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

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: Ad26.COV2.S; Other: Placebo

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.

Note: The Informed Consent Form dated 27-Oct-2020 is final version of the study MASTER ICF, used by local countries to prepare the local language version of the ICF, which have been approved by the Ethics Committees.

And the highlighted text in the ICF document are the guidance for country specific adaptation.

• Study Type: Interventional
• Enrollment (Actual): 635
• Phase: Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité Research Organisation GmbH
  • Hamburg, Germany, 20251
    • CTC North GmbH & Co. KG, Am Universitätsklinikum Hamburg-Eppendorf
  • Rostock, Germany, 18057
    • Universitaetsmedizin Rostock
• Netherlands
  • Groningen, Netherlands, NZ 9728
    • PRA Health Sciences
  • Leiden, Netherlands, 2333 CL
    • Centre for Human Drug Research
  • Utrecht, Netherlands, 3584 CX
    • UMCU
• Spain
  • Madrid, Spain, 28046
    • Hosp. Univ. La Paz
  • Madrid, Spain, 28006
    • Hosp. Univ. de La Princesa
  • Santander, Spain, 39008
    • Hosp. Univ. Marques de Valdecilla
• United Kingdom
  • Liverpool, United Kingdom, L12 2AP
    • Alder Hey Hospital
  • London, United Kingdom, SW17 0RE
    • St George's, University of London
  • Manchester, United Kingdom, M13 9WL
    • Royal Manchester Children's Hospital
  • Southampton, United Kingdom, SO166YD
    • University Hospital Southampton NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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 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).	Biological: Ad26.COV2.S; All participants, both adults and adolescents, will receive intramuscular (IM) injections of Ad26.COV2.S.; Other Names: 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.
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).	Biological: Ad26.COV2.S; All participants, both adults and adolescents, will receive intramuscular (IM) injections of Ad26.COV2.S.; Other Names: 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.
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).	Biological: Ad26.COV2.S; All participants, both adults and adolescents, will receive intramuscular (IM) injections of Ad26.COV2.S.; Other Names: 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.
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.	Biological: Ad26.COV2.S; All participants, both adults and adolescents, will receive intramuscular (IM) injections of Ad26.COV2.S.; Other Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers at 28 Days After Vaccination 2	Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was less than or equal to the lower limit of quantification (<=LLOQ) and the post-baseline sample was greater than (>) LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (greater than or equal to [>=] 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were 50 percent (%) inhibitory concentration (IC50) of 58 and 12,800 international unit per milliliter (IU/mL) respectively.	28 days after Vaccination 2 (Day 85)
Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Spike Binding Antibodies Enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days After Vaccination 2	Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.	28 days after Vaccination 2 (Day 85)
Adults of Groups 1, 2 and 3: Antibody Geometric Mean Titers (GMTs) as Measured by VNA at 28 Days After Vaccination 2	Antibody GMTs as measured by VNA at 28 days after Vaccination 2 were reported.	28 days after Vaccination 2 (Day 85)
Adults of Groups 1, 2 and 3: Antibody Geometric Mean Concentrations (GMCs) as Measured by (S-ELISA) at 28 Days After Vaccination 2	Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 2 were reported.	28 days after Vaccination 2 (Day 85)
Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers at 28 Days After Vaccination 1	Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.	28 days after Vaccination 1 (Day 29)
Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 1	Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.	28 days after Vaccination 1 (Day 29)
Adults of Groups 4, 5 and 6: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1	Antibody GMTs as measured by VNA at 28 days after vaccination 1 were reported. LLOQ was 58 IU/mL.	28 days after Vaccination 1 (Day 29)
Adults of Groups 4, 5 and 6: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1	Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 1 were reported. The LLOQ was 50.3 IU/mL.	28 days after Vaccination 1 (Day 29)
Adults of Groups 9 and 10: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 2	Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.	28 days after Vaccination 2 ( Day 113)
Adults of Groups 9 and 10: Percentage of Participant With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 2	Percentage of participant with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.	28 days after Vaccination 2 (Day 113)
Adults of Groups 9 and 10: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 2	Antibody GMTs as measured by VNA at 28 days after Vaccination 2 were reported. The LLOQ was 58 IU/mL.	28 days after Vaccination 2 (Day 113)
Adults of Groups 9 and 10: Antibody GMCs as Measured by S-ELISA at 28 Days After Vaccination 2	Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 2 were reported. The LLOQ was 50.3 IU/mL.	28 Days after Vaccination 2 (Day 113)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1	Number of participants with solicited local AEs at 7 days after vaccination 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary for 7 days after vaccination 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.	7 days after Vaccination 1 (Day 8)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1	Number of participants with solicited systemic AEs at 7 days after vaccination 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree Celsius).	7 days after Vaccination 1 (Day 8)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 2	Number of participants with solicited local AEs at 7 days after vaccination 2 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary for 7 days post vaccination 2 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.	7 days after Vaccination 2 (Day 64 for Groups 1-6; Day 92 for Groups 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 2	Number of participants with solicited systemic AEs at 7 days after vaccination 2 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination 2 (Day of vaccination 2 and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree Celsius).	7 days after Vaccination 2 (Day 64 for Group 1-6; Day 92 for Group 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1	Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary.	28 days after Vaccination 1 (Day 29)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 2	Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary.	28 days After Vaccination 2 (Day 85 for Groups 1-6; Day 113 for Groups 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Serious Adverse Events (SAEs)	SAE is any untoward medical occurrence that at any dose may result 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.	Up to 1.5 years
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Adverse Events of Special Interest (AESIs)	AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.	Up to 1.5 years
