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A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults and Adolescents

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: NCT04535453
Recruitment Status : Active, not recruiting
First Posted : September 2, 2020
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Tracking Information
First Submitted Date  ICMJE August 27, 2020
First Posted Date  ICMJE September 2, 2020
Last Update Posted Date November 24, 2021
Actual Study Start Date  ICMJE August 28, 2020
Estimated Primary Completion Date March 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2021)
  • Groups 1-6: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 Days After Vaccination 2 [ Time Frame: 28 days after Vaccination 2 (Day 85) ]
    Serological response to vaccination as measured by VNA titers 28 days after Vaccination 2 will be reported.
  • Groups 1-6: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After Vaccination 2 [ Time Frame: 28 days after Vaccination 2 (Day 85) ]
    Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, ELISA Units/mL [EU/mL]) 28 days after Vaccination 2 will be reported.
  • Groups 1-6: Virus Neutralization Assay Geometric Mean Titer (GMT) 28 Days After Vaccination 2 [ Time Frame: 28 Days after Vaccination 2 (Day 85) ]
    The GMTs for vaccine will be reported. The antibody levels elicited by the vaccine will be measured by VNA.
  • Groups 1-6: Enzyme-linked Immunosorbent Assay Geometric Mean Concentrations (GMCs) 28 Days After Vaccination 2 [ Time Frame: 28 Days after Vaccination 2 (Day 85) ]
    The GMCs for vaccine will be reported. The antibody levels elicited by the vaccine will be measured by ELISA.
  • Groups 1-6: Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 1 [ Time Frame: 28 Days after Vaccination 1 (Day 29) ]
    Serological response to vaccination as measured by VNA titers 28 days after Vaccination 1 will be reported.
  • Groups 1-6: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay 28 Days After Vaccination 1 [ Time Frame: 28 Days after Vaccination 1 (Day 29) ]
    Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, EU/mL) 28 days after Vaccination 1 will be reported.
  • Groups 1-6: Virus Neutralization Assay Geometric Mean Titer 28 Days After Vaccination 1 [ Time Frame: 28 Days after Vaccination 1 (Day 29) ]
    The GMTs for vaccine will be reported. The antibody levels elicited by the vaccine will be measured by VNA.
  • Groups 1-6: Enzyme-Linked Immunosorbent Assay Geometric Mean Concentrations 28 Days After Vaccination 1 [ Time Frame: 28 Days after Vaccination 1 (Day 29) ]
    The GMCs for vaccine will be reported. The antibody levels elicited by the vaccine will be measured by ELISA.
  • Groups 7-8: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 Days After Vaccination 2 [ Time Frame: 28 days after Vaccination 2 (Day 57) ]
    Serological response to vaccination as measured by VNA titers 28 days after Vaccination 2 will be reported.
  • Groups 7-8: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay 28 Days After Vaccination 2 [ Time Frame: 28 days after Vaccination 2 (Day 57) ]
    Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, EU/mL) 28 days after Vaccination 2 will be reported.
  • Groups 7-8: Virus Neutralization Assay GMTs 28 Days After Vaccination 2 [ Time Frame: 28 days after Vaccination 2 (Day 57) ]
    The GMTs for vaccine were reported. The antibody levels elicited by the vaccine were measured by VNA.
  • Groups 7-8: Enzyme-linked Immunosorbent Assay Geometric Mean Concentrations 28 Days After Vaccination 2 [ Time Frame: 28 days after Vaccination 2 (Day 57) ]
    The GMCs for vaccine were reported. The antibody levels elicited by the vaccine were measured by S-ELISA.
  • Groups 9-10: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 Days After Vaccination 2 [ Time Frame: 28 days after Vaccination 2 (Day 113) ]
    Serological response to vaccination as measured by VNA titers 28 days after Vaccination 2 will be reported.
  • Groups 9-10: Serological Response to Vaccination as Measured by ELISA 28 Days After Vaccination 2 [ Time Frame: 28 days after Vaccination 2 (Day 113) ]
    Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, EU/mL) 28 days after Vaccination 2 will be reported.
  • Groups 9-10: Virus Neutralization Assay GMTs 28 Days After Vaccination 2 [ Time Frame: 28 days after Vaccination 2 (Day 113) ]
    The GMTs for vaccine will be reported. The antibody levels elicited by the vaccine will be measured by VNA.
  • Groups 9-10: Enzyme-linked Immunosorbent Assay GMCs 28 Days After Vaccination 2 [ Time Frame: 28 Days after Vaccination 2 (Day 113) ]
    The GMCs for vaccine will be reported. The antibody levels elicited by the vaccine will be measured by ELISA.
  • Groups 1-6: Number of Participants with Solicited Local AEs for 7 Days After Each Vaccination [ Time Frame: 7 days after each vaccination (Up to 64 Days) ]
    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.
  • Groups 7-8: Number of Participants with Solicited Local AEs for 7 Days After Each Vaccination [ Time Frame: 7 days after each vaccination (Up to 36 Days) ]
    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.
  • Groups 9-10: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination [ Time Frame: 7 days after each vaccination (Up to 92 Days) ]
