Clinical trial NCT05007080: A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronavirus Disease-2019 (COVID-19) Prevention
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2021-08-16
Enrollment: 304
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1
timeFrame: 7 days post-dose 1 on Day 1 (Day 8)
measure: Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2
timeFrame: 7 days post-dose 2 on Day 57 (Day 64)
measure: Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 1
timeFrame: 7 days post-dose 1 on Day 1 (Day 8)
measure: Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 2
timeFrame: 7 days post-dose 2 on Day 57 (Day 64)
measure: Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 1
timeFrame: 28 days post-dose 1 on Day 1 (Day 29)
measure: Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 2
timeFrame: 28 days post-dose 2 on Day 57 (Day 85)
measure: Groups 1, 2, 3, 4, and 5: Number of Participants With Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1
timeFrame: From the first vaccination (Day 1) until 6 months post-dose 1 on Day 1 (Up to Day 184)
measure: Groups 1, 2, 3, 4, 5 and 6: Number of Participants With MAAEs 6 Months Post-Dose 2
timeFrame: From the first vaccination (Day 1) until 6 months post-dose 2 on Day 57 (Up to Day 240)
measure: Groups 1, 2, and 3: Number of Participants With MAAEs Leading to Discontinuation
timeFrame: From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)
measure: Groups 4, 5 and 6: Number of Participants With MAAEs Leading to Discontinuation
timeFrame: From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57)
measure: Groups 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)
measure: Groups 4, 5 and 6: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57)
measure: Groups 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C])
timeFrame: From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)
measure: Groups 4, 5 and 6: Number of Participants With AESI (Including MIS-C)
timeFrame: From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57)
measure: 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
timeFrame: 28 days post-dose 1 on Day 1 (Day 29)
measure: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2
timeFrame: 14 days post-dose 2 on Day 57 (Day 71)
measure: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1
timeFrame: 28 days post-dose 1 on Day 1 (Day 29)
measure: Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2
timeFrame: 14 days post-dose 2 on Day 57 (Day 71)
Secondary outcomes:
measure: 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
timeFrame: Groups 1-3: Days 1, 29, 57, 71, 184, 198, and 366; Groups 4-6: Days 1, 29, 57, 71 and 240
measure: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2
timeFrame: Groups 1-3: Days 1, 29, 57, 71, 184, 198 and 366; Groups 4-6: Days 1, 29, 57, 71 and 240
measure: Groups 1, 2 and 3: Number of Participants With Solicited Local AEs for 7 Days Post-booster Vaccination
timeFrame: From first vaccination on Day 1 up to Day 191 (7 days after booster vaccination on Day 184)
measure: Groups 1, 2 and 3: Number of Participants With Solicited Systemic AEs for 7 Days Post-booster Vaccination
timeFrame: From first vaccination on Day 1 up to Day 191 (7 days after booster vaccination on Day 184)
measure: Groups 1, 2 and 3: Number of Participants With Unsolicited AEs for 28 Days Post-booster Vaccination
timeFrame: From first vaccination on Day 1 up to Day 212 (28 days after booster Vaccination on Day 184)
measure: Groups 1, 2 and 3: Number of Participants With MAAEs Until 6 Months Post-booster Vaccination
timeFrame: From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)
measure: Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers
timeFrame: Days 184, 198 and 366
measure: Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers
timeFrame: Days 184, 198 and 366
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: CIPREC
city: Córdoba
country: Argentina
facility: Hospital de Ninos de Cordoba
city: San Miguel de Tucumán
country: Argentina
facility: Hospital del Niño Jesús
city: Belo Horizonte
country: Brazil
facility: Universidade Federal De Minas Gerais - Hospital das Clínicas
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
city: Ribeirão Preto
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica LTDA ME
city: Chennai
country: India
facility: Sri ramchandra Medical College & Research Institute
city: Mysore
country: India
facility: JSS Hospital
city: Nashik
country: India
facility: Supe Heart And Diabetes Hospital and Research Center
city: Surat
country: India
facility: BAPS Pramukhswami Hospital
city: Ciudad de Mexico
country: Mexico
facility: CAIMED Investigacion en salud S.A de C.V.
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
city: Dennilton
country: South Africa
facility: Ndlovu Elandsdoorn Site
city: Johannesburg
country: South Africa
facility: Shandukani Research Centre
city: Soshanguve
country: South Africa
facility: Setshaba Research Centre
city: Soweto
country: South Africa
facility: Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
city: Westdene Johannesburg Gauteng
country: South Africa
facility: University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: