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    Clinical Trial Results:
    A low-interventional study to investigate the efficacy and safety of SARS-CoV-2 vaccines in patients with rheumatic diseases.

    Summary
    EudraCT number
    		 2021-002245-15
    Trial protocol
    		 DE  
    Global end of trial date
    11 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Dec 2025
    First version publication date
    11 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CCM-RNT-202102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité Universitätsmedizin Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Rheumatologie Studienabteilung: David Simon, Medizinische KLinik mit Schwerpunkt Rheumatologie und klinische Immunologie, 0049 30450513025, rheumastudien@charite.de
    Scientific contact
    Rheumatologie Studienabteilung: David Simon, Medizinische KLinik mit Schwerpunkt Rheumatologie und klinische Immunologie, 0049 30450513025, rheumastudien@charite.de
    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
    01 Jun 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To identify AIRD-specific variables that influence the expression and duration of vaccine protection following SARS-CoV-2 vaccination.
    Protection of trial subjects
    The conduct of this study met all legal and regulatory requirements and in accordance with ethical principles of the Declaration of Helsinki.
    Background therapy
    		 Patients with autoimmune rheumatic diseases (AIRD) are at a slightly higher risk for infection with SARS-CoV- 2 and for a more severe outcome of COVID-19 compared with healthy individuals. However, it is also known that vaccination effectiveness can be reduced in patients with AIRD,2 3 raising the need for a strategy to identify patients who might benefit from antibody testing and additional vaccine doses. Since patients with AIRD have been largely excluded from the vaccination registration studies, data needed to be collected to fill the knowledge gap regarding COVID-19 vaccination in rheumatic patients. We therefore aimed to identify the factors that lead to a diminished humoral response and investigated the immunogenicity of different COVID-19 vaccines in a large cohort of patients with AIRD, using an immunocom-petent control group (IC) for comparison.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 May 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 604
    Worldwide total number of subjects
    604
    EEA total number of subjects
    604
    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)
    565
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 394 patients were initial recruited. Than 86 patient were excluded for protocol deviations. Clinical characterization and blood sampling took place between June and September 2021 at Charité site, and the stored blood samples were collected in April and May 2021 among patients with AIRD .

    Pre-assignment
    Screening details
    		 1) Participants had to meet the following inclusion criteria: age 18 years or older, AIRD diagnosis and vaccination with a COVID-19 vaccine authorised for use in Germany. 2) Participants (immunocompetent controls- helathcare workers and elderly patients) from 3 other cohort studies (EICOV, COVIMMUNIZE, COVIM) conducted at Charité

    Period 1
    Period 1 title
    overall trail (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Observational study with research blood sampling as the one and only intervention.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AIRD group
    Arm description
    		 This group includes: inflammatory joint diseases, connective tissue diseases/myositis, vasculitis, and other rheumatic autoimmune diseases.
    Arm type
    		 Experimental

    Investigational medicinal product name
    COVID-19 mRNA vaccine - BioNtech
    Investigational medicinal product code
    BNT162b2
    Other name
    Comirnaty
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    xxx

    Investigational medicinal product name
    COVID-19 vaccine-AstraZeneca
    Investigational medicinal product code
    AZD1222
    Other name
    Vaxzevria
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    xxx

    Investigational medicinal product name
    COVID-19 Vaccine Moderna
    Investigational medicinal product code
    mRNA-1273
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    xxx

    Arm title
    		 control group
    Arm description
    		 healthy participants received vaccination with two doses of AZD1222 and a short time period between administration of first and second vaccination
    Arm type
    		 Active comparator

    Investigational medicinal product name
    COVID-19 mRNA vaccine - BioNtech
    Investigational medicinal product code
    BNT162b2
    Other name
    Comirnaty
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    N/A

    Investigational medicinal product name
    COVID-19 vaccine-AstraZeneca
    Investigational medicinal product code
    AZD1222
    Other name
    Vaxzevria
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    N/A

    Number of subjects in period 1
    		AIRD group control group
    Started
    308
    296
    Completed
    308
    296

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AIRD group
    Reporting group description
    		 This group includes: inflammatory joint diseases, connective tissue diseases/myositis, vasculitis, and other rheumatic autoimmune diseases.

