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    Clinical Trial Results:
    CoVacc - Immune response to vaccination against Covid-19, an open multicenter phase IV study

    Summary
    EudraCT number
    		 2021-000683-30
    Trial protocol
    		 SE  
    Global end of trial date
    08 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2025
    First version publication date
    14 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CoVacc
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Umeå University
    Sponsor organisation address
    UNIVERSITETSTORGET 4, Umeå, Sweden,
    Public contact
    Clas Ahlm, Umeå university, +46 0907850000, clas.ahlm@umu.se
    Scientific contact
    Clas Ahlm, Umeå university, +46 0907850000, clas.ahlm@umu.se
    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
    27 Jan 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jan 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Does antibody development to SARS-CoV-2 S protein differ after vaccination between those who have had a previous SARS-CoV-2 infection compared to Covid-19 naive individuals?
    Protection of trial subjects
    The study participants were followed after vaccination for Covid 19. The vaccination was done according to clinical routine and the national coordination so the vaccines used was not a part of the study protocol. All participants were asked about adverse events at study visits 3 months after the vaccine dose was given. All SUSAR were reported accordning to protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Mar 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
    Sweden: 773
    Worldwide total number of subjects
    773
    EEA total number of subjects
    773
    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)
    603
    From 65 to 84 years
    138
    85 years and over
    32

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited via national coordinated vaccination units. They were given information and time to read the written information about the study before signing the informed concent. Before given their Covid 19 vaccination the first bloodsamples were collected.

    Pre-assignment
    Screening details
    		 798 patients were screened for participation and 773 were enrolled in the study.

    Period 1
    Period 1 title
    Administrive baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Arm title
    		 Administrative group for single arm study
    Arm description
    		 -
    Arm type
    		 Immune response after covid 19 vaccine

    Investigational medicinal product name
    Covid 19 vaccin in Sweden
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    1-2 doses with a couple of weeks apart, according to wich type of vaccin the participant received. Follow up doses were given according to national vaccin programme. The vaccines were given intramuscular.

    Number of subjects in period 1
    		Administrative group for single arm study
    Started
    773
    Completed
    773
    Period 2
    Period 2 title
    Overall trial
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded study

    Arms
    Arm title
    		 Study arm
    Arm description
    		 -
    Arm type
    		 Immune response after covid 19 vaccine

    Investigational medicinal product name
    Covid 19 vaccin in Sweden
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    1-2 doses with a couple of weeks apart, according to wich type of vaccin the participant received. Follow up doses were given according to national vaccin programme. The vaccines were given intramuscular.

    Number of subjects in period 2
    		Study arm
    Started
    773
    Completed
    547
    Not completed
    226
         Adverse event, non-fatal
    9
         Patient did not come to study follow up
    160
         Patients wish
    57

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Administrive baseline
    Reporting group description
    		 -

    Reporting group values
    		 Administrive baseline Total
    Number of subjects
    		 773 773
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 603 603
        From 65-84 years
    		 138 138
        85 years and over
    		 32 32
    Gender categorical
    Units: Subjects
        Female
    		 516 516
        Male
    		 257 257

    End points

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    End points reporting groups
    Reporting group title
    Administrative group for single arm study
    Reporting group description
    		 -
    Reporting group title
    Study arm
    Reporting group description
    		 -

    Primary: levels of specific antibodies against the SARS Covid 19 protein

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    End point title
    		 levels of specific antibodies against the SARS Covid 19 protein
    End point description
    Due to tecnical complications we were forced to create two comparison groups and therefor the total number of trial subject are incorrect (1546). The total number of subjects included in the trial are 773.
    End point type
    Primary
    End point timeframe
    From first dose of Covid 19 vaccine and up to 4 years.
    End point values
    		 Administrative group for single arm study Study arm
    Number of subjects analysed
    773
    773
    Units: units
        number (not applicable)
    773
    773
    Statistical analysis title
    		 Descriptive statistics
    Statistical analysis description
    A detailed descriptive analysis will be carried out where deciles of variable of antibody levels are presented, stratified by individuals previously infected/not previously infected infected with SARS-CoV. The primary question will be analyzed with Mann-Whitney U test.
    Comparison groups
    Administrative group for single arm study v Study arm
    Number of subjects included in analysis
    1546
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 0%
    Notes
    [1] - Each participant is it´s own control.

    Secondary: Cellular immune response

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    End point title
    		 Cellular immune response
    End point description
    The percentage of memory B cells specific to SARS-CoV-2 were analyzed in relation to vaccine type Due to tecnical complications we were forced to create two comparison groups and therefor the total number of trial subject are incorrect (1546). The total number of subjects included in the trial are 773.
    End point type
    Secondary
    End point timeframe
    From the first dose of Covid 19 vaccin and up to 4 years
    End point values
    		 Administrative group for single arm study Study arm
    Number of subjects analysed
    773
    773
    Units: units
        number (not applicable)
    773
    773
    Statistical analysis title
    		 Descriptive statistics
    Statistical analysis description
    Comparisons within groups for antibody levels in relation to vaccine doses were done by Wilcoxon matched-pairs signed rank test. Comparisons between groups that received different vaccines against Covid-19 were analyzed by Mann-Whitney’s test.
    Comparison groups
    Administrative group for single arm study v Study arm
    Number of subjects included in analysis
    1546
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From first Covid 19 dose given and up to 3 months after vaccination.
    Adverse event reporting additional description
    This was done after all follow up doses.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Not specified
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Overall study particiants
    Reporting group description
    		 If the person has been hospitalized or had another serious event, this will be assessed and in cases where the event can be considered a SUSAR this will be followed up with the help of medical records from the specific situation. All vaccinations in the study were given according to clinical routine in ordinary care and were not part of the study protocol. Therefor the only adverse events handled by the study was adverse events assessed as SUSARs. All SUSARs were reported to the authorities.

    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: All vaccinations in the study were given according to clinical routine in ordinary care and were not part of the study protocol. Therefor the only adverse events handled by the study was adverse events assessed as SUSARs. All SUSARs were reported to the authorities
    Serious adverse events
    		 Overall study particiants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    33 / 773 (4.27%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Testis cancer
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Syncope
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    allergic reaction
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Mental fatigue
         subjects affected / exposed
    2 / 773 (0.26%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    2 / 773 (0.26%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    chest pain
         subjects affected / exposed
    2 / 773 (0.26%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Palpitations
         subjects affected / exposed
    2 / 773 (0.26%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Broken heart syndrom
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 773 (0.26%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Numbness
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebellar stroke
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stroke
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Benign paroxysmal positional vertigo
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    2 / 773 (0.26%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 773 (0.26%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Colitis microscopic
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis area severity index increased
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Tooth infection
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 773 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall study particiants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 773 (0.00%)

    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/34260850
    http://www.ncbi.nlm.nih.gov/pubmed/38716734
    http://www.ncbi.nlm.nih.gov/pubmed/37575257
    For support, Contact us.
    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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