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

NCT05007080 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR1089662020-005720-11VAC31518COV3006
• Study Type: interventional
• Target: 304
• Locations: 5 countries
• Sites: 18

Brief Summary

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.

Conditions

Coronavirus Disease-2019 (COVID-19) Prevention

Outcome Measures

Primary Outcomes (18)

• Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 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 AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were 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 on Day 1 (Day 8)

• Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 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 AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, swelling at the vaccination site.

  7 days post-dose 2 on Day 57 (Day 64)

• Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 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 AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AES for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Participants were 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, myalgia and pyrexia.

  7 days post-dose 1 on Day 1 (Day 8)

• Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 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 AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AES for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Participants were 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, myalgia and pyrexia.

  7 days post-dose 2 on Day 57 (Day 64)

• Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 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 AEs that started within 7 days after vaccination but were ongoing after this 7-day window after each vaccination are also considered unsolicited AEs. Unsolicited AEs were defined as AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.

  28 days post-dose 1 on Day 1 (Day 29)

• Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 2

  Description: 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 AEs that started within 7 days after vaccination but were ongoing after this 7-day window after each vaccination are also considered unsolicited AEs. Unsolicited AEs were defined as AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.

  28 days post-dose 2 on Day 57 (Day 85)

• Groups 1, 2, 3, 4, and 5: Number of Participants With Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1

  MAAEs were 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 were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs.

  From the first vaccination (Day 1) until 6 months post-dose 1 on Day 1 (Up to Day 184)

• Groups 1, 2, 3, 4, 5 and 6: Number of Participants With MAAEs 6 Months Post-Dose 2

  MAAEs were 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 were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs.

  From the first vaccination (Day 1) until 6 months post-dose 2 on Day 57 (Up to Day 240)

• Groups 1, 2, and 3: Number of Participants With MAAEs Leading to Discontinuation

  Number of participants with MAAEs leading to discontinuation were reported. MAAEs were 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 were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs.

  From first vaccination on Day 1 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

  Number of participants with MAAEs leading to discontinuation were reported. MAAEs were 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 were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs.

  From first vaccination on Day 1 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 were defined as 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.

  From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)

• Groups 4, 5 and 6: Number of Participants With Serious Adverse Events (SAEs)

  SAE were defined as 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.

  From first vaccination on Day 1 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) were reported. Thrombotic events (suspected deep vessel venous or arterial thrombotic events); Thrombocytopenia (platelet count below 150,000/μL) and MIS-C (a subject \<21 years with fever, evidence of inflammation, and evidence of clinically severe illness requiring hospitalization, with multisystem (≥2) organ involvement \[cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological\]; \& No alternative diagnoses; \& Positive for ositive for current or recent (SARS-CoV-2) coronavirus disease 2019 \[COVID-19\] infection by Real-time reverse transcriptase-polymerase chain reaction \[RT-PCR\], serology, or antigen test; Or COVID-19 exposure within the 4 weeks prior to the onset of symptoms) were considered AESIs in this study.

  From first vaccination on Day 1 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) were reported. Thrombotic events: suspected deep vessel venous or arterial thrombotic events and Thrombocytopenia, defined as platelet count below 150,000/μL and MIS-C were considered as AESIs in this study. MIS-C, defined as: An individual aged \<21 years presenting with fever, laboratory evidence of inflammation, and evidence of clinically severe illness requiring hospitalization, with multisystem (≥2) organ involvement (cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic,or neurological); AND No alternative plausible diagnoses; AND Positive for current or recent SARS-CoV-2 (COVID-19) infection by RT-PCR, serology, or antigen test; or COVID-19 exposure within the 4 weeks prior to the onset of symptoms.

  From first vaccination on Day 1 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) at 28 Days Post-dose 1

  Serological response to vaccination measured by S-ELISA (ELISA Unit/milliliter (EU/mL)) at 28 days post-dose 1 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of less than or equal to the lower limit of quantification (\<=LLOQ) and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly \>LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported.

  28 days post-dose 1 on Day 1 (Day 29)

• Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2

  Serological response to vaccination measured by S-ELISA (EU/mL) at 14 days post-dose 2 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of \<=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly \>LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported.

