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A Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy Adults

Sponsor
Janssen Vaccines & Prevention B.V. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04908722
Collaborator
(none)
1,590
Enrollment
55
Locations
6
Arms
30.3
Anticipated Duration (Months)
28.9
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate non-inferiority (NI) in terms of humoral immune responses after 6 dose levels of Ad26.COV2.S.

Condition or Disease Intervention/Treatment Phase
  • Biological: Ad26.COV2.S
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1590 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A Randomized, Double-blind, Phase 3 Study to Evaluate 6 Dose Levels of Ad26.COV2.S Administered As a Two-Dose Schedule in Healthy Adults
Actual Study Start Date :
Jun 18, 2021
Anticipated Primary Completion Date :
Sep 28, 2023
Anticipated Study Completion Date :
Dec 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1: Ad26.COV2.S Dose Level 1

Participants in the main study and sub study will receive intramuscular (IM) injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 1 on Days 1 and 57.

Biological: Ad26.COV2.S
Participants will receive intramuscular (IM) injections of Ad26.COV2.S.
Other Names:
  • JNJ-78436735
  • Ad26COVS1
  • VAC31518

    		•
    Experimental: Group 2: Ad26.COV2.S Dose Level 2

    Participants will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 2 on Days 1 and 57 in the main study.

    Biological: Ad26.COV2.S
    Participants will receive intramuscular (IM) injections of Ad26.COV2.S.
    Other Names:
  • JNJ-78436735
  • Ad26COVS1
  • VAC31518

    		•
    Experimental: Group 3: Ad26.COV2.S Dose Level 3

    Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 3 on Days 1 and 57.

    Biological: Ad26.COV2.S
    Participants will receive intramuscular (IM) injections of Ad26.COV2.S.
    Other Names:
  • JNJ-78436735
  • Ad26COVS1
  • VAC31518

    		•
    Experimental: Group 4: Ad26.COV2.S Dose Level 4

    Participants will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 4 on Days 1 and 57 in the main study.

    Biological: Ad26.COV2.S
    Participants will receive intramuscular (IM) injections of Ad26.COV2.S.
    Other Names:
  • JNJ-78436735
  • Ad26COVS1
  • VAC31518

    		•
    Experimental: Group 5: Ad26.COV2.S Dose Level 5

    Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 5 on Days 1 and 57.

    Biological: Ad26.COV2.S
    Participants will receive intramuscular (IM) injections of Ad26.COV2.S.
    Other Names:
  • JNJ-78436735
  • Ad26COVS1
  • VAC31518

    		•
    Experimental: Group 6: Ad26.COV2.S Dose Level 6

    Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 6 on Days 1 and 57.

    Biological: Ad26.COV2.S
    Participants will receive intramuscular (IM) injections of Ad26.COV2.S.
    Other Names:
  • JNJ-78436735
  • Ad26COVS1
  • VAC31518

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Main Study: Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Concentration Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination [28 days after first vaccination (Day 29)]

      SARS-CoV-2 S protein binding antibodies concentration measured by ELISA will be reported.

    2. Main Study: ELISA Geometric Mean Concentrations (GMCs) 28 Days After First Vaccination [28 days after first vaccination (Day 29)]

      Non-inferiority (NI) will be assessed in terms of humoral immune response expressed by the GMCs of S-ELISA.

    3. Main Study: SARS-CoV-2 S Protein Binding Antibodies Concentration Measured by ELISA 14 Days After Second Vaccination [14 days after second vaccination (Day 71)]

      SARS-CoV-2 S protein binding antibodies concentration measured by ELISA will be reported.

    4. Main Study: ELISA GMCs 14 Days After Second Vaccination [14 days after second vaccination (Day 71)]

      NI will be assessed in terms of humoral immune response expressed by the GMCs of S-ELISA.

    Secondary Outcome Measures

    1. Main and Sub Study: Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA [Up to 60 weeks]

      Serological response to vaccination to SARS-COV-2 S protein as measured by ELISA will be reported.

    2. Main and Sub Study: SARS-CoV-2 S Protein Binding Antibody GMCs as Measured by ELISA or Equivalent Assay [Up to 60 weeks]

      SARS-CoV-2 S protein binding antibody GMCs as measured by ELISA or equivalent assay will be reported.

    3. Main and Sub Study: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination [7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 57 (up to Day 64)]

      Solicited local AEs include injection site pain/tenderness, erythema and swelling at the study vaccine injection site and the extent (largest diameter) of any erythema and swelling (using the ruler supplied) will be noted in the participant diary after 7 days after each vaccination.

    4. Main and Sub Study: Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination [7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 57 (up to Day 64)]

      Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary after 7 days of each vaccination.

    5. Main and Sub Study: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination [28 days after first vaccination on Day 1 (up to Day 29); 28 days after second vaccination on Day 57 (up to Day 85)]

      Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.

    6. Main and Sub Study: Number of Participants with Serious Adverse Events (SAEs) [Up to 60 weeks]

      SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

    7. Main and Sub Study: Number of Participants with Adverse Events of Special Interest (AESIs) [Up to 60 weeks]

      Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.

    8. Main and Sub Study: Number of Participants with Medically-Attended Adverse Events (MAAEs) [6 months after second vaccination (up to 32 weeks)]

      MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.

