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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 : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

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 in adults (18-65 years or older) and to assess the safety and reactogenicity of Ad26.COV2.S, administered IM as 2-dose or 1-dose schedule 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).

Condition or disease Intervention/treatment Phase
Healthy Biological: Ad26.COV2.S Other: Placebo Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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) and for adolescents, the study will consist of a screening phase (28 days), a vaccination phase (2 months), a booster vaccination 12 months after the first vaccination, and a follow-up phase (12 months after the booster vaccination). 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 25 months for adolescents group (Groups A to F). 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : August 28, 2020
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : March 26, 2023

Arm Intervention/treatment
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 receive 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).
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 Groups C and F will receive at least one injection of 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 receive 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).
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 Groups C and F will receive at least one injection of 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 receive 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).
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 Groups C and F will receive at least one injection of placebo.

Experimental: Groups A-C
Participants will receive 2-dose Ad26.COV2.S vaccination regimen at Days 1 and 57 at fixed dose level (Group B) or placebo (Group C ). A booster vaccination will be provided 12 months after the first vaccination. At approximately 6 months of study participation (unblinded phase), participants in Group C initially receiving placebo will receive 2 doses of Ad26.COV2.S vaccine at a single dose level, at a 56-day interval.
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 Groups C and F will receive at least one injection of placebo.

Experimental: Groups D-F
Participants will receive 2-dose Ad26.COV2.S vaccination regimen at Days 1 and 57 at fixed dose level (Group E) or single dose Ad26.COV2.S vaccination regimen at fixed dose level (Group D) or placebo (Group F). A booster vaccination will be provided 12 months after the first vaccination. At approximately 6 months of study participation (unblinded phase), participants in Group F initially receiving placebo will receive 2 doses of Ad26.COV2.S vaccine at a single dose level, at a 56-day interval.
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 Groups C and F will receive at least one injection of placebo.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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 were reported. The antibody levels elicited by the vaccine were measured by ELISA.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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 were reported. The antibody levels elicited by the vaccine were measured by VNA.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. Groups A-F: 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.

  29. Groups A-F: 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.

  30. Groups A-F: 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.

  31. Groups A-F: Number of Participants with SAEs [ Time Frame: Up to Day 672 ]
    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.

  32. Groups A-F: Number of Participants with AESIs [ Time Frame: Up to Day 672 ]
    Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.

  33. Groups A-F: 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.

  34. Groups A-F: Virus Neutralization Assay GMTs 28 Days After Vaccination 1 Assessed by Humoral Immune Response [ Time Frame: 28 Days after Vaccination 1 (Day 29) ]
    Non-inferiority (NI) will be assessed in terms of humoral immune response expressed by the GMTs of Virus Neutralization Assay.

  35. Groups A-F: Serological Response to Vaccination as Measured by 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.

  36. Groups A-F: Virus Neutralization Assay GMTs 28 Days After Vaccination 2 Assessed by Humoral Immune Response [ Time Frame: 28 Days after Vaccination 2 (Day 85) ]
    NI will be assessed in terms of humoral immune response expressed by the GMTs of Virus Neutralization Assay.

  37. Groups 1-6: Virus Neutralization Assay GMTs 28 Days After Vaccination 1 Assessed by Humoral Immune Response [ Time Frame: 28 days after Vaccination 1 (Day 29) ]
    NI will be assessed in terms of humoral immune response expressed by the GMTs of Virus Neutralization Assay.

  38. Groups 7-8: Virus Neutralization Assay GMTs 28 Days After Vaccination 1 Assessed by Humoral Immune Response [ Time Frame: 28 days after Vaccination 1 (Day 29) ]
    NI will be assessed in terms of humoral immune response expressed by the GMTs of Virus Neutralization Assay.

  39. Groups 9-10: Virus Neutralization Assay GMTs 28 Days After Vaccination 1 Assessed by Humoral Immune Response [ Time Frame: 28 days after Vaccination 1 (Day 29) ]
    NI will be assessed in terms of humoral immune response expressed by the GMTs of Virus Neutralization Assay.

  40. Groups 1-6: Virus Neutralization Assay GMTs 28 Days After Vaccination 2 Assessed by Humoral Immune Response [ Time Frame: 28 Days after Vaccination 2 (Day 85) ]
    NI will be assessed in terms of humoral immune response expressed by the GMTs of Virus Neutralization Assay.

  41. Groups 7-8: Virus Neutralization Assay GMTs 28 Days After Vaccination 2 Assessed by Humoral Immune Response [ Time Frame: 28 Days after Vaccination 2 (Day 57) ]
    NI will be assessed in terms of humoral immune response expressed by the GMTs of Virus Neutralization Assay.

