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A Study of Ad26.COV2.S in Adults (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04436276
Recruitment Status : Active, not recruiting
First Posted : June 18, 2020
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Tracking Information
First Submitted Date  ICMJE June 15, 2020
First Posted Date  ICMJE June 18, 2020
Last Update Posted Date April 12, 2021
Actual Study Start Date  ICMJE July 15, 2020
Estimated Primary Completion Date December 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2020)
  • Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination [ Time Frame: Day 8 (7 Days after first vaccination on Day 1) ]
    Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after first vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
  • Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination [ Time Frame: Day 64 (7 Days after second vaccination on Day 57) ]
    Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after second vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
  • Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination [ Time Frame: Day 8 (7 Days after first vaccination on Day 1) ]
    Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after first vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
  • Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination [ Time Frame: Day 64 (7 Days after second vaccination on Day 57) ]
    Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after second vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
  • Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination [ Time Frame: Day 29 (28 Days after first vaccination on Day1) ]
    Number of participants with unsolicited AEs for 28 days after first vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.
  • Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination [ Time Frame: Day 85 (28 Days after second vaccination) ]
    Number of participants with unsolicited AEs for 28 days after second vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.
  • Cohort 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 1 Year after the Second Vaccination [ Time Frame: From Day 57 (vaccination 2) up to 1 year ]
    SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
  • Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination [ Time Frame: Day 1 (vaccination 1) up to 6 Months ]
    SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2020)
  • Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination [ Time Frame: Day 8 (7 Days after first vaccination on Day 1) ]
    Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after first vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
  • Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination [ Time Frame: Day 64 (7 Days after second vaccination on Day 57) ]
    Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after second vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
  • Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination [ Time Frame: Day 8 (7 Days after first vaccination on Day 1) ]
    Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after first vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
  • Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination [ Time Frame: Day 64 (7 Days after second vaccination on Day 57) ]
    Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after second vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
  • Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination [ Time Frame: Day 29 (28 Days after first vaccination on Day1) ]
    Number of participants with unsolicited AEs for 28 days after first vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.
  • Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination [ Time Frame: Day 85 (28 Days after second vaccination) ]
    Number of participants with unsolicited AEs for 28 days after second vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.
  • Cohort 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 1 Year after the First Vaccination [ Time Frame: From Day 1 (vaccination 1) up to 1 year ]
    SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
  • Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination [ Time Frame: Day 1 (vaccination 1) up to 6 Months ]
    SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2020)
  • Cohorts 1, 2, and 3: Number of Participants With SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) [ Time Frame: Up to 38 Months ]
    Number of participants with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported.
  • Cohorts 1, 2, and 3: Number of Participants with SARS-CoV-2 Binding Antibodies Assessed by ELISA [ Time Frame: Up to 38 Months ]
    Number of participants with SARS-CoV-2 binding antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response will be reported.
  • Cohorts 1, 2, and 3: Number of Participants with T-helper (Th)-1 and Th-2 Immune Responses as Assessed by Flow Cytometry [ Time Frame: Up to 38 Months ]
    Number of participants with Th-1 and Th-2 immune responses will be reported. Th1 and Th2 immune responses will be assessed by flow cytometry after SARS-CoV-2 S protein peptide stimulation of peripheral blood mononuclear cells (PBMCs) and intracellular staining [ICS] including cluster of differentiation (CD)-4+/CD-8+, Interferons (INF)-gamma, interleukin [IL] 2, Tumor Necrosis Factor (TNF)-alpha, IL-4, IL-5, IL-13, and/or other Th-1/Th-2 markers.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2020)
  • Cohorts 1, 2, and 3: Number of Participants With SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) [ Time Frame: Up to 32 Months ]
    Number of participants with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported.
  • Cohorts 1, 2, and 3: Number of Participants with SARS-CoV-2 Binding Antibodies Assessed by ELISA [ Time Frame: Up to 32 Months ]
    Number of participants with SARS-CoV-2 binding antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response will be reported.
  • Cohorts 1, 2, and 3: Number of Participants with T-helper (Th)-1 and Th-2 Immune Responses as Assessed by Flow Cytometry [ Time Frame: Up to 32 Months ]
    Number of participants with Th-1 and Th-2 immune responses will be reported. Th1 and Th2 immune responses will be assessed by flow cytometry after SARS-CoV-2 S protein peptide stimulation of peripheral blood mononuclear cells (PBMCs) and intracellular staining [ICS] including cluster of differentiation (CD)-4+/CD-8+, Interferons (INF)-gamma, interleukin [IL] 2, Tumor Necrosis Factor (TNF)-alpha, IL-4, IL-5, IL-13, and/or other Th-1/Th-2 markers.
  • Cohorts 1, 2, and 3: Number of Participants With Th-1 and Th-2 Immune Responses as Assessed by ELISpot [ Time Frame: Up to 32 Months ]
    Number of participants with Th-1 and Th-2 immune responses as assessed by enzyme-linked immunospot (ELISpot) will be reported. Th-1 and Th-2 will be assessed by dual or single IFN-gamma and IL-4 ELISpot assay after stimulation of peripheral blood mononuclear cell (PBMCs) with SARS-CoV-2 S protein peptides.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Ad26.COV2.S in Adults (COVID-19)
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26COVS1 in Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older
Brief Summary The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort, in healthy adults aged greater than or equal to 18 to less than or equal to 55 years and in adults aged greater than or equal to 65 years in good health with or without stable underlying conditions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: Ad26.COV2.S
    Participants will receive intramuscular (IM) injection of Ad26.COV2.S.
