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    Clinical Trial Results:
    Vaccine response against SARS-CoV-2 in patients with primary Sjögren’s syndrome

    Summary
    EudraCT number
    		 2021-001414-10
    Trial protocol
    		 NL  
    Global end of trial date
    23 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jan 2023
    First version publication date
    08 Jan 2023
    Other versions
    Summary report(s)
    		 Final report VaccineSS study

    Trial information

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    Trial identification
    Sponsor protocol code
    202100076
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Medical Center Groningen
    Sponsor organisation address
    Hanzeplein 1, Groningen, Netherlands, 9713GZ
    Public contact
    Postdoctoral researcher, University Medical Center Groningen, g.m.p.j.verstappen@umcg.nl
    Scientific contact
    Postdoctoral researcher, University Medical Center Groningen, g.m.p.j.verstappen@umcg.nl
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Nov 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to study protective antibody responses after SARS-CoV-2 vaccination in patients with pSS.
    Protection of trial subjects
    This study investigates the immune response and AEs in patients with pSS compared with healthy individuals. If subjects had not participated in this study, they still would have received the vaccine against SARS-CoV-2 according to standard of care via their general practitioner or area health authority without additional testing. The participant burden (questionnaires, saliva collection and blood drawing) were kept to a minimum to answer all research questions.
    Background therapy
    		 Background therapy was allowed, except for: - current use of conventional or biological DMARDs (hydroxychloroquine was allowed) - prednisone >10 mg/day - previous use of DMARDs ≤6 months before inclusion (rituximab ≤12 months)
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 104
    Worldwide total number of subjects
    104
    EEA total number of subjects
    104
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    71
    From 65 to 84 years
    33
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients with pSS who participated in the REgistry of Sjögren syndrome in Umcg – LongiTudinal (RESULT)-cohort were screened for in- and exclusion criteria. Potentially eligible patients received a letter with study information.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 pSS patients
    Arm description
    		 Patients with primary Sjögren's syndrome
    Arm type
    		 patient group

    Investigational medicinal product name
    Comirnaty COVID-19 mRNA vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A course of 2 doses (0.3 mL each)

    Investigational medicinal product name
    ChAdOx1-S COVID-19 vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A course of 2 doses (0.5 mL each)

    Investigational medicinal product name
    Ad26.COV2-S COVID-19 vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single-dose of 0.5 mL

    Investigational medicinal product name
    Spikevax COVID-19 mRNA vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A course of 2 doses (0.5 mL each)

    Arm title
    		 Healthy controls
    Arm description
    		 Female healthy controls
    Arm type
    		 healthy control group

    Investigational medicinal product name
    Comirnaty COVID-19 mRNA vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A course of 2 doses (0.3 mL each)

    Investigational medicinal product name
    ChAdOx1-S COVID-19 vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A course of 2 doses (0.5 mL each)

    Investigational medicinal product name
    Ad26.COV2-S COVID-19 vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single-dose of 0.5 mL

    Investigational medicinal product name
    Spikevax COVID-19 mRNA vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A course of 2 doses (0.5 mL each)

    Number of subjects in period 1
    		pSS patients Healthy controls
    Started
    70
    34
    Completed
    67
    33
    Not completed
    3
    1
         Consent withdrawn by subject
    1
    1
         Protocol deviation
    2
    -

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    pSS patients
    Reporting group description
    		 Patients with primary Sjögren's syndrome

    Reporting group title
    Healthy controls
    Reporting group description
    		 Female healthy controls

    Primary: Absolute difference in protective antibody titers against SARS-CoV-2 between patients with pSS and healthy controls

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    End point title
    		 Absolute difference in protective antibody titers against SARS-CoV-2 between patients with pSS and healthy controls [1]
    End point description
    End point type
    Primary
    End point timeframe
    Day 28 after the second vaccination
    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: Because of an unequal distribution of vaccination products between arms (e.g., more Spikevax in the healthy control arm), statistical comparison of two arms is not valid. We did statistically compare the two arms for each vaccination product. For details we refer to: Verstappen GM, de Wolff L, Arends S, et al. Immunogenicity and safety of COVID-19 vaccination in patients with primary Sjögren’s syndrome. RMD Open 2022;8:e002265. doi:10.1136/rmdopen-2022-002265
    End point values
    		 pSS patients Healthy controls
    Number of subjects analysed
    63
    29
    Units: AU/mL
        median (inter-quartile range (Q1-Q3))
    97230 (60247 to 224608)
    110710 (16771 to 280630)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    7 days after each vaccination. Periodic (quarterly) assessment of SAEs during follow-up specifically for ChAdOx1-S according to contract with AstraZeneca (one of the subsidising parties).
    Adverse event reporting additional description
    One patient with an SAE was excluded from the primary and secondary analyses, because of a screening failure. This patient is however included in the current adverse events report, resulting in a total of 68 participants in the pSS group.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    pSS patients
    Reporting group description
    		 -

    Reporting group title
    Healthy controls
    Reporting group description
    		 -

    Serious adverse events
    		 pSS patients Healthy controls
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 68 (2.94%)
    0 / 33 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Chest pain
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 pSS patients Healthy controls
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 68 (76.47%)
    17 / 33 (51.52%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    43 / 68 (63.24%)
    15 / 33 (45.45%)
         occurrences all number
    63
    18
    Pyrexia
         subjects affected / exposed
    7 / 68 (10.29%)
    4 / 33 (12.12%)
         occurrences all number
    8
    4
    Chills
         subjects affected / exposed
    17 / 68 (25.00%)
    7 / 33 (21.21%)
         occurrences all number
    20
    7
    Headache
         subjects affected / exposed
    37 / 68 (54.41%)
    12 / 33 (36.36%)
         occurrences all number
    49
    13
    Myalgia
         subjects affected / exposed
    28 / 68 (41.18%)
    12 / 33 (36.36%)
         occurrences all number
    41
    16
    Nausea
         subjects affected / exposed
    10 / 68 (14.71%)
    4 / 33 (12.12%)
         occurrences all number
    13
    4
    Gastrointestinal disorders
    Burning mouth syndrome
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    13 / 68 (19.12%)
    3 / 33 (9.09%)
         occurrences all number
    17
    3
    Product issues
    Injection site rash
         subjects affected / exposed
    10 / 68 (14.71%)
    3 / 33 (9.09%)
         occurrences all number
    10
    3
    Injection site oedema
    Additional description: At the site of injection
         subjects affected / exposed
    13 / 68 (19.12%)
    4 / 33 (12.12%)
         occurrences all number
    14
    5
    Injection site pain
         subjects affected / exposed
    43 / 68 (63.24%)
    16 / 33 (48.48%)
         occurrences all number
    61
    24

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Nov 2021
    - Addition of Spikevax to the investigational products - Addition of AstraZeneca as subsidising party and according to contract ChAdOx1-S COVID-19 vaccine SAE reporting during follow-up

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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