    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.
  • Groups 1-6: Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination [ Time Frame: 7 days after each vaccination (Up to 64 Days) ]
    Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary after 7 days of each vaccination.
  • Groups 7-8: Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination [ Time Frame: 7 days after each vaccination (Up to 36 Days) ]
    Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary after 7 days of each vaccination.
  • Groups 9-10: Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination [ Time Frame: 7 days after each vaccination (Up to 92 Days) ]
    Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary after 7 days of each vaccination.
  • Groups 1-6: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination [ Time Frame: 28 days after each vaccination (Up to 85 Days) ]
    Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
  • Groups 7-8: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination [ Time Frame: 28 days after each vaccination (Up to 57 Days) ]
    Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
  • Groups 9-10: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination [ Time Frame: 28 days after each vaccination (Up to 113 Days) ]
    Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
  • Groups 1-10: Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Day 421 ]
    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.
  • Groups 1-10: Number of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Up to Day 421 ]
    Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
  • Groups A-C: Number of Participants with Solicited Local AEs for 7 Days After Vaccination [ Time Frame: 7 days after vaccination (Day 8) ]
    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 7 days after vaccination.
  • Groups A-C: Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination [ Time Frame: 7 days after vaccination (Day 8) ]
    Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary after 7 days of vaccination.
  • Groups A-C: Number of Participants with Unsolicited AEs for 28 Days After Vaccination [ Time Frame: 28 days after vaccination (Day 29) ]
    Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
  • Groups A-C: Number of Participants with SAEs [ Time Frame: Up to Day 337 ]
    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.
  • Groups A-C: Number of Participants with AESIs [ Time Frame: Up to Day 337 ]
    Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2020)
  • Groups 1-6: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 days after Vaccination 2 [ Time Frame: 28 days after Vaccination 2 (Day 85) ]
    Serological response to vaccination as measured by VNA titers 28 days after Vaccination 2 will be reported.
  • Groups 1-6: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 days after Vaccination 2 [ Time Frame: 28 days after Vaccination 2 (Day 85) ]
    Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, ELISA Units/mL [EU/mL]) 28 days after Vaccination 2 will be reported.
  • Groups 1-6: Virus Neutralization Assay Geometric Mean Titer (GMT) 28 Days After Vaccination 2 [ Time Frame: 28 Days after Vaccination 2 (Day 85) ]
    The GMTs for vaccine were reported. The antibody levels elicited by the vaccine were measured by VNA.
  • Groups 1-6: Enzyme-linked Immunosorbent Assay Geometric Mean Concentrations (GMCs) 28 Days After Vaccination 2 [ Time Frame: 28 Days after Vaccination 2 (Day 85) ]
    The GMCs for vaccine were reported. The antibody levels elicited by the vaccine were measured by ELISA.
  • Groups 1-6: Serological Response to Vaccination as Measured by VNA Titers 28 days after Vaccination 1 [ Time Frame: 28 Days after Vaccination 1 (Day 29) ]
    Serological response to vaccination as measured by VNA titers 28 days after Vaccination 1 will be reported.
  • Groups 1-6: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay 28 days after Vaccination 1 [ Time Frame: 28 Days after Vaccination 1 (Day 29) ]
    Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, EU/mL) 28 days after Vaccination 1 will be reported.
  • Groups 1-6: Virus Neutralization Assay Geometric Mean Titer 28 Days After Vaccination 1 [ Time Frame: 28 Days after Vaccination 1 (Day 29) ]
    The GMTs for vaccine were reported. The antibody levels elicited by the vaccine were measured by VNA.
  • Groups 1-6: Enzyme-Linked Immunosorbent Assay Geometric Mean Concentrations 28 Days After Vaccination 1 [ Time Frame: 28 Days after Vaccination 1 (Day 29) ]
    The GMTs for vaccine were reported. The antibody levels elicited by the vaccine were measured by ELISA.
  • Groups 7-8: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 days after Vaccination 2 [ Time Frame: 28 days after Vaccination 2 (Day 85) ]
    Serological response to vaccination as measured by VNA titers 28 days after Vaccination 2 will be reported.
  • Groups 7-8: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay 28 days after Vaccination 2 [ Time Frame: 28 days after Vaccination 2 (Day 57) ]
    Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, EU/mL) 28 days after Vaccination 2 will be reported.
  • Groups 7-8: Virus Neutralization Assay GMTs 28 Days After Vaccination 2 [ Time Frame: 28 Days after Vaccination 2 (Day 57) ]
