Phase 2
Completed N=617
A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults and Adolescents
Healthy
Source: ClinicalTrials.gov NCT04535453 ↗
Enrolled (actual)
617
Serious AEs
2.1%
Results posted
Jun 2023
Primary outcomePrimary: Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers at 28 Days After Vaccination 2 — 96.8; 100.0; 88.9 Percentage of participants
Summary
The primary purpose of this study is to assess humoral immune responses of 3 dose levels of Ad26.COV2.S administered intramuscularly (IM) as a 2-dose schedule (56 days apart); Ad26.COV2.S administered IM as a single vaccination; safety and reactogenicity of Ad26.COV2.S administered IM as a 2-dose or a single-dose schedule in adults (18-65 years or older) and to assess the safety and reactogenicity of Ad26.COV2.S, administered IM as single dose in adolescents (12-17 years) and to test both compressed and expanded 2-dose schedules of Ad26.COV2.S (28 and 84 days apart) in adults (18-55 years and 65 years or older).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers at 28 Days After Vaccination 2 |
96.8; 100.0; 88.9 | — |
| PRIMARY Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Spike Binding Antibodies Enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days After Vaccination 2 |
100.0; 100.0; 96.7 | — |
| PRIMARY Adults of Groups 1, 2 and 3: Antibody Geometric Mean Titers (GMTs) as Measured by VNA at 28 Days After Vaccination 2 |
455; 490; 364 | — |
| PRIMARY Adults of Groups 1, 2 and 3: Antibody Geometric Mean Concentrations (GMCs) as Measured by (S-ELISA) at 28 Days After Vaccination 2 |
1742; 1563; 1130 | — |
| PRIMARY Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers at 28 Days After Vaccination 1 |
97.3; 100.0; 0.0 | — |
| PRIMARY Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 1 |
98.5; 95.4; 0.0 | — |
| PRIMARY Adults of Groups 4, 5 and 6: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1 |
263; 253; NA | — |