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    Summary
    EudraCT Number:2020-002584-63
    Sponsor's Protocol Code Number:VAC31518COV2001
    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:2020-09-15
    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 number2020-002584-63
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older
    A.4.1Sponsor's protocol code numberVAC31518COV2001
    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 SponsorJanssen Vaccines & Prevention B.V.
    B.1.3.4CountryNetherlands
    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 supportJanssen Vaccines & Prevention B.V.
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportBiomedical Advanced Research and Development Authority (BARDA)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Research & Development
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 20
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameAd26.COV2.S (also known as Ad26COVS1)
    D.3.2Product code VAC31518
    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 INNNot available
    D.3.9.2Current sponsor codeVAC31518
    D.3.9.3Other descriptive nameAd26.COV2.S (also known as Ad26COVS1)
    D.3.9.4EV Substance CodeSUB208328
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms/ml billion organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    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 nameAd26.COV2.S (also known as Ad26COVS1)
    D.3.2Product code VAC31518
    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 INNNot available
    D.3.9.2Current sponsor codeVAC31518
    D.3.9.3Other descriptive nameAd26.COV2.S (also known as Ad26COVS1)
    D.3.9.4EV Substance CodeSUB208328
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms/ml billion organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy Volunteers (Prevention of COVID-19)
    E.1.1.1Medical condition in easily understood language
    Healthy Volunteers (Prevention of COVID-19)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess the humoral immune response to 3 dose levels (5x10^10 virus particle (vp), 2.5x10^10 vp, 1.25x10^10 vp) of Ad26.COV2.S, administered intramuscularly (IM) as a 2-dose schedule at a 56-day interval, 28 days after Vaccination 2.
    2. To assess the humoral immune response to 2 dose levels (1 x10^11 vp and 5x10^10 vp) of Ad26.COV2.S, administered IM as a single vaccination, 28 days after Vaccination 1.
    3. To assess the humoral immune response to Ad26.COV2.S at the 5x10^10 vp dose level, administered IM as a 2-dose schedule at a 28-day and at an 84-day interval, 28 days after Vaccination 2.
    4. To assess the safety and reactogenicity of Ad26.COV2.S, administered IM at several dose levels, as a 2-dose or a single-dose schedule.
    E.2.2Secondary objectives of the trial
    1. To assess the anamnestic response to antigen presentation of Ad26.COV2.S at the 1.25x10^10 vp dose level, administered 4 months after Vaccination 2 (2-dose schedule) or 6 months after a Vaccination 1 (single-dose schedule), 7 days after antigen presentation.
    2. To assess the safety and reactogenicity of antigen presentation of Ad26.COV2.S at the 1.25x10^10 vp dose level, administered 4 months after Vaccination 2 (2-dose schedule) or 6 months after a Vaccination 1 (single-dose schedule).
    3. To assess the humoral immune response to Ad26.COV2.S across all groups, at all blood collection timepoints.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant is 18 to 55 years of age, inclusive, or 65 years of age or older on the day of signing the ICF.
    2. Participant must have a body mass index (BMI) <30.0 kg/m2.
    3. Participant 18 to 55 years of age, inclusive: Participant must be healthy, in the investigator’s clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe COVID-19, except for smoking, which is allowed.
    Participant 65 years of age and older: in the investigator’s clinical judgment, participant must be either in good or stable health. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe COVID-19, except for smoking, which is allowed. If on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participant will be included on the basis of physical examination, medical history, and vital signs.
    4. All participants of childbearing potential must:
    a. Have a negative highly sensitive urine pregnancy test at screening.
    b. Have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration.
    5. Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine.
    E.4Principal exclusion criteria
    1. Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC (100.4°F) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor.
    2. Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence).
    3. Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine).
    4. Participant has abnormal function of the immune system.
    5. Participant has a history of any neurological disorders or seizures including Guillain-Barré syndrome, with the exception of febrile seizures during childhood.
    6. Participant has a history of chronic urticaria (recurrent hives), eczema or adult atopic dermatitis.
    7. Participant received treatment with immunoglobulins in the 3 months or blood products in the 4 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study.