    The GMTs for vaccine were reported. The antibody levels elicited by the vaccine were measured by VNA.
  • Groups 7-8: Enzyme-linked Immunosorbent Assay Geometric Mean Concentrations 28 Days After Vaccination 2 [ Time Frame: 28 Days after Vaccination 2 (Day 57) ]
    The GMCs for vaccine were reported. The antibody levels elicited by the vaccine were measured by ELISA.
  • Groups 9-10: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 days after Vaccination 2 [ Time Frame: 28 days after Vaccination 2 (Day 113) ]
    Serological response to vaccination as measured by VNA titers 28 days after Vaccination 2 will be reported.
  • Groups 9-10: Serological Response to Vaccination as Measured by ELISA 28 days after Vaccination 2 [ Time Frame: 28 days after Vaccination 2 (Day 113) ]
    Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, EU/mL) 28 days after Vaccination 2 will be reported.
  • Groups 9-10: Virus Neutralization Assay GMT 28 Days After Vaccination 2 [ Time Frame: 28 Days after Vaccination 2 (Day 113) ]
    The GMTs for vaccine were reported. The antibody levels elicited by the vaccine were measured by VNA.
  • Groups 9-10: Enzyme-linked Immunosorbent Assay GMCs 28 Days After Vaccination 2 [ Time Frame: 28 Days after Vaccination 2 (Day 113) ]
    The GMCs for vaccine were reported. The antibody levels elicited by the vaccine were measured by ELISA.
  • Groups 1-6: Number of Participants with Solicited Local AEs for 7 Days after Each Vaccination [ Time Frame: 7 days after each vaccination (Up to 64 Days) ]
    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.
  • Groups 7-8: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Each Vaccination [ Time Frame: 7 days after each vaccination (Up to 64 Days) ]
    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.
  • Groups 9-10: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Each Vaccination [ Time Frame: 7 days after each vaccination (Up to 64 Days) ]
    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.
  • Groups 1-6: Number of Participants with Solicited Systemic AEs for 7 Days after Each Vaccination [ Time Frame: 7 days after each vaccination (Up to 64 Days) ]
    Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary after 7 days of each vaccination.
  • Groups 7-8: Number of Participants with Solicited Systemic AEs for 7 Days after Each Vaccination [ Time Frame: 7 days after each vaccination (Up to 64 Days) ]
    Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary after 7 days of each vaccination.
  • Groups 9-10: Number of Participants with Solicited Systemic AEs for 7 Days after Each Vaccination [ Time Frame: 7 days after each vaccination (Up to 64 Days) ]
    Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary after 7 days of each vaccination.
  • Groups 1-6: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination [ Time Frame: 28 days after each vaccination (Up to 85 Days) ]
    Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
  • Groups 7-8: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination [ Time Frame: 28 days after each vaccination (Up to 85 Days) ]
    Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
  • Groups 1-10: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination [ Time Frame: 28 days after each vaccination (Up to 85 Days) ]
    Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
  • Groups 1-10: Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Day 450 ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2021)
  • Groups 1-5, 7 and 9: Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation [ Time Frame: 7 days after antigen presentation (Day 176 [Groups 1-5]; Day 148 [Group 7]; Day 204 [Group 9]) ]
    Serological response to vaccination as measured by VNA titers 7 days after antigen presentation will be reported.
  • Groups 1-5, 7 and 9: Serological Response to Vaccination as Measured by ELISA 7 Days After Antigen Presentation [ Time Frame: 7 days after antigen presentation (Day 176 [Groups 1-5]; Day 148 [Group 7]; Day 204 [Group 9]) ]
    Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, EU/mL) 7 days after antigen presentation will be reported.
  • Groups 1-5, 7 and 9: VNA GMT 7 Days After Antigen Presentation [ Time Frame: 7 days after antigen presentation (Day 176 [Groups 1-5]; Day 148 [Group 7]; Day 204 [Group 9]) ]
    The GMTs for vaccine will be reported. The antibody levels elicited by the vaccine will be measured by VNA.
  • Groups 1-5, 7 and 9: Enzyme-Linked Immunosorbent Assay Geometric Mean Concentrations 7 Days After Antigen Presentation [ Time Frame: 7 days after antigen presentation (Day 176 [Groups 1-5]; Day 148 [Group 7]; Day 204 [Group 9]) ]
    The GMCs for vaccine will be reported. The antibody levels elicited by the vaccine will be measured by ELISA.
  • Groups 1-5, 7 and 9: Number of Participants with Solicited Local Adverse Events for 7 Days After Antigen Presentation [ Time Frame: 7 days after antigen presentation (Day 176 [Groups 1-5]; Day 148 [Group 7]; Day 204 [Group 9]) ]
    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 7 days after antigen presentation.
  • Groups 1-5, 7 and 9: Number of Participants with Solicited Systemic Adverse Events for 7 Days After Antigen Presentation [ Time Frame: 7 days after antigen presentation (Day 176 [Groups 1-5]; Day 148 [Group 7]; Day 204 [Group 9]) ]
