Phase 2
Completed N=300
A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive
Coronavirus Disease-2019 (COVID-19) Prevention
Source: ClinicalTrials.gov NCT05007080 ↗
Enrolled (actual)
300
Serious AEs
1.0%
Results posted
May 2024
Primary outcomePrimary: Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1 — 13; 16; 17; 11 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1 |
13; 16; 17; 11; 12; 15 | — |
| PRIMARY Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2 |
8; 10; 3; 16; 9; 10 | — |
| PRIMARY Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 1 |
20; 13; 18; 14; 16; 16 | — |
| PRIMARY Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 2 |
11; 10; 4; 14; 10; 11 | — |
| PRIMARY Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 1 |
9; 9; 5; 3; 8; 10 | — |
| PRIMARY Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 2 |
7; 7; 8; 7; 7; 9 | — |
| PRIMARY Groups 1, 2, 3, 4, and 5: Number of Participants With Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1 |
2; 0; 0; 1; 0; 5 | — |
| PRIMARY Groups 1, 2, 3, 4, 5 and 6: Number of Participants With MAAEs 6 Months Post-Dose 2 |
4; 6; 2; 2; 4; 5 | — |
| PRIMARY Groups 1, 2, and 3: Number of Participants With MAAEs Leading to Discontinuation |
0; 0; 0 | — |
| PRIMARY Groups 4, 5 and 6: Number of Participants With MAAEs Leading to Discontinuation |
0; 0; 0 | — |
| PRIMARY Groups 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs) |
1; 1; 0 | — |
| PRIMARY Groups 4, 5 and 6: Number of Participants With Serious Adverse Events (SAEs) |
0; 1; 0 | — |
| PRIMARY Groups 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C]) |
0; 0; 0 | — |
| PRIMARY Groups 4, 5 and 6: Number of Participants With AESI (Including MIS-C) |
0; 0; 0 | — |
| PRIMARY 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 |
6533; 7812; 5881; 9273; 6758; 6069 | — |
| PRIMARY Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2 |
4923; 4679; 4043; 8958; 8716; 6522 | — |
| PRIMARY Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1 |
1325; 1754; 1392; 2038; 1878; 1455 | — |
| PRIMARY Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2 |
1187; 1094; 864; 2386; 2670; 1742 | — |
| SECONDARY 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 |
255; 297; 338; 256; 200; 282 | — |
| SECONDARY Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2 |
105; 149; 114; 112; 83; 127 | — |
| SECONDARY Groups 1, 2 and 3: Number of Participants With Solicited Local AEs for 7 Days Post-booster Vaccination |
19; 16; 17 | — |
| SECONDARY Groups 1, 2 and 3: Number of Participants With Solicited Systemic AEs for 7 Days Post-booster Vaccination |
16; 14; 15 | — |
| SECONDARY Groups 1, 2 and 3: Number of Participants With Unsolicited AEs for 28 Days Post-booster Vaccination |
6; 8; 10 | — |
| SECONDARY Groups 1, 2 and 3: Number of Participants With MAAEs Until 6 Months Post-booster Vaccination |
1; 2; 2 | — |
| SECONDARY Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers |
4131; 4765; 3861; 6782; 7656; 10506 | — |
| SECONDARY Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers |
1358; 1702; 860; 2496; 2547; 4083 | — |
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)
Data sourced from ClinicalTrials.gov (NCT05007080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.