    9. Main Study: Number of Participants with AEs Leading to Study Discontinuation [Up to 60 weeks]

      Number of participants with AEs leading to study discontinuation will be reported.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study

    • Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening. 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 Coronavirus disease 2019 (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

    • All female 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

    • 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

    • Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study

    Exclusion Criteria:

    • Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (C) (100.4 degree Fahrenheit [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

    • 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)

    • Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccinations; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of the first or subsequent study vaccinations

    • Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study

    • Participant previously received a coronavirus vaccine

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baptist Health Center for Clinical Research Little Rock Arkansas United States 72205
    2 Anaheim Clinical Trials, LLC Anaheim California United States 92801
    3 Ark Clinical Research Long Beach California United States 90806
    4 Paradigm Clinical Research Centers, Inc. Redding California United States 96001
    5 California Research Foundation San Diego California United States 92103-6204
    6 Wr-McCr, Llc San Diego California United States 92120
    7 Ark Clinical Research Tustin California United States 92780
    8 Velocity Clinical Research, Hallandale Beach Hallandale Beach Florida United States 33009
    9 Health Awareness inc. Jupiter Florida United States 33458
    10 Accel Research Sites Maitland Florida United States 32751
    11 Floridian Research Institute Miami Florida United States 33179
    12 Medpharmics, LLC Metairie Louisiana United States 70006
    13 Synexus Clinical Research US, Inc Saint Louis Missouri United States 63141
    14 Clinical Research Center of Nevada Las Vegas Nevada United States 89106
    15 Rochester Clinical Research, Inc Rochester New York United States 14609
    16 Wake Research Associates Raleigh North Carolina United States 27612
    17 Trial Management Associates, LLC Wilmington North Carolina United States 28403
    18 Tekton Research Inc. Yukon Oklahoma United States 73099
    19 Coastal Carolina Research Center North Charleston South Carolina United States 29405
    20 Ventavia Research Group, LLC Keller Texas United States 76248
    21 Research Your Health Plano Texas United States 75093
    22 Clinical Research Partners, LLC Richmond Virginia United States 23226
    23 Hospital de Clinicas da Universidade Federal De Minas Geraisnas Gerais Belo Horizonte Brazil 30130-100
    24 Santa Casa de Misericordia de Belo Horizonte Belo Horizonte Brazil 30150-221
    25 CECOR - Centro Oncológico de Roraima Boa Vista Brazil 69304-415
    26 HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas Campinas Brazil 13060-904
    27 Núcleo de Medicina Tropical - Universidade Federal do Ceará Ceará Brazil 60430-160
    28 Hospital São José Criciúma Brazil 88801-250
    29 Centro de Estudos e Pesquisas em Moléstias Infecciosas Natal Brazil 59025-050
    30 Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo Ribeirao Preto Brazil 14048-900
    31 Hospital Geral de Nova Iguacu - HGNI DST/AIDS Rio De Janeiro Brazil 26030-380
    32 Centro de Referencia E Treinamento Dst/Aids Sao Paulo Brazil 02141-000
    33 CPQuali Pesquisa Clinica LTDA ME São Paulo Brazil 01228-000
    34 Klinische Forschung Berlin-Mitte GmbH Berlin Germany 10787
    35 Clinical Research HamburggmbH Hamburg Germany 22143
    36 Klinische Forschung Hannover-Mitte GmbH Hannover Germany 30159
    37 Synexus Clinical Research GmbH Leipzig Germany 04103
    38 Universitaetsmedizin Rostock Rostock Germany 18057
    39 Centrum Medyczne PRATIA Bydgoszcz Bydgoszcz Poland 85-796
    40 Uniwersyteckie Centrum Kliniczne, Osrodek Badan Klinicznych Wczesnych Faz Gdansk Poland 80-214
    41 Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska Gdansk Poland 80-462
    42 Gdanskie Centrum Zdrowia Gdansk Poland 80-542
    43 Centrum Medyczne Medyk Rzeszow Poland 35-055
    44 Centrum Medyczne Pratia Poznan Skorzewo Poland 60-185
    45 Nasz Lekarz, Nzoz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodn Torun Poland 87-100
    46 Szpital im. Swietej Jadwigi Slaskiej, Oddział Pediatryczny z Pododdziałem Niemowlęcym Trzebnica Poland 55-100
    47 SP ZOZ Wroclawskie Centrum Zdrowia Wroclaw Poland 50-136
    48 Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy Wroclaw Poland 51-162
    49 Synexus Helderberg Clinical Research Centre Cape Town South Africa 7130
    50 Ndlovu Elandsdoorn Site Dennilton South Africa 0485
    51 Centre for the AIDS Programme of Research in South Africa KwaZulu-Natal South Africa 4110
    52 Stanza Clinical Research Centre : Mamelodi Mamelodi East South Africa 122
    53 PHOENIX PHARMA (Pty) Ltd Port Elizabeth South Africa 6001
    54 Gct Sunnyside Pretoria South Africa 0002
    55 Setshaba Research Centre Soshanguve South Africa 152

    Sponsors and Collaborators

    • Janssen Vaccines & Prevention B.V.

    Investigators

    • Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial, Janssen Vaccines & Prevention B.V.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Vaccines & Prevention B.V.
    ClinicalTrials.gov Identifier:
    NCT04908722
    Other Study ID Numbers:
    • CR108960
    • 2020-005801-14
    • VAC31518COV3003
    First Posted:
    Jun 1, 2021
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes

    Study Results

    No Results Posted as of Aug 3, 2022