    Solicited systemic AEs include (body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary 7 days after antigen presentation.
  • Groups 1-5, 7 and 9: Number of Participants with Unsolicited AEs for 28 Days After Antigen Presentation [ Time Frame: 28 days after antigen presentation (Day 197 [Groups 1-5]; Day 169 [Group 7]; Day 225 [Group 9]) ]
    Number of participants with unsolicited AEs for 28 days after antigen presentation will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
  • Groups 1-5, 7 and 9: Number of Participants with Serious Adverse Events Throughout the Study [ Time Frame: Up to Day 421 ]
    Number of participants with SAEs throughout the study (from antigen presentation until end of the study) will be reported. 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.
  • Groups 1-5, 7 and 9: Number of Participants with AESIs Throughout the Study [ Time Frame: Up to Day 421 ]
    Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
  • Groups 1-10: SARS-CoV-2 Neutralizing Antibody Titers as Assessed by VNA [ Time Frame: Up to Day 421 ]
    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.
  • Groups 1-10: SARS-CoV-2 Binding Antibodies Measured as Assessed by ELISA [ Time Frame: Up to Day 421 ]
    SARS-CoV-2 binding antibodies as assessed by ELISA to measure humoral immune response will be reported.
  • Groups A-C: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 Days After Vaccination [ Time Frame: 28 Days after Vaccination (Day 29) ]
    Serological response to vaccination as measured by VNA titers 28 days after Vaccination will be reported.
  • Groups A-C: Serological Response to Vaccination as Measured by ELISA 28 Days After Vaccination [ Time Frame: 28 Days after Vaccination (Day 29) ]
    Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, EU/mL) 28 days after Vaccination will be reported.
  • Groups A-C: VNA GMT 28 Days After Vaccination [ Time Frame: 28 Days after Vaccination (Day 29) ]
    The GMTs for vaccine will be reported. The antibody levels elicited by the vaccine will be measured by VNA.
  • Groups A-C: Enzyme-linked Immunosorbent Assay Geometric Mean Concentrations (GMCs) 28 Days After Vaccination [ Time Frame: 28 Days after Vaccination (Day 29) ]
    The GMCs for vaccine will be reported. The antibody levels elicited by the vaccine will be measured by ELISA.
  • Groups A-C: SARS-CoV-2 Neutralizing Antibody Titers as Assessed by VNA [ Time Frame: Up to Day 337 ]
    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.
  • Groups A-C: SARS-CoV-2 Binding Antibodies Measured as Assessed by ELISA [ Time Frame: Up to Day 337 ]
    SARS-CoV-2 binding antibodies as assessed by ELISA to measure humoral immune response will be reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2020)
  • Groups 1-10: Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation [ Time Frame: 7 days after antigen presentation (Day 176 [Groups 1-6]; Day 148 [Groups 7-8]; Day 204 [Groups 9-10]) ]
    Serological response to vaccination as measured by VNA titers 7 days after antigen presentation will be reported.
  • Groups 1-10: Serological Response to Vaccination as Measured by ELISA 7 Days After Antigen Presentation [ Time Frame: 7 days after antigen presentation (Day 176 [Groups 1-6]; Day 148 [Groups 7-8]; Day 204 [Groups 9-10]) ]
    Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, EU/mL) 7 days after antigen presentation will be reported.
  • Groups 1-10: VNA GMT 7 Days After Antigen Presentation [ Time Frame: 7 days after antigen presentation (Day 176 [Groups 1-6]; Day 148 [Groups 7-8]; Day 204 [Groups 9-10]) ]
    The GMTs for vaccine were reported. The antibody levels elicited by the vaccine were measured by VNA.
  • Groups 1-10: Enzyme-Linked Immunosorbent Assay Geometric Mean Concentrations 7 Days After Antigen Presentation [ Time Frame: 7 days after antigen presentation (Day 176 [Groups 1-6]; Day 148 [Groups 7-8]; Day 204 [Groups 9-10]) ]
    The GMCs for vaccine were reported. The antibody levels elicited by the vaccine were measured by ELISA.
  • Groups 1-10: Number of Participants with Solicited Local Adverse Events for 7 Days After Antigen Presentation [ Time Frame: 7 days after antigen presentation (Day 176 [Groups 1-6]; Day 148 [Groups 7-8]; Day 204 [Groups 9-10]) ]
    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 7 days after antigen presentation.
  • Groups 1-10: Number of Participants with Solicited Systemic Adverse Events for 7 Days After Antigen Presentation [ Time Frame: 7 days after vaccination (Up to Day 175 [Groups 1-6]; Day 148 [Groups 7-8]; Day 204 [Groups 9-10]) ]
    Solicited systemic AEs include (body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary 7 days after antigen presentation.
  • Groups 1-10: Number of Participants with Unsolicited AEs for 28 Days After Antigen Presentation [ Time Frame: 28 days after antigen presentation (Day 197 [Groups 1-6]; Day 169 [Groups 7-8]; Day 225 [Groups 9-10]) ]
    Number of participants with unsolicited AEs for 28 days after antigen presentation will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
  • Groups 1-10: Number of Participants with Serious Adverse Events Throughout the Study [ Time Frame: Up to Day 450 ]
    Number of participants with SAEs throughout the study (from antigen presentation until end of the study) will be reported. 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.