    Other Names:
    • JNJ-78436735
    • Ad26COVS1
  • Biological: Placebo
    Participants will receive Placebo.
Study Arms  ICMJE
  • Experimental: Cohort 1a
    Participants (healthy adults aged greater than or equal to (>=)18 to less than or equal to (<=) 55 years) will receive Ad26.COV2.S at 2 dose levels, as a single dose or 2 dose schedule with an 8-week interval or matching Placebo on Day 1 and Day 57. At unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S. If they choose not to receive Ad26.COV2.S they will be asked to continue to be followed in this study.
    Interventions:
    • Biological: Ad26.COV2.S
    • Biological: Placebo
  • Experimental: Cohort 1b
    Participants (healthy adults aged >=18 to <= 55 years) will receive Ad26.COV2.S as a single vaccination in the primary regimen or matching Placebo on Day 1 and Day 57. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S. If they choose not to receive Ad26.COV2.S they will be asked to continue to be followed in this study.
    Interventions:
    • Biological: Ad26.COV2.S
    • Biological: Placebo
  • Experimental: Cohort 2a
    Participants (healthy adults aged >=18 to <=55 years) will receive Ad26.COV2.S as a single vaccination in the primary regimen or matching Placebo on Day 1, followed by booster vaccination at 6, 12 or 24 months with same dose or matching Placebo. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S vaccine and who are not willing to receive single dose of Ad26.COV2.S vaccine will continue to receive booster vaccination.
    Interventions:
    • Biological: Ad26.COV2.S
    • Biological: Placebo
  • Experimental: Cohort 2b
    Participants (healthy adults aged >=18 to <=55 years) will receive Ad26.COV2.S in the primary regimen or matching Placebo on Day 1 and Day 57, followed by booster vaccination at 8 months, 14 months, and 26 months (that is, 6 months, 12 months, or 24 months after completion of the primary regimen) with same dose or matching Placebo. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S vaccine and who are not willing to receive single dose of Ad26.COV2.S vaccine will continue to receive booster vaccination.
    Interventions:
    • Biological: Ad26.COV2.S
    • Biological: Placebo
  • Experimental: Cohort 3
    Participants (good or stable health adults aged >=65 years) will receive Ad26.COV2.S at 2 dose levels, as a single dose or 2 dose schedule with an 8-week interval or matching Placebo on Day 1 and Day 57. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S. If they choose not to receive Ad26.COV2.S they will be asked to continue to be followed in this study.
    Interventions:
    • Biological: Ad26.COV2.S
    • Biological: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 16, 2021)
1085
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2020)
1045
Estimated Study Completion Date  ICMJE February 2, 2024
Estimated Primary Completion Date December 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • All female participants of childbearing potential must have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration
  • Participant must have a body mass index (BMI) less than or equal to (<=) 30.0 kilograms per square meter (kg/m^2)
  • Applicable to Cohorts 1 and 2 only: Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, clinical laboratory assessments, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (COVID-19). Applicable to Cohort 3 only: In the investigator's clinical judgment, participant must be either in good or stable health Participants may have underlying illnesses such as hyperlipoproteinemia or hypothyroidism, as long as their symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe COVID-19 (participants may have medical conditions of mild severity (according to the Toxicity Grading Scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, Beta blockers, Alpha blockers at the same effective dose).

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 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 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)
  • Participant has a history of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
  • Participant has a positive diagnostic test result for SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) at screening
  • Participants with comorbidities that are or might be associated with an increased risk of progression to severe COVID-19, that is, 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 or type 2); serious heart conditions, including heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and (pulmonary) hypertension or high blood pressure; obesity (BMI >= 30 kg/m^2); chronic liver disease, including cirrhosis; sickle cell disease; thalassemia; cerebrovascular disease; neurologic conditions (dementia); smoking end stage renal disease; organ transplantation; cancer; HIV infection and other immunodeficiencies; hepatitis B infection; and sleep apnea. Applicable to Cohort 3 only: Participants may have hypertension of mild severity (according to the Toxicity Grading Scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, Beta blockers, Alpha blockers at the same effective dose)
  • Applicable to Cohorts 1 and 3 only: Participant currently working in an occupation with a high risk of exposure to SARS-CoV-2 (for example, health care worker or emergency response personnel) or considered at the investigator's discretion to be at increased risk to acquire COVID-19 for any other reason
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04436276
Other Study ID Numbers  ICMJE CR108828
2020-001483-28 ( EudraCT Number )
VAC31518COV1001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency
Responsible Party Janssen Vaccines & Prevention B.V.
Study Sponsor  ICMJE Janssen Vaccines & Prevention B.V.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
PRS Account Janssen Vaccines & Prevention B.V.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP