A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive

Study Overview
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Brief Summary
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The primary purpose of this study is to assess the safety, reactogenicity, and humoral immune response of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule or as a 2-dose schedule (56-day interval) in adolescents.

Detailed Description
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Available safety, immunogenicity and efficacy data from the Ad26.COV2.S vaccine development program supports initiating evaluation of Ad26.COV2.S in the pediatric population. Ad26.COV2.S will be evaluated in the pediatric population through a dose-confirmation approach. Ad26.COV2.S (also known as Ad26COVS1, VAC31518, JNJ-78436735) is a monovalent vaccine composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector, constructed to encode the severe acute respiratory syndrome coronavirus(-2) (SARS-CoV-2) spike (S) protein, stabilized in its prefusion conformation. The study duration from screening until the last follow-up visit will be, excluding the 28-day screening phase, 8 months (Groups 4-6) to 12 months (Groups 1-3), consisting of 12-month study duration comprising a study period (6-months) including vaccination with a 1 active dose and a placebo vaccination (56-day interval), followed by a booster vaccination at 6 months and follow-up (safety and immunogenicity) until at least 6 months after booster vaccination (Groups 1-3) and 8 month study duration comprising 2 active doses (56-day interval) and follow-up (safety and immunogenicity) until at least 6 months after second vaccination (Groups 4-6). Assessments like immunogenicity (such as humoral and cellular immune responses), safety and reactogenicity (such as adverse events [AEs] monitoring) will be performed in this study. Other safety assessments include vital signs measurements (heart rate, supine systolic and diastolic blood pressure, respiratory rate, and body temperature) and physical examinations. The overall study duration from enrolment of the first participant until study completion is expected to be up to 1 year 11 months.

Official Title
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A Randomized, Observer-blind, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S Administered as a One- or Two-dose Regimen in Healthy Adolescents From 12 to 17 Years Inclusive

Conditions
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Coronavirus Disease-2019 (COVID-19) Prevention

Intervention / Treatment
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* Biological: Ad26.COV2.S


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant's age is 12 to 17 years of age at the time of first vaccination Participant must be healthy, in the investigator's clinical judgement, 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) 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 and/or parent(s)/legal guardian(s) are available and willing to participate for the duration of the study visits and follow-up Each participant or participant's parent(s)/legal guardian(s) must have access to a consistent means of contact either by telephone contact or email/computer Exclusion Criteria: Participant has a history of malignancy, bone marrow transplant, or solid organ transplant within 5 years before screening Participant has a known or suspected allergy, history of anaphylaxis, or other serious adverse reactions, related to vaccines or their excipients (including specifically the excipients of the study vaccine) Use of systemic corticosteroids at an immunosuppressive dose (treatment duration more than 14 days for one course or recurrent use) within 6 months before administration of study vaccine and during the study 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 Any serious, chronic, or progressive disease (example: diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, acquired immunodeficiency syndrome [AIDS] infection, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure, or severe malnutrition)