  • Groups 1-10: SARS-CoV-2 Neutralizing Antibody Titers as Assessed by VNA [ Time Frame: Up to Day 450 ]
    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.
  • Groups 1-10: SARS-CoV-2 Binding Antibodies Measured as Assessed by ELISA [ Time Frame: Up to Day 450 ]
    SARS-CoV-2 binding antibodies as assessed by ELISA to measure humoral immune response will be reported.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults and Adolescents
Official Title  ICMJE 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 and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive
Brief Summary The primary purpose of this study is to assess humoral immune responses of 3 dose levels of Ad26.COV2.S administered intramuscularly (IM) as a 2-dose schedule (56 days apart); Ad26.COV2.S administered IM as a single vaccination; safety and reactogenicity of Ad26.COV2.S administered IM as a 2-dose or a single-dose schedule in adults (18-65 years or older) and to assess the safety and reactogenicity of Ad26.COV2.S, administered IM as single dose in adolescents (12-17 years) and to test both compressed and expanded 2-dose schedules of Ad26.COV2.S (28 and 84 days apart) in adults (18-55 years and 65 years or older).
Detailed Description The aim of the COVID-19 vaccine clinical development program is to develop a safe and effective vaccine for the prevention of COVID-19. Currently, there is only limited availability of authorized/licensed vaccines for the prevention of coronavirus disease-2019 (COVID-19). Ad26.COV2.S (also known as Ad26COVS1) is a monovalent vaccine composed of a recombinant, replication incompetent adenovirus type 26 (Ad26) vector, constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus spike (S) protein, which will be assessed in this study. Also, different vaccination intervals and multiple lower dose levels compared to the dose levels in the first in human study (VAC31518COV1001 [NCT04436276]) will be assessed. For adults, the study consists of: screening phase (28 days), vaccination phase (1-3 months) depending on the vaccination interval, and follow-up (12 months). The study duration is approximately 15 months (Groups 1-6, 8, 10 and Group 7 [to participants for whom vaccination 2 was delayed]), 14 months (Group 7), and 16 months (Group 9) in adult groups and approximately 13 months for adolescents group (Groups A to C). The adverse events and other safety assessments including vital signs measurements (heart rate, supine systolic and diastolic blood pressure, respiratory rate, and body temperature), and physical examinations will be assessed during the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: Ad26.COV2.S
    All participants, both adults and adolescents, will receive intramuscular (IM) injections of Ad26.COV2.S.
    Other Name: JNJ-78436735, Ad26COVS1
  • Other: Placebo
    Adult participants in Groups 4, 5, 6, 8, and 10, and adolescent participants in Group C will receive at least one injection of placebo.
Study Arms  ICMJE
  • Experimental: Groups 1-6
    Participants will receive a 2-dose Ad26.COV2.S vaccination regimen at Days 1 and 57 at different dose levels (Groups 1-3), or a single-dose Ad26.COV2.S vaccination regimen at different dose levels (Groups 4-5), or placebo (Group 6). At unblinded phase, participants in Group 6 initially receiving placebo will be offered 2 doses of Ad26.COV2.S vaccine at a single dose level, at a 28-day interval. Participants will also receive a single antigen presentation injection with single dose level of Ad26.COV2.S at 4 months after second vaccination (Groups 1-5) or placebo (Group 6).
    Interventions:
    • Biological: Ad26.COV2.S
    • Other: Placebo
  • Experimental: Groups 7-8
    Participants will receive 2-dose Ad26.COV2.S vaccination regimen at Days 1 and 29 at fixed dose level (Groups 7) or placebo (Groups 8). At unblinded phase, participants in Group 8 initially receiving placebo will be offered 2 doses of Ad26.COV2.S vaccine at a single dose level, at a 28-day interval. Participants will also receive a single antigen presentation injection with single dose level of Ad26.COV2.S at 4 months after second vaccination (Group 7) or placebo (Group 8).
    Interventions:
    • Biological: Ad26.COV2.S
    • Other: Placebo
  • Experimental: Groups 9-10
    Participants will receive 2-dose Ad26.COV2.S vaccination regimen at Days 1 and 85 at fixed dose level (Group 9) or placebo (Group 10). At unblinded phase, participants in Group 10 initially receiving placebo will be offered 2 doses of Ad26.COV2.S vaccine at a single dose level, at a 28-day interval. Participants will also receive a single antigen presentation injection with single dose level of Ad26.COV2.S at 4 months after second vaccination (Group 9) or placebo (Group 10).
    Interventions:
    • Biological: Ad26.COV2.S
    • Other: Placebo
  • Experimental: Groups A-C
    Participants will receive a single dose Ad26.COV2.S vaccination regimen at Day 1 at fixed dose level (Groups A and B) or placebo (Group C). At approximately 6 months of study participation (unblinded phase), participants in Group C initially receiving placebo will receive Ad26.COV2.S vaccine at a single dose level, at a 56-day interval.
    Interventions:
    • Biological: Ad26.COV2.S
    • Other: Placebo
Publications * Not Provided