  14 days post-dose 2 on Day 57 (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 measured by VNA titers at 28 days post-dose 1 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of \<=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly \>LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data were expressed as 50 percent (%) inhibitory concentration (IC50) units.

  28 days post-dose 1 on Day 1 (Day 29)

• Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2

  Serological response to vaccination measured by VNA titers 14 days post-dose 2 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of \<=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly \>LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data were expressed as IC50 units.

  14 days post-dose 2 on Day 57 (Day 71)

Secondary Outcomes (8)

• 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

  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

  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

  From first vaccination on Day 1 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

  From first vaccination on Day 1 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

  From first vaccination on Day 1 up to Day 212 (28 days after booster Vaccination on Day 184)

Study Arms (6)

Group 1: Ad26.COV2.S Dose Level 1 (Lower Volume): 1-Dose Regimen

EXPERIMENTAL

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

Group 2: Ad26.COV2.S Dose Level 2: 1-Dose Regimen

EXPERIMENTAL

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

Group 3: Ad26.COV2.S Dose Level 3: 1-Dose Regimen

EXPERIMENTAL

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

Group 4: Ad26.COV2.S Dose Level 1: 2-Dose Regimen

EXPERIMENTAL

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

Group 5: Ad26.COV2.S Dose Level 2: 2-Dose Regimen

EXPERIMENTAL

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

Group 6: Ad26.COV2.S Dose Level 3: 2-Dose Regimen

EXPERIMENTAL

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

Interventions

Ad26.COV2.S BIOLOGICAL

Ad26.COV2.S will be administered as intramuscular (IM) injection.

Also known as: Ad26COVS1, VAC31518, JNJ-78436735

Group 1: Ad26.COV2.S Dose Level 1 (Lower Volume): 1-Dose Regimen; Group 2: Ad26.COV2.S Dose Level 2: 1-Dose Regimen; Group 3: Ad26.COV2.S Dose Level 3: 1-Dose Regimen; Group 4: Ad26.COV2.S Dose Level 1: 2-Dose Regimen; Group 5: Ad26.COV2.S Dose Level 2: 2-Dose Regimen; Group 6: Ad26.COV2.S Dose Level 3: 2-Dose Regimen

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (18)

CIPREC

Buenos Aires, C1119ACN, Argentina

Location

Hospital de Ninos de Cordoba

Córdoba, 5000, Argentina

Location

Hospital del Niño Jesús

San Miguel de Tucumán, 4000, Argentina

Location

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, 30130-100, Brazil

Location

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, 30150-221, Brazil

Location

Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

Ribeirão Preto, 14051-140, Brazil

Location

CPQuali Pesquisa Clinica LTDA ME

São Paulo, 01228-000, Brazil

Location

Sri ramchandra Medical College & Research Institute

Chennai, 600116, India

Location

JSS Hospital

Mysore, 570004, India

Location

Supe Heart And Diabetes Hospital and Research Center

Nashik, 0422002, India

Location

BAPS Pramukhswami Hospital

Surat, 395009, India

Location

CAIMED Investigacion en salud S.A de C.V.

Mexico City, 06760, Mexico

Location

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, 64460, Mexico

Location

Ndlovu Elandsdoorn Site

Dennilton, 0485, South Africa

Location

Shandukani Research Centre

Johannesburg, 2001, South Africa

Location

Setshaba Research Centre

Soshanguve, 152, South Africa

Location

Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital

Soweto, 1864, South Africa

Location

University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre

Westdene Johannesburg Gauteng, 2092, South Africa

Location

Related Publications (1)

• Tica J, Rezelj VV, Baron B, van Paassen V, Zaidman J, Fairlie L, Scheper G, Le Gars M, Struyf F, Douoguih M, Ruiz-Guinazu J; COV3006 study group; COV3006 Study Group Collaborators. Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trial. Hum Vaccin Immunother. 2025 Dec;21(1):2450120. doi: 10.1080/21645515.2025.2450120. Epub 2025 Jan 27.

  PMID: 39868766 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Ad26COVS1

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Clinical Franchise Leader
• Organization: Janssen Vaccines & Prevention B.V.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 16, 2021
• Study Start: September 27, 2021
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: February 4, 2025
• Results First Posted: May 23, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

IN (4); AR (3); ME (2); ZA (5); BR (4)