    Reporting group title
    control group
    Reporting group description
    		 healthy participants received vaccination with two doses of AZD1222 and a short time period between administration of first and second vaccination

    Reporting group values
    		 AIRD group control group Total
    Number of subjects
    		 308 296 604
    Age categorical
    Units: Subjects
        Age ≥60 years
    		 147 76 223
        Age <60 years
    		 161 220 381
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 59 (46.3 to 66.0) 40 (31.0 to 60.0) -
    Gender categorical
    Units: Subjects
        Female
    		 209 199 408
        Male
    		 99 97 196
    Comorbidities
    Units: Subjects
        Cardiovascular disease
    		 118 69 187
        Type 2 diabetes
    		 23 13 36
        Respiratory disease
    		 41 32 73
        no disease
    		 126 182 308

    End points

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    End points reporting groups
    Reporting group title
    AIRD group
    Reporting group description
    		 This group includes: inflammatory joint diseases, connective tissue diseases/myositis, vasculitis, and other rheumatic autoimmune diseases.

    Reporting group title
    control group
    Reporting group description
    		 healthy participants received vaccination with two doses of AZD1222 and a short time period between administration of first and second vaccination

    Primary: vaccination response.

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    End point title
    		 vaccination response. [1]
    End point description
    The threshold for positivity for anti-SARS-CoV-2 IgG levels was set at >1.00 S/ CO (signal/predefined cut-off of 30) in accordance with manufacturer’s instructions. All analyses were performed using neutralisation capacities as well as anti-RBD-IgG levels. Of the patients with AIRD, 84.4% had been vaccinated with two doses of an mRNA vaccine (BNT162b2, n=233; mRNA-1273, n=27), while 7.1% of patients had received two doses of AZD1222 (n=22) and 8.4% of patients one dose of AZD1222 followed by one dose of an mRNA vaccine (n=26). Patients with AIRD vaccinated with two doses of AZD1222 showed significantly lower neutralising capacity and anti-RBD-IgG levels (53.7%, 2.0 S/CO) than those vaccinated with mRNA based vaccines (BNT162b2: 90.7%, 5.5 S/CO; mRNA-1273:95.3%, 6.0 S/CO) or a heterologous vaccination scheme (94.4%, 6.0 S/CO).
    End point type
    Primary
    End point timeframe
    Antibody response was measured predominantly about 2–4 weeks after the second dose of vaccination. Maximum time from vaccination to blood taking was restricted to 60 days to avoid an influence of waning antibody responses. Vaccine interval range was 21–54
    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: For more details please visit the journal Rheumatic & Musculoskeletal Diseases (RMD) Open online (http:// dx. doi. org/ 10.1136/ rmdopen- 2022- 002650).
    End point values
    		 AIRD group control group
    Number of subjects analysed
    308
    296
    Units: neutralising capacity (%)
        median (inter-quartile range (Q1-Q3))
    90.8 (54.2 to 95.9)
    96.5 (93.5 to 97.1)
    No statistical analyses for this end point

    Primary: Anti-RBD-IgG-level

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    End point title
    		 Anti-RBD-IgG-level [2]
    End point description
    End point type
    Primary
    End point timeframe
    after 2 doses of vaccination
    Notes
    [2] - 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: For more details please visit the journal Rheumatic & Musculoskeletal Diseases (RMD) Open online (http:// dx. doi. org/ 10.1136/ rmdopen- 2022- 002650).
    End point values
    		 AIRD group control group
    Number of subjects analysed
    308
    296
    Units: S/CO
        median (inter-quartile range (Q1-Q3))
    5.6 (2.0 to 6.6)
    6.7 (6.3 to 7.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    overall trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 own
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Verum Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 296 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Verum Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 308 (0.00%)
    0 / 296 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events were reported , because only retrospective data were analyzed.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36597977
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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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