*   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: August 31, 2021)
635
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2020)
550
Estimated Study Completion Date  ICMJE March 28, 2022
Estimated Primary Completion Date March 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

For Adults

  • Participant must have a body mass index (BMI) less than (<) 30.0 kilogram per meter square (kg/m^2)
  • Participant is 18 to 55 years of age, inclusive, or 65 years of age or older on the day of signing the informed consent form (ICF).
  • 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 coronavirus disease-2019 (COVID-19), except for smoking and mild hypertension, which are 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 and mild hypertension, which are 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
  • Participant will be included on the basis of physical examination, medical history, and vital signs
  • 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
  • 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

For Adolescents:

  • Participant is 12 to 17 years of age, inclusive, on the day of signing the informed consent form (ICF)
  • Participants must have signed an ICF (or their legally acceptable representative or parent(s) [preferably both parents if available or as per local requirements] must sign) indicating that they understand the purpose of, and procedures required for, the study, are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures, and are willing (or the parents are willing for their adolescent) to participate in the study. Informed assent must be obtained from adolescents, depending on local regulations and practice
  • 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

Exclusion Criteria:

For Adults

  • 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 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 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 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
  • 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 Ig or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine (including investigational Adenoviral-vectored vaccines) 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 For Adolescents
  • 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)
  • Participants with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the participant if he/she participates in the study
  • Participant has a history of Kawasaki disease
  • Participant has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, 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 Germany,   Netherlands,   Spain,   United Kingdom
Removed Location Countries Brazil,   Canada,   United States
 
Administrative Information
NCT Number  ICMJE NCT04535453
Other Study ID Numbers  ICMJE CR108854
VAC31518COV2001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
2020-002584-63 ( EudraCT Number )
Has Data Monitoring Committee Yes
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 November 2021

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