Clinical trial
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
Name
CR108966
Description
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.
Trial arms
Trial start
2021-09-27
Estimated PCD
2023-08-14
Trial end
2023-08-14
Status
Completed
Phase
Early phase I
Treatment
Ad26.COV2.S
Ad26.COV2.S will be administered as intramuscular (IM) injection.
Arms:
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
Other names:
Ad26COVS1, VAC31518, JNJ-78436735
Size
304
Primary endpoint
Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Solicited Local Adverse Events (AEs) 7 Days Post-dose 1
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
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
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
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
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
28 days post-dose 2 (Day 85)
Groups 1, 2, 3, 4, 5 and 6: Number of Participants with Medically-attended Adverse Events (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
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
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
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)
Up to Day 366 (6 months after booster vaccination on Day 184)
Groups 4, 5 and 6: Number of Participants with SAEs
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])
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)
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
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
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
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
14 days post-dose 2 (Day 71)
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 304, 'type': 'ACTUAL'}}
Updated at
2023-10-13
1 organization
1 product
1 indication
Organization
Janssen Vaccines & PreventionProduct
Ad26.COV2.SIndication
COVID-19