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    Clinical Trial Results:
    P-pVAC-SARS-CoV-2: Phase I single-center safety and immungenicity trial of multi-peptide vaccination to prevent COVID-19 infection in adults

    Summary
    EudraCT number
    		 2020-002502-75
    Trial protocol
    		 DE  
    Global end of trial date
    21 Sep 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P-pVAC-SARS-CoV-2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital Tuebingen
    Sponsor organisation address
    Otfried-Mueller-Strasse 10, Tuebingen, Germany, 72076
    Public contact
    Zentrum für Klinische Studien, University Hospital Tuebingen, 49 70712985638, zks-pm@med.uni-tuebingen.de
    Scientific contact
    Zentrum für Klinische Studien, University Hospital Tuebingen, 49 70712985638, zks-pm@med.uni-tuebingen.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
    21 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Sep 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Sep 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and immunogenicity of a single use of a SARS-CoV-2 specific multi-peptide vaccine in combination with the TLR1/2 ligand XS15 in adults The primary objective of this trial is to evaluate the safety and tolerability of the CoVac-1 vaccine, a single dose SARS-CoV-2 specific multi-peptide vaccine combined with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG in adults.
    Protection of trial subjects
    The procedures set out in this trial protocol, pertaining to the conduct, evaluation, and documentation of this trial, are designed to ensure that all persons involved in the trial act according to Good Clinical Practice (GCP) and the ethical principles described in the applicable version of the Declaration of Helsinki. Each volunteer will be informed about the modalities of the clinical study in accordance with the provided volunteer informed consent (IC). The volunteer is to be informed both in writing and verbally by the investigator before any study-specific procedure is performed. The volunteer must be given sufficient time to decide whether to participate in this comparative study and to ask questions concerning this trial. It must also be made clear to the volunteer that he / she can withdraw from the study at any time without giving reasons and that he / she will not be in any way disadvantaged for this. The subject must give consent in writing. The volunteer and informing physician must each personally date and sign the informed consent form with an integrated declaration on data privacy protection, whereby the physician must not sign before the volunteer. Original signed documents will be part of the investigator’s file and retained with it. A copy of the signed informed consent document and study insurance policy must be given to the subject. The documents must be in a language understandable to the subject and must specify who informed the subject. The subjects will be informed as soon as possible if new information may influence his/her decision to participate in the trial. The communication of this information should be documented in the volunteer chart. Each volunteer is insured against any health impairment occurring as a result of participation in the study in accordance with the laws and regulations of the “German Arzneimittelgesetz”. Travel insurance will be included for all volunteers enrolled in the clinical trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Nov 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    12
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From November 28th 2020 to January 15th 2021, 12 healthy adults were enrolled in part I (age group 18–55 years). From March 24th 2021 to April 1st 2021, 24 adults were enrolled in part II (age group 56–80 years). All the recruitment process was conducted in University Hospital Tuebingen (Germany).

    Pre-assignment
    Screening details
    		 The study population were healthy subjects (volunteers): Healthy adult women and men aged 18-55 (Part I), followed by adult women and men aged 56-80 with age adjusted health condition (Part II). The trial population consisted of both genders.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This clinical study is a phase I, single-center, non- randomized, single-arm, uncontrolled and open-label trial.

    Arms
    Arm title
    		 Investigational arm
    Arm description
    		 The trial is a single-arm design where all subjects received the CoVac-1 vaccine (investigational medicinal product).
    Arm type
    		 Experimental

    Investigational medicinal product name
    CoVac-1: Peptide cocktail emulsified in Montanide ISA 51 VG
    Investigational medicinal product code
    Other name
    CoVac-1
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single vaccination with the IMP CoVac-1 (SARS-CoV-2 HLA-DR peptides, XS15 emulsified in Montanide ISA 51 VG) (500 μl) will be applied subcutaneously (s.c.) to the abdominal skin.

    Number of subjects in period 1
    		Investigational arm
    Started
    36
    Completed
    36

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 36 36
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 12
        From 65-84 years
    		 24 24
    Age continuous
    From 24 March 2021 to 1 April 2021, 24 adults were enrolled in part II (age group 56–80 years). Of part I and part II participants, 33% and 50%, respectively, were female participants. The median participant age was 38 (range 23–50) and 62 (range 56–70) years for part I and part II, respectively.
    Units: years
        median (full range (min-max))
    		 50 (23 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    Investigational arm
    Reporting group description
    		 The trial is a single-arm design where all subjects received the CoVac-1 vaccine (investigational medicinal product).

    Primary: Safety and Tolerability

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    End point title
    		 Safety and Tolerability [1]
    End point description
    The primary endpoint was the nature, frequency, and severity of AEs and/or SAEs associated with administration of CoVac-1. Solicited: ADRs/AE occurring from the time of each injection throughout 28 days following the procedure, facilitated by use of a volunteer diary: -Unsolicited: AEs from the time of injection throughout 56 days following injection. -SAEs from the time of injection until the final study visit for each. -Incidence of AESIs until the final study visit for each subject.
    End point type
    Primary
    End point timeframe
    Until day 56 since the vaccine administration
    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: Statistical details and charts can be found in the scientific publication: https://www.nature.com/articles/s41586-021-04232-5#citeas https://pubmed.ncbi.nlm.nih.gov/34814158/
    End point values
    		 Investigational arm
    Number of subjects analysed
    36
    Units: Adverse Events
    36
    No statistical analyses for this end point

    Secondary: Imnunogenicity

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    End point title
    		 Imnunogenicity
    End point description
    T cell responses were assessed in all participants at baseline (day 1), on days 7, 14 and 28, as well as in the follow-up period on day 56 and month 3 after vaccination.
    End point type
    Secondary
    End point timeframe
    T cell responses were assessed in all participants at baseline (day 1), on days 7, 14 and 28, as well as in the follow-up period on day 56 and month 3 after vaccination.
    End point values
    		 Investigational arm
    Number of subjects analysed
    36
    Units: CD4+ and CD8+ T cell responses
    36
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Primary safety outcomes reflect the nature, frequency and severity of solicited adverse events until day 56 after vaccination.
    Adverse event reporting additional description
    The documentation was facilitated by use of a volunteer diary (for 28 days after vaccination) and graded by the investigators according to a modified Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grading scale
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    Investigational arm
    Reporting group description
    		 The trial is a single-arm design where all subjects received the CoVac-1 vaccine (investigational medicinal product).

    Serious adverse events
    		 Investigational arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 36 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Investigational arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 36 (100.00%)
    General disorders and administration site conditions
    Local granuloma
    Additional description: Local granuloma in the vaccination site
         subjects affected / exposed
    36 / 36 (100.00%)
         occurrences all number
    36

    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
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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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