of Infectious Diseases, Aarhus University Hospital, Aarhus, DenmarkDepartment of Infectious Diseases, Odense Universitetshospital, Odense, DenmarkDepartment of Infectious Diseases, Odense Universitetshospital, Odense, DenmarkDepartment of Medicine, Zealand University Hospital, Roskilde, DenmarkCenter of Excellence for Health, Immunity and Infections, Rigshospitalet, University of Copenhagen, Kobenhavn, DenmarkCenter of Excellence for Health, Immunity and Infections, Rigshospitalet, University of Copenhagen, Kobenhavn, DenmarkPurpose 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.https://bmjopen.bmj.com/content/12/12/e069065.full |
| spellingShingle | Kasper Karmark Iversen Henrik Nielsen Isik S Johansen Lykke larsen Lothar Wiese Thomas Benfield Lene Surland Knudsen Lars Østergaard Joanne Reekie Ole S Søgaard Jens Lundgren Britta Tarp Kamille Fogh Nina Breinholt Stærke Martin Tolstrup Fredrikke Dam Larsen Susan Olaf Lindvig Inge Kristine Holden Mette Brouw Iversen Marie Louise Jakobsen Anna Katrin Traytel Cohort Profile:The Danish National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE) BMJ Open |
| title | Cohort Profile:The Danish National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE) |
| title_full | Cohort Profile:The Danish National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE) |
| title_fullStr | Cohort Profile:The Danish National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE) |
| title_full_unstemmed | Cohort Profile:The Danish National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE) |
| title_short | Cohort Profile:The Danish National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE) |
| title_sort | cohort profile the danish national cohort study of effectiveness and safety of sars cov 2 vaccines enforce |
| url | https://bmjopen.bmj.com/content/12/12/e069065.full |
| work_keys_str_mv | AT kasperkarmarkiversen cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT henriknielsen cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT isiksjohansen cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT lykkelarsen cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT lotharwiese cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT thomasbenfield cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT lenesurlandknudsen cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT larsøstergaard cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT joannereekie cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT olessøgaard cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT jenslundgren cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT brittatarp cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT kamillefogh cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT ninabreinholtstærke cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT martintolstrup cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT fredrikkedamlarsen cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT susanolaflindvig cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT ingekristineholden cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT mettebrouwiversen cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT marielouisejakobsen cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce AT annakatrintraytel cohortprofilethedanishnationalcohortstudyofeffectivenessandsafetyofsarscov2vaccinesenforce |