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    Summary
    EudraCT Number:2022-000035-23
    Sponsor's Protocol Code Number:VLA2001-307
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-02-05
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-000035-23
    A.3Full title of the trial
    OPEN-LABEL PHASE 2/3 CLINICAL STUDY TO INVESTIGATE SAFETY AND
    IMMUNOGENICITY OF A SINGLE VLA2001 BOOSTER VACCINATION IN ADULT VOLUNTEERS, AFTER RECEIPT OF NATIONALLY ROLLED OUT MRNA COVID-19 VACCINES AND/ OR NATURAL SARS-COV-2 INFECTION.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immune response of VLA2001 Booster vaccine in adults who received mRNA COVID-19 vaccines, have been SARS-CoV-2 naturally infected or had a combination of both
    A.3.2Name or abbreviated title of the trial where available
    VLA2001 booster after priming with mRNA COVID-19 vaccine and/or natural SARS-CoV-2 infection
    A.4.1Sponsor's protocol code numberVLA2001-307
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorValneva Austria GmbH
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportValneva Austria GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationValneva Austria GmbH
    B.5.2Functional name of contact pointValneva Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressCampus Vienna Biocenter 3
    B.5.3.2Town/ cityVienna
    B.5.3.3Post codeA-1030
    B.5.3.4CountryAustria
    B.5.4Telephone number0043120620
    B.5.6E-mailinfo@valneva.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVLA2001
    D.3.2Product code VLA2001
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSARS-CoV-2 virus, beta-propiolactone inactivated
    D.3.9.2Current sponsor codeVLA2001
    D.3.9.3Other descriptive nameSARS-CoV-2 virus, beta-propiolactone inactivated
    D.3.9.4EV Substance CodeSUB219103
    D.3.10 Strength
    D.3.10.1Concentration unit AgU antigen unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number33 or 66
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCpG-1018
    D.3.9.2Current sponsor codeCpG
    D.3.9.3Other descriptive nameCpG 1018
    D.3.9.4EV Substance CodeSUB219104
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0 or 2.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAlum
    D.3.9.2Current sponsor codeAlum
    D.3.9.3Other descriptive nameALUMINIUM HYDROXIDE
    D.3.9.4EV Substance CodeSUB33625
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5 or 1.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus.
    Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.
    E.1.1.1Medical condition in easily understood language
    COVID-19 is an illness caused by a new coronavirus that can spread from person to person. COVID-19 symptoms can range from mild (or no symptoms) to severe illness
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10084458
    E.1.2Term COVID-19 prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Immunogenicity:
    1) To determine the immune response in terms of GMT fold-rise for neutralising antibodies against SARS-CoV-2 following a single booster dose with VLA2001
    Safety:
    2) To assess tolerability of a VLA2001 booster vaccination
    E.2.2Secondary objectives of the trial
    Immunogenicity:
    1) To determine the immune response in terms of GMT for SARS-CoV-2-specific neutralizing antibodies following a single booster dose with VLA2001
    2) To determine the immune response in terms of GMT for IgG antibodies to SARS-CoV-2 S-protein following a single booster dose with VLA2001
    3) To determine the immune response in terms of GMT fold-rise for IgG antibodies to SARS-CoV-2 S-protein following a single booster dose with VLA2001
    4) To evaluate cellular immune responses following administration of VLA2001
    Safety:
    5) To describe the safety of VLA2001 following a single booster dose with VLA2001
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants must meet all inclusion criteria to be eligible for the study.
    ALL PARTICIPANTS:
    1. Participants of either gender aged 18 years and older at screening
    2. Participants must have read, understood, and signed the informed consent form (ICF)
    3. Medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol-specified follow-up.
    4. Participant has a Body Mass Index (BMI) of 18.0-30.0 kg/m2, inclusive, at screening (Visit 0).
    5. Must be able to attend all visits of the study and comply with all study procedures, including daily completion of the e-diary for 7 days following each vaccination.
    6. Women of childbearing potential (WOCBP), who are sexually active with a man, must be able and willing to use at least 1 highly effective method of contraception (i.e. implant contraceptive, intra-uterine device (IUD) containing either copper or levonorgestrel, male sterilization [vasectomy], female sterilization, injectable contraceptive, oral contraceptive pill, vaginal contraceptive ring, barrier type of birth control measure) from study start until a minimum of 3 months after receiving the booster vaccine.
    7. WOCBPs must have a negative pregnancy test prior to the booster vaccination.

    Cohort Specifics:
    Cohort 1A (>/= 18 years): 2 doses of mRNA, no infection
    Cohort 1B (18-50 years): 3 doses of mRNA, no infection
    Cohort 1C (18-50 years): 2 doses of mRNA, PCR or antigen confirmed SARS-CoV-2 infection
    Cohort 1D (18-50 years): 3 doses of mRNA, PCR or antigen confirmed SARS-CoV-2 infection
    Cohort 2A (> 50 years): 2 doses of mRNA, no infection
    Cohort 2B (> 50 years): 3 doses of mRNA, no infection
    Cohort 2C (> 50 years): 2 doses of mRNA, PCR or antigen confirmed SARS-CoV-2 infection
    Cohort 2D (> 50 years): 3 doses of mRNA, PCR or antigen confirmed SARS-CoV-2 infection
    Cohort 3 (>/= 18 years): PCR or antigen confirmed SARS-CoV-2 infection, but not vaccinated

