Clinical Trial Results:
Immune response after covid-19 vaccination in patients with renal failure stadium 4 or 5 .
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Summary
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EudraCT number |
2021-000988-68 |
Trial protocol |
SE |
Global end of trial date |
21 Jun 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Dec 2024
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First version publication date |
12 Dec 2024
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Other versions |
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Summary report(s) |
Cellular and humoral response to SARS-CoV-2 vaccine BNT162b2 in adults with Chronic Kidney Disease G45. |
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 |
O2021-1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Helena Hervius Askling
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Sponsor organisation address |
Ambulansgatan 12 B, Stockholm, Sweden, 14157
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Public contact |
Infektionskliniken , Region Örebro län, +46 0196021000, anja.rosdahl@regionorebrolan.se
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Scientific contact |
Infektionskliniken , Region Örebro län, +46 0196021000, anja.rosdahl@regionorebrolan.se
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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 |
10 Jun 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 Jun 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Jun 2022
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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 |
To investigate the proportion of patients with renal failure stadium 4 and 5, with or without dialysis, who have seroconverted 2 weeks after vaccine dose 2 or have at least 10^2 increase of neutralizing antibodies towards SARS-CoV-2 compared with baseline.
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Protection of trial subjects |
No specific protection of subjects, since all subjects were recommended the study drug (Covid-vaccine) in the national vaccine programme. Yet, all subjects reported side effects, and vaccination was postponed in some cases with severe side effects.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
15 Mar 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 |
Sweden: 29
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Worldwide total number of subjects |
29
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EEA total number of subjects |
29
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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) |
28
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
A list of potential participants were provided by physicians at the local clinc. Any potential participants who had already recieved 2 vaccine doses were excluded. The remaining were contacted by letter or phone and asked if they would like to participate in the study. Any healthy rfamily member willing to participate were used as control. | ||||||||||||||||||
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Pre-assignment
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Screening details |
43 subjects screened, 29 included in the study. | ||||||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
29 | ||||||||||||||||||
Number of subjects completed |
29 | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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CKD grade 4 and 5 | ||||||||||||||||||
Arm description |
Adult patients with CKD grad 4 to 5 | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Pfiezrs mRNA vaccin Cominarty
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for dispersion for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.3 ml ( 30 mikrogram ) / dose. Intramuscular injection in M deltoideus.
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Arm title
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Healthy control | ||||||||||||||||||
Arm description |
Healthy controls | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Pfiezrs mRNA vaccin Cominarty
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for dispersion for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.3 ml ( 30 mikrogram ) / dose. Intramuscular injection in M deltoideus.
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Baseline characteristics reporting groups
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Reporting group title |
CKD grade 4 and 5
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Reporting group description |
Adult patients with CKD grad 4 to 5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Healthy control
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Reporting group description |
Healthy controls | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
CKD grade 4 and 5
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Reporting group description |
Adult patients with CKD grad 4 to 5 | ||
Reporting group title |
Healthy control
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Reporting group description |
Healthy controls | ||
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End point title |
Proportion with seroconversion after second vaccine dose [1] | ||||||||||||
End point description |
The proportion of subjects who have seroconverted or have an 10^2 increase in Spike IgG antibodies 2 weeks after the second vaccine dose.
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End point type |
Primary
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End point timeframe |
2 weeks after the second vaccine dose
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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: A comparison of the proportion who seroconverted in each group not valid since 100% seroconverted i both groups. The absolut number of spike IgG was compared instead with Mann-Whitney, but their were no statistic difference in abslout numbers either. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Proportion with maintaied immunity at 3 months | ||||||||||||
End point description |
Proportion of subjects with meassurble Spike Ig G antibodies at 3 months following primary vaccination
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End point type |
Secondary
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End point timeframe |
3 month after primary vaccination
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Proportion with maintained immunity at 6 months | |||||||||
End point description |
Proportion of participants with meassurable Spike IgG antibodies 6 months following the primary vaccination
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End point type |
Secondary
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End point timeframe |
6 months after the primary vaccination
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| No statistical analyses for this end point | ||||||||||
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End point title |
Proportion with maintained immunity at 12 months | ||||||||||||
End point description |
The proportion of subjects with maintained immunity as in Spike IgG antibodies at 12 months followint primary immunization
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End point type |
Secondary
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End point timeframe |
12 months after primary immunization
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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 |
From start of trial , ie the first vaccine dose given unitl the last subject's last visit
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Adverse event reporting additional description |
SAE du to trauma, planned surgery or planned medical intervention, death or hospitalisation due to documented cancerrelated disease, and serious infection not in timer related to the immunization ( defined as > 4 weeks since vaccine was given) or not related to the location of injection was not reported as SAE.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
27.1
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Reporting groups
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Reporting group title |
CKD G4/5
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Reporting group description |
subjects with Chronic kindey disease grade 4 or 5. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
healthy controls
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Reporting group description |
Healthy controls | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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12 May 2021 |
Origanally the studie was suppose to include different arms for different covid vaccines, but before study start it was decided to only use Pfizers mRNA vaccine |
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01 Oct 2021 |
Due to new Swedish recommendations adding an extra vaccine dose in the primary vaccine schedule to patients with chronic kidney diseas G 5 with and without in dialysis, this was added to the protocol. |
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15 Feb 2022 |
Adding a booster dose to all participants according to the Swedish recommendations, including an extra ( fourth dose) to subjects with chronic kidney disease G 5 woth or wothout dialysis |
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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. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/39282145 |
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