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Ad26.COV2.S Dose Level 1 (Lower Volume): 1-Dose Regimen<br>Participants will receive 1-dose of Ad26.COV2.S at dose level 1 on Day 1 and placebo on Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants will receive booster vaccination at dose level 1 on Day 184. | Biological: Ad26.COV2.S<br>* Ad26.COV2.S will be administered as intramuscular (IM) injection.<br>* Other names: Ad26COVS1, VAC31518, JNJ-78436735;|
| Experimental: Group 2: Ad26.COV2.S Dose Level 2: 1-Dose Regimen<br>Participants will receive 1-dose of Ad26.COV2.S at dose level 2 on Day 1 and placebo on Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants will receive booster vaccination at dose level 1 on Day 184. | Biological: Ad26.COV2.S<br>* Ad26.COV2.S will be administered as intramuscular (IM) injection.<br>* Other names: Ad26COVS1, VAC31518, JNJ-78436735;|
| Experimental: Group 3: Ad26.COV2.S Dose Level 3: 1-Dose Regimen<br>Participants will receive 1-dose of Ad26.COV2.S at dose level 3 on Day 1 and placebo on Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants will receive booster vaccination at dose level 1 on Day 184. | Biological: Ad26.COV2.S<br>* Ad26.COV2.S will be administered as intramuscular (IM) injection.<br>* Other names: Ad26COVS1, VAC31518, JNJ-78436735;|
| Experimental: Group 4: Ad26.COV2.S Dose Level 1: 2-Dose Regimen<br>Participants will receive 2-dose of Ad26.COV2.S at dose level 1 on Day 1 and 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. | Biological: Ad26.COV2.S<br>* Ad26.COV2.S will be administered as intramuscular (IM) injection.<br>* Other names: Ad26COVS1, VAC31518, JNJ-78436735;|
| Experimental: Group 5: Ad26.COV2.S Dose Level 2: 2-Dose Regimen<br>Participants will receive 2-doses of Ad26.COV2.S at dose level 2 on Day 1 and Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. | Biological: Ad26.COV2.S<br>* Ad26.COV2.S will be administered as intramuscular (IM) injection.<br>* Other names: Ad26COVS1, VAC31518, JNJ-78436735;|
| Experimental: Group 6: Ad26.COV2.S Dose Level 3: 2-Dose Regimen<br>Participants will receive 2-doses of Ad26.COV2.S at dose level 3 on Day 1 and Day 57. Participants will be unblinded to the primary vaccination regimen at 6 months after the first vaccination. | Biological: Ad26.COV2.S<br>* Ad26.COV2.S will be administered as intramuscular (IM) injection.<br>* Other names: Ad26COVS1, VAC31518, JNJ-78436735;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Solicited Local Adverse Events (AEs) 7 Days Post-dose 1 | An AE is 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 are pre-defined local (at the injection site) AEs for which participants are specifically asked and which are noted by participants in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site. | 7 days post-dose 1 (Day 8) | 
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Solicited Local Adverse Events (AEs) 7 Days Post-dose 2 | An AE is 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 are pre-defined local (at the injection site) AEs for which participants are specifically asked and which are noted by participants in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site. | 7 days post-dose 2 (Day 64) | 
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Solicited Systemic AEs 7 Days Post-dose 1 | Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, and myalgia. | 7 days post-dose 1 (Day 8) | 
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Solicited Systemic AEs 7 Days Post-dose 2 | Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for following solicited systemic AEs: fatigue, headache, nausea, and myalgia. | 7 days post-dose 2 (Day 64) | 
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Unsolicited AEs 28 Days Post-dose 1 | Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary. | 28 days post-dose 1 (Day 29) | 
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Unsolicited AEs 28 Days Post-dose 2 | Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary. | 28 days post-dose 2 (Day 85) | 
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Medically-attended Adverse Events (MAAEs) | MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs. | From the first vaccination until 6 months post-dose 1 (Up to Day 184) | 
| Groups 1, 2, 3, 4, 5 and 6: Number of Participants with MAAEs | MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs. | From the first vaccination until 6 months post-dose 2 (Up to Day 240) | 
| Groups 1, 2 and 3: Number of Participants with MAAEs Leading to Discontinuation | MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs. | Up to Day 366 (6 months after booster vaccination on Day 184) | 
| Groups 4, 5 and 6: Number of Participants with MAAEs Leading to Discontinuation | MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs. | Up to Day 240 (6 months after second vaccination on Day 57) | 
| Groups 1, 2 and 3: Number of Participants with Serious Adverse Events (SAEs) | SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. | Up to Day 366 (6 months after booster vaccination on Day 184) | 
| Groups 4, 5 and 6: Number of Participants with SAEs | SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. | Up to Day 240 (6 months after second vaccination on Day 57) | 
| Groups 1, 2 and 3: Number of Participants with Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C]) | Number of participants with AESI (including MIS-C) will be reported. Thrombosis with thrombocytopenia syndrome (TTS) and MIS-C are considered to be AESIs. | Up to Day 366 (6 months after booster vaccination on Day 184) | 
| Groups 4, 5 and 6: Number of Participants with AESI (Including MIS-C) | Number of participants with AESI (including MIS-C) will be reported. Thrombosis with TTS and MIS-C are considered to be AESIs. | Up to Day 240 (6 months after second vaccination on Day 57) | 
| Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Spike-enzyme-linked Immunosorbent Assay (S-ELISA) or Equivalent Assay 28 Days Post-dose 1 | Serological response to vaccination will be measured by S-ELISA (ELISA Units/mL [EU/mL]) or equivalent assay 28 days post-dose 1. | 28 days post-dose 1 (Day 29) | 
| Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA or Equivalent Assay 14 Days Post-dose 2 | Serological response to vaccination will be measured by S-ELISA (ELISA Units/mL [EU/mL]) or equivalent assay 14 days post-dose 2. | 14 days post-dose 2 (Day 71) | 
| Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1 | Serological response to vaccination will be measured by VNA titers 28 days post-dose 1. | 28 days post-dose 1 (Day 29) | 
| Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2 | Serological response to vaccination will be measured by VNA titers 14 days post-dose 2. | 14 days post-dose 2 (Day 71) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or individual SARS-CoV-2 S Proteins as Assessed by ELISA (or Equivalent Assay). | Serological response to vaccination measured by binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 S proteins as assessed by ELISA (or equivalent assay) will be reported. | Groups 1-3: Days 1, 29, 57, 71, 184, 198, and 366; Groups 4-6: Days 1, 29, 57, 71 and 240 | 
| Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 | Serological response to vaccination measured by neutralizing antibody titers to SARS-CoV-2 (VNA) will be reported. | Groups 1-3: Days 1, 29, 57, 71, 184, 198 and 366; Groups 4-6: Days 1, 29, 57, 71 and 240 | 
| Groups 1, 2 and 3: Number of Participants with Solicited Local AEs for 7 Days Post-booster Vaccination | Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically asked and which are noted by participants in their reactogenicity diary for 7 days post booster vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination. | Up to Day 191 (7 days after booster vaccination on Day 184) | 
| Groups 1, 2 and 3: Number of Participants with Solicited Systemic AEs for 7 Days Post-booster Vaccination | Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, and myalgia. | Up to Day 191 (7 days after booster vaccination on Day 184) | 
| Groups 1, 2 and 3: Number of Participants with Unsolicited AEs for 28 Days Post-booster Vaccination | Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary. | Up to Day 212 (28 days after booster Vaccination on Day 184) | 
| Groups 1, 2 and 3: Number of Participants with MAAEs Until 6 Months Post-booster Vaccination | MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs. | Up to Day 366 (6 months after booster vaccination on Day 184) | 
| Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA and/or Equivalent Assay) Antibody Titers | Serological response to vaccination measured by binding (S-ELISA and/or equivalent assay) antibody titers will be reported. | Days 184, 198 and 366 | 
| Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers | Serological response to vaccination measured by neutralizing (VNA) antibody titers will be reported. | Days 184, 198 and 366 |