    Note: Rapid antigen test results can be considered as proof of previous Covid-19 infection but only if the antigen test results have been officially documented or registered in an official system - as for the PCR test results, in all cases, a paper document must be available/printable to be considered sufficient proof of a previous infection prior to enrollment (in the relevant Cohorts).
    E.4Principal exclusion criteria
    Participants will not be eligible for the study if they meet any of the exclusion criteria.
    1. Participant is pregnant or planning to become pregnant within 3 months after booster administration
    2. History of allergy to any component of the vaccine
    3. Participant had close contact to persons with confirmed SARS-CoV-2 infection within 30 days prior to screening (Visit 0)
    4. Participant has participated in a clinical study involving an investigational SARS-CoV-2 vaccine or has received or plans to receive a licensed SARS-CoV-2 vaccine during the duration of the study
    5. Significant infection or other acute illness, including fever > 37.8°C within 48 hours before vaccination
    6. Positive SARS-CoV-2 rapid Antigen test result during screening (Visit 0) or Visit 1
    7. Participant has a known or suspected defect of the immune system, such as participants with congenital or acquired immunodeficiency, including infection with HIV, status post organ transplantation or immuno-suppressive therapy within 4 weeks prior to the expected day of vaccination (Visit 1).
    8. Participant has a history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than 5 years ago that is considered to have achieved a cure, the participant may be enrolled. A history of hematologic malignancy is a permanent exclusion. Participants with a history of skin cancer must not be vaccinated at the previous tumour site
    9. History of drug dependency or current use of drug of abuse or alcohol abuse at screening
    10. Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to the expected day of first vaccination (Visit 1)
    11. History of clinically significant bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
    12. Severe and uncontrolled ongoing autoimmune or inflammatory disease, History of Guillain-Barre syndrome or any other demyelinating condition
    13. Any other significant disease, disorder or finding which in the opinion of the investigator may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study
    Prior/concomitant therapy:
    14. Receipt of immunoglobulin or another blood product within the 3 months before expected day of vaccination (Visit 1) in this study or those who expect to receive immunoglobulin or another blood product during this study
    15. Receipt of medications to treat or prevent COVID-19 (except licensed mRNA vaccine for participants of Cohort 1 and 2)
    16. Receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine or for medical emergencies such as tetanus or rabies exposure, within 28 days prior to the expected day of first vaccination (Visit 1)

    Others:
    17. Any member of the study team or sponsor
    18. An immediate family member or household member of the study’s personnel
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity:
    1) GMT fold-rise for neutralising antibodies against SARS-CoV-2 at Day 15 following a single booster dose with VLA2001
    Safety:
    2) Frequency and severity of solicited AEs (local and systemic reactions) within 7 days after the VLA2001 booster vaccination
    E.5.1.1Timepoint(s) of evaluation of this end point
    Immunogenicity:
    1) Day 15 for neutralising antibodies
    Safety:
    2) within 7 days for solicited AEs
    E.5.2Secondary end point(s)
    Immunogenicity:
    1) Immune response as determined by the GMT of SARS-CoV-2-specific neutralizing antibodies at Visit 1 (pre-booster, Day 1) and Visit 2 (Day 15).
    2) Proportion of participants achieving an at least 2-, 4-, 10- or 20-fold rise over baseline (pre-booster) in terms of neutralizing antibodies to SARS-CoV-2 S-protein at Visit 2 (Day 15).
    3) GMT fold-rise of IgG antibodies to the SARS-CoV-2 S-protein at Day 15.
    4) Immune response as determined by the GMT of IgG antibodies to the SARS-CoV-2 S-protein at Visit 1 (pre-booster, Day 1) and Visit 2 (Day 15).
    5) Proportion of participants achieving an at least 2-, 4-, 10- or 20-fold rise over baseline (pre-booster) in terms of IgG antibodies to SARS-CoV-2 S-protein at Visit 2 (Day 15).
    6) Assessment of T-cell responses from PBMCs after in vitro stimulation with SARS-CoV-2 antigens using e.g., ELISpot (IFN) or intracellular cytokine staining (IL-2, IL-4, IL-5, IL-13, TNF, IFN) at Day 1 and Day 15.
    Safety:
    7) Frequency and severity of any AE up to 4 weeks after vaccination
    8) Frequency and severity of unsolicited AEs up to 4 weeks after vaccination
    9) Frequency and severity of any unsolicited vaccine-related AE up to 4 weeks after vaccination
    10) Frequency and severity of any serious adverse event (SAE) up to 4 weeks after vaccination and up to Day 180.
    11) Frequency and severity of any adverse event of special interest (AESI) up to 4 weeks after vaccination and up to Day 180.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity:
    1) Day 1 and Day 15 for neutralizing antibodies
    2) Day 15 for neutralizing antibodies
    3) Day 15 for IgG antibodies
    4) Day 1 and Day 15 for IgG antibodies
    5) Day 15 for IgG antibodies
    6) Day 1 and Day 15 for T-cell responses
    Safety:
    7) up to 4 weeks after vaccination for any AE
    8) up to 4 weeks after vaccination for unsolicited AEs
    9) up to 4 weeks after vaccination for any unsolicited vaccine-related AE
    10) up to 4 weeks after vaccination and up to Day 180 for any SAE
    11) up to 4 weeks after vaccination and up to Day 180 for any AESI
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    New Zealand
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 164
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 178
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    There will be no need for continued treatment once the study is completed as participants would have received the complete vaccination schedule during the study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-11
    P. End of Trial
    P.End of Trial StatusOngoing
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