SARS CoV 2 InfectionPhase 4NCT06360744
A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 (COVID-19) Vaccines.
A Phase 4 study testing Johnson & Johnson in people with SARS CoV 2 Infection, run by Jens D Lundgren, MD at 5 sites in Denmark.
Trial summary
A phase IV study to assess if the SARS-CoV-2 vaccine from Johnson \& Johnson/Janssen (J\&J) results in change in number and activation of platelets and anti-PF4 Level. As well as compare whether the vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS CoV 2 Infection
- What is being tested?
- Johnson & Johnson
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesDenmark
- Study dates
- 5 Jul 2021to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent obtained before any trial related procedures are performed
- Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the 'Tilvalgsordningen')
- The subject must be willing and able to comply with trial protocol (re-visits and biological samples)
Who cannot join
- Male and female under the age of 18
- Any subgroup of individuals for which the vaccine is contra-indicated
- Previous SARS-CoV-2 vaccination
- Specific for the Johnson \& Johnson vaccine:
- Experience of a serious allergic reaction after injection of any other vaccine
- Serious infection with high fever (> 38 0C) A temporary postponement of the vaccination is allowed, when participant has been well for at least 48 hours. Mild fever or upper airway infection like a cold is not a problem
- Problems with bleeding or bruising, or use of anticoagulant medicine (to prevent blood clots)
- Immunodeficiency or use of medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Aalborg Universitetshospital Syd
Aalborg, 8000
Aarhus Universitetshospital, Skejby
Aarhus, Aarhus N, 8200
Hvidovre Hospital
Hvidovre, 2600
Odense Universitetshospital
Odense, 5000
Sjællandsuniversitetshospital
Roskilde, 4000
About this study
Official title: A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 (COVID-19) Vaccines (ENFORCE PLUS)
A phase IV study to assess if the SARS-CoV-2 vaccine from Johnson \& Johnson/Janssen (J\&J) results in change in number and activation of platelets and anti-PF4 Level. As well as compare whether the vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines.
The Danish Medicines Agency has approved the vaccine from J\&J for use in Denmark, however it is not currently part of the national vaccine programme.
The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls. A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent).
Read the detailed description
Participants will have 3 specific study visits and will hereafter be followed for 2 years after the vaccination with regular visits after 3, 6, 12 and 24 month. In this way the participants will be offered an extra close follow up on vaccine effectiveness.
Safety data will be collected at study visits until 3 months after the first vaccination,, with additional safety data collected under this protocol during the first month after vaccination.
Research samples will be collected at each study visit during the two-year follow-up.
- Conditions
- SARS CoV 2 Infection
- Being tested
- Johnson & Johnson
- Keywords
- COVID-19, Vaccination
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Johnson & JohnsonBiological
Vaccination with the Johnson \& Johnson vaccine which is NOT part of the Danish National Government programme
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Johnson and Johnson/Janssen Covid-19 vaccine | Other | Johnson \& Johnson/Janssen Covid-19 vaccine. Receives: Biological: Johnson & Johnson |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the J& J vaccine
To clarify whether vaccination with the J\&J vaccine leads to changes in the number and activation of platelets as well as anti-PF4 level and to compare whether the J\&J vaccine causes a stronger activation of platelets as well as an increase in anti-PF4 antibodies compared to mRNA vaccines. Included is also questionnaires
Measured: The change from base-line to after 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start5 Jul 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens D Lundgren, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of the Interior and Health, Denmark
- Responsible party
- Sponsor-investigator, Jens D Lundgren, MD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jens Lundgren, Professor, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360744
- Sponsor's protocol ID
- ENFORCE PLUS
- Status last verified
- Apr 2024
- First submitted
- 1 Jul 2021
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 (COVID-19) Vaccines (ENFORCE PLUS)
- ClinicalTrials.gov ID
- NCT06360744
- Acronym / sponsor ID
- ENFORCE PLUS
- Conditions
- SARS CoV 2 Infection
- Keywords
- COVID-19, Vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Jens D Lundgren, MDUniversity, hospital or other
- Collaborators
- Ministry of the Interior and Health, Denmark
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase IV study to assess if the SARS-CoV-2 vaccine from Johnson \& Johnson/Janssen (J\&J) results in change in number and activation of platelets and anti-PF4 Level. As well as compare whether the vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines.
The Danish Medicines Agency has approved the vaccine from J\&J for use in Denmark, however it is not currently part of the national vaccine programme.
The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls. A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent).
Detailed description
Participants will have 3 specific study visits and will hereafter be followed for 2 years after the vaccination with regular visits after 3, 6, 12 and 24 month. In this way the participants will be offered an extra close follow up on vaccine effectiveness.
Safety data will be collected at study visits until 3 months after the first vaccination,, with additional safety data collected under this protocol during the first month after vaccination.
Research samples will be collected at each study visit during the two-year follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls.
| Arm | Type | Receives |
|---|---|---|
| Vaccine Johnson and Johnson/Janssen Covid-19 vaccine | Other | Biological: Johnson & JohnsonJohnson \& Johnson/Janssen Covid-19 vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent obtained before any trial related procedures are performed
- Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the 'Tilvalgsordningen')
- The subject must be willing and able to comply with trial protocol (re-visits and biological samples)
Key exclusion criteria (8 listed)
- Male and female under the age of 18
- Any subgroup of individuals for which the vaccine is contra-indicated
- Previous SARS-CoV-2 vaccination
- Experience of a serious allergic reaction after injection of any other vaccine
- Serious infection with high fever (> 38 0C) A temporary postponement of the vaccination is allowed, when participant has been well for at least 48 hours. Mild fever or upper airway infection like a cold is not a problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Johnson & JohnsonVaccination with the Johnson \& Johnson vaccine which is NOT part of the Danish National Government programme | Biological | Vaccine Johnson and Johnson/Janssen Covid-19 vaccine |
Primary outcome
Assessment of the J& J vaccine
Time frame: The change from base-line to after 24 month
To clarify whether vaccination with the J\&J vaccine leads to changes in the number and activation of platelets as well as anti-PF4 level and to compare whether the J\&J vaccine causes a stronger activation of platelets as well as an increase in anti-PF4 antibodies compared to mRNA vaccines. Included is also questionnaires
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Lundgren, Professor study chair
Copenhagen University Hospital, Rigshospitalet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Johnson & Johnson in people with SARS CoV 2 Infection, run by Jens D Lundgren, MD at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the J& J vaccine (time frame: The change from base-line to after 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.