    8. Participant is a woman who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study vaccine.
    9. Participant has chronic active hepatitis B or hepatitis C infection per medical history.
    10. Participant previously received a coronavirus vaccine.
    11. Participant has a positive diagnostic test result for past (serological testing) or current (PCR based viral RNA detection) SARS-CoV-2 infection at screening.
    12. Participants with comorbidities that are or might be associated with an increased risk of progression to severe COVID-19, ie, participants with moderate-to severe asthma; chronic lung diseases such as chronic obstructive pulmonary disease (COPD) (including emphysema and chronic bronchitis), idiopathic pulmonary fibrosis and cystic fibrosis; diabetes (including type 1, type 2, or gestational); serious heart conditions, including heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and pulmonary hypertension or high blood pressure; obesity (BMI ≥ 30 kg/m2); chronic liver disease, including cirrhosis; sickle cell disease; thalassemia; cerebrovascular disease; neurologic conditions (dementia); and participants who live in nursing homes or long-term care facilities. This list is consistent with the list of conditions that increase the risk of progression to severe COVID-19 available at the CDC website at the time of writing of this protocol, except for smoking, which is allowed.
    13. Participant who is currently working in an occupation with a high risk of exposure to SARS-CoV-2 infection (eg, health care worker or emergency response personnel who work in close contact with SARS-CoV-2 infected patients) or considered at the investigator’s discretion to be at increased risk to acquire COVID-19 for any other reason.
    14. Participant who has had a known exposure to an individual with confirmed COVID-19 or SARS-CoV-2 infection within the past 2 weeks.
    15. History of confirmed SARS or MERS.
    E.5 End points
    E.5.1Primary end point(s)
    1a. Serological response to vaccination as measured by virus neutralization assay (VNA) titers and enzyme-linked immunosorbent assay (S-ELISA, ELISA Units/mL [EU/mL]), 28 days after Vaccination 2.
    1b. Antibody geometric mean titers (GMTs) (VNA) and geometric mean concentrations (GMCs) (S-ELISA), 28 days after Vaccination 2.
    2a. Serological response to vaccination as measured by VNA titers and ELISA (S-ELISA, EU/mL), 28 days after Vaccination 1.
    2b. Antibody GMTs (VNA) and GMCs (S-ELISA), 28 days after Vaccination 1.
    3a. Serological response to vaccination as measured by VNA titers and ELISA (S-ELISA, EU/mL), 28 days after Vaccination 2.
    3b. Antibody GMTs (VNA) and GMCs (S-ELISA), 28 days after Vaccination 2.
    4a. Solicited local and systemic adverse events (AEs) for 7 days after each vaccination.
    4b. Unsolicited AEs for 28 days after each vaccination.
    4c. Serious adverse events (SAEs) throughout the study (from first vaccination until end of the study).
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 or 28 days after each vaccination
    Safety endpoints - continuous throughout the study
    E.5.2Secondary end point(s)
    1a. Serological response to vaccination as measured by VNA titers and ELISA (S-ELISA, EU/mL), 7 days after antigen presentation.
    1b. Antibody GMTs (VNA) and GMCs (S-ELISA), 7 days after antigen presentation.
    2a. Solicited local and systemic AEs for 7 days after antigen presentation.
    2b. Unsolicited AEs for 28 days after antigen presentation.
    2c. SAEs throughout the study (from antigen presentation until end of the study).
    3a. Neutralizing antibody titers to the wild-type SARS-CoV-2 virus and/or pseudovirion expressing S protein as measured by VNA, at all blood collection timepoints.
    3b. Binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins (eg, S protein) as measured by ELISA, at all blood collection timepoints.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 7 or 28 days after antigen presentation
    - at all blood collection timepoints
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Reactogenicity and Immunogenicity
    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial10
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 367
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 183
    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 state135
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 550
    F.4.2.2In the whole clinical trial 550
    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)
    None
    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 Decision2020-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-26
    P. End of Trial
    P.End of Trial StatusOngoing
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