Adolescents: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 1	Number of participants with solicited local AEs at 7 days after vaccination 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary for 7 days post vaccination 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.	7 Days After Vaccination 1 (Day 8)
Adolescents: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 1	Number of participants with solicited systemic AEs at 7 days after vaccination 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination 1 (Day of vaccination1 and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree Celsius).	7 Days After Vaccination 1 (Day 8)
Adolescents: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1	Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary.	28 Days After Vaccination 1 (Day 29)
Adolescents: Number of Participants With SAEs (Inclusive Multisystem Inflammatory Syndrome in Children [MIS-C])	SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.	Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years)
Adolescents: Number of Participants With AESIs	AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.	Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adults of Groups 1 to 5, Groups 7 and 9: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation	Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL, respectively.	7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9)
Adults of Groups 1 to 5, Groups 7 and 9: GMTs as Measured by VNA 7 Days After Antigen Presentation	Antibody GMTs as measured by VNA at 7 days after antigen presentation were reported.	7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9)
Adults of Groups 1 to 5 and Group 9: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation	Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.	7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9)
Adults of Group 7: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation	Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL. respectively.	Day 148
Adults of Groups 1 to 5 and Group 9: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation	Antibody GMCs as measured by S-ELISA 7 days after antigen presentation were reported.	7 Days after Antigen Presentation (Day 176 for Groups 1-5; Day 204 for Group 9)
Adults of Group 7: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation	Antibody GMCs as measured by S-ELISA 7 days after antigen presentation were reported.	Day 148
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Antigen Presentation	Number of participants with solicited local AEs at 7 days after antigen presentation were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary for 7 days after antigen presentation (day of antigen presentation and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.	7 Days After Antigen Presentation (Day 176 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 204 for Group 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Antigen Presentation	Number of participants with solicited systemic AEs at 7 days after antigen presentation were reported. An AE was any untoward medical occurrence in a Participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days after antigen presentation (Day of antigen presentation and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree Celsius).	7 Days After Antigen Presentation (Day 176 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 204 for Group 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Antigen Presentation	Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participants diary.	28 Days After Antigen Presentation (Day 197 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 225 for Group 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With SAEs After Antigen Presentation	SAE is any untoward medical occurrence that at any dose may result 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.	After antigen presentation until end of study (Day 170 up to 1.5 years for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 198 up to 1.5 years for Group 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With AESIs After Antigen Presentation	AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.	After antigen presentation until end of study (Day 170 up to 1.5 years for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 198 up to 1.5 years for Group 9 and 10)
Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA	Percentage of participants with neutralizing antibody titers to the wild-type SARS-CoV-2 virus expressing S-protein as measured by VNA were reported.	Days 197 and 393
Adults Group 9 and 10: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA	Percentage of participants with neutralizing antibody titers to the wild-type SARS-CoV-2 virus expressing S-protein as measured by VNA were reported.	Days 225 and 421
Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins	Percentage of participants with binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins were reported.	Days 197 and 393
Adults of Groups 9 and 10: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins	Percentage of participants with binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins were reported.	Days 225 and 421
Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 1 (Day 29)	Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.	28 Days After Vaccination 1 (Day 29)
Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 28 Days After Vaccination 1 (Day 29)	Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.	28 Days After Vaccination 1 (Day 29)
Adolescents: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1	Antibody GMTs as measured by VNA at 28 days after vaccination 1 (Day 29) were reported. LLOQ was 58 IU/mL	28 days After Vaccination 1 (Day 29)
Adolescents: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1	Antibody GMCs as measured by S-ELISA 28 days after vaccination was reported. LLOQ was 58 IU/mL	28 days After Vaccination 1 (Day 29)
Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA	Neutralizing antibody titers to the Wild-type SARS-CoV-2 virus expressing S protein measured by VNA was reported. LLOQ was 58 IU/mL.	Days 57, 85 and 169
Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA	Binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins as measured by ELISA was reported. LLOQ was 58 IU/mL.	Days 57, 85, 169
Adults: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation	Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.	7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Sadoff J, Le Gars M, Brandenburg B, Cardenas V, Shukarev G, Vaissiere N, Heerwegh D, Truyers C, de Groot AM, Jongeneelen M, Kaszas K, Tolboom J, Scheper G, Hendriks J, Ruiz-Guinazu J, Struyf F, Van Hoof J, Douoguih M, Schuitemaker H. Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials. Vaccine. 2022 Jul 30;40(32):4403-4411. doi: 10.1016/j.vaccine.2022.05.047. Epub 2022 Jun 3.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2020
• Primary Completion (Actual): March 9, 2022
• Study Completion (Actual): March 9, 2022

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CR108854; VAC31518COV2001 (Other Identifier: Janssen Vaccines & Prevention B.V.); 2020-002584-63 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No