  42. Groups 9-10: Virus Neutralization Assay GMTs 28 Days After Vaccination 2 Assessed by Humoral Immune Response [ Time Frame: 28 Days after Vaccination 2 (Day 113) ]
    NI will be assessed in terms of humoral immune response expressed by the GMTs of Virus Neutralization Assay.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 were reported. The antibody levels elicited by the vaccine were measured by VNA.

  4. 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 were reported. The antibody levels elicited by the vaccine were measured by ELISA.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Groups A-F: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 Days After Vaccination 1 and 2 [ Time Frame: 28 Days after Vaccination 1 (Day 29); 28 Days after Vaccination 2 (Day 85) ]
    Serological response to vaccination as measured by VNA titers 28 days after Vaccination 1 and 2 will be reported.

  13. Groups A-F: Serological Response to Vaccination as Measured by ELISA 28 Days After Vaccination 1 and 2 [ Time Frame: 28 Days after Vaccination 1 (Day 29); 28 Days after Vaccination 2 (Day 85) ]
    Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, EU/mL) 28 days after Vaccination 1 and 2 will be reported.

  14. Groups A-F: Enzyme-linked Immunosorbent Assay Geometric Mean Concentrations (GMCs) 28 Days After Vaccination 1 and 2 [ Time Frame: 28 Days after Vaccination 1 (Day 29); 28 Days after Vaccination 2 (Day 85) ]
    The GMCs for vaccine were reported. The antibody levels elicited by the vaccine were measured by ELISA.

  15. Groups A-F: Serological Response to Vaccination as Measured by VNA Titers 7 Days After the Booster Vaccination [ Time Frame: 7 days after booster vaccination (Day 344) ]
    Serological response to vaccination as measured by VNA titers 7 days after the booster vaccination will be reported.

  16. Groups A-F: Serological Response to Vaccination as Measured by ELISA 7 Days After Booster Vaccination [ Time Frame: 7 days after booster vaccination (Day 344) ]
    Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, EU/mL) 7 days after the booster vaccination will be reported.

  17. Groups A-F: VNA GMT 7 Days After Booster Vaccination [ Time Frame: 7 days after booster vaccination (Day 344) ]
    The GMTs for vaccine were reported. The antibody levels elicited by the vaccine were measured by VNA.

  18. Groups A-F: Enzyme-linked Immunosorbent Assay GMCs 7 Days After Booster Vaccination [ Time Frame: 7 days after booster vaccination (Day 344) ]
    The GMCs for vaccine were reported. The antibody levels elicited by the vaccine were measured by ELISA.

  19. Groups A-F: Number of Participants with Solicited Local AEs for 7 Days After Booster Vaccination [ Time Frame: 7 days after booster vaccination (Up to 161 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 booster vaccination.

  20. Groups A-F: Number of Participants with Solicited Systemic AEs for 7 Days After Booster Vaccination [ Time Frame: 7 days after booster vaccination (Up to 161 Days) ]
    Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) will be noted in the participant diary after 7 days of booster vaccination.

  21. Groups A-F: Number of Participants with Unsolicited AEs for 28 Days After Booster Vaccination [ Time Frame: 28 days after booster vaccination (Up to 140 Days) ]
    Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.

  22. Groups A-F: Number of Participants with SAEs After Booster Vaccination [ Time Frame: Up to Day 336 ]
    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.

  23. Groups A-F: Number of Participants with AESIs After Booster Vaccination [ Time Frame: Up to Day 336 ]
    Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.

  24. Groups A-F: SARS-CoV-2 Neutralizing Antibody Titers as Assessed by VNA [ Time Frame: Up to Day 672 ]
    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.

  25. Groups A-F: SARS-CoV-2 Binding Antibodies Measured as Assessed by ELISA [ Time Frame: Up to Day 672 ]
    SARS-CoV-2 binding antibodies as assessed by ELISA to measure humoral immune response will be reported.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535453


Locations
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Germany
Charité Research Organisation GmbH
Berlin, Germany, 10117
CTC North GmbH & Co. KG, Am Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20251
Universitaetsmedizin Rostock
Rostock, Germany, 18057
Netherlands
PRA Health Sciences
Groningen, Netherlands, NZ 9728
Centre for Human Drug Research
Leiden, Netherlands, 2333 CL
UMCU
Utrecht, Netherlands, 3584 CX
Spain
Hosp. Univ. de La Princesa
Madrid, Spain, 28006
Hosp. Univ. La Paz
Madrid, Spain, 28046
Hosp. Univ. Marques de Valdecilla
Santander, Spain, 39008
United Kingdom
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Alder Hey Hospital
Liverpool, United Kingdom, L12 2AP
St George's, University of London
London, United Kingdom, SW17 0RE
Royal Manchester Children's Hospital
Manchester, United Kingdom, M13 9WL
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO166YD
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Investigators
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Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
Additional Information:
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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT04535453    
Other Study ID Numbers: CR108854
VAC31518COV2001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
2020-002584-63 ( EudraCT Number )
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No