Clinical Trial Results:
A Phase IV Vaccine Study under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2/Covid-19 vaccines (ENFORCE PLUS)
Summary
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EudraCT number |
2021-003188-90 |
Trial protocol |
DK |
Global end of trial date |
31 Dec 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Feb 2025
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First version publication date |
28 Feb 2025
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Other versions |
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Summary report(s) |
End Note |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ENFORCE-PLUS
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT06360744 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
CHIP - Rigshospitalet - University of Copenhagen
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Sponsor organisation address |
Blegdamsvej 9, Section 2100, Copenhagen, Denmark, 2100
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Public contact |
Jens Lundgren, CHIP - Rigshospitalet, University of Copenhagen, 45 3545 5757, jens.lundgren@regionh.dk
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Scientific contact |
Jens Lundgren, CHIP - Rigshospitalet, University of Copenhagen, 45 3545 5757, jens.lundgren@regionh.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Dec 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Dec 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Dec 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of the study is to clarify whether vaccination with the Johnson & Johnson/Janssen vaccine leads to changes in the number and activation of platelets as well as anti-PF4 level and to compare whether the Johnson & Johnson/Janssen vaccine causes a stronger activation of platelets as well as an increase in anti-PF4 antibodies than mRNA vaccines
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Protection of trial subjects |
Informed Consent is obtained from the participant before any trial -related procedures were conducted.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
21 Jun 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 25
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Worldwide total number of subjects |
25
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EEA total number of subjects |
25
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
25
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The Danish COVID-19 vaccination programme does not include vaccination with the SARS-CoV-2 vaccine from Janssen, however vaccination with this vaccine is approved via a medical prescription. The ENFORCE PLUS protocol is proposed to be linked to ENFORCE with additional safety measures introduced the first month after vaccination. | ||||||
Pre-assignment
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Screening details |
The difference between the ENFORCE trial (EudraCT no.2020-006003) and this ENFORCE PLUS trial was the J&J vaccine was given by the trial staff and the ENFORCE participants received their vaccination in the Danish Vaccination Programme. | ||||||
Period 1
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Period 1 title |
Entire trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Vaccine Janssen | ||||||
Arm description |
The vaccine is used according to the approved Summary of Product Characteriestics. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Jcovden.
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Investigational medicinal product code |
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Other name |
Janssen/Johnson & Johnson CoV-2 vaccine
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
The vaccine is used according to the approved Summary of Product.
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Baseline characteristics reporting groups
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Reporting group title |
Entire trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Vaccine Janssen
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Reporting group description |
The vaccine is used according to the approved Summary of Product Characteriestics. |
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End point title |
Antibody Level [1] | ||||||||||||
End point description |
Primary Outcome: Minimal protective neutralising antibody titre (MPNAT) i.e. the minimum level of neutralising antibodies sufficient to protect the person from becoming infected.
MPNAT will be measured via profiling of antibodies against SARS-CoV-2 Spike epitopes performed at each visit until month 60.
We will use two different large-scale methods.
1. ELISA detection of total serum Ig to the Receptor Binding Domain (Wantai), this specific method will be stopped after January 2023 as the positive rate has reached 99%.
2. A multiantigen serological test including both the N-terminal Domain (NTD), The Receptor Binding Domain (RBD), the complete Spike (S) protein and the Nucleocapsid (NC) protein as antigens (from
Mesoscale).
Additionally, an ACE2 competition assay will be used to score the receptor blocking potential of antibodies raised by vaccination (Mesoscale).
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End point type |
Primary
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End point timeframe |
Antibody level will be measured via profiling of antibodies against SARS-CoV-2 Spike epitopes performed at each visit until month 24
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The statistical analysis are described in the ENFORCE trial |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
3 month after vaccination.
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Assessment type |
Systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
24.1
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Reporting groups
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Reporting group title |
Vaccine Janssen
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Reporting group description |
Number of persons with at least one Adverse Event reported | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 4% | |||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Since all 25 participants had completed their thir visit (3 month after vaccination) and already were in the follow-up phase, completely identical to the ENFORCE protocoll the participants were transferred for their follow-up to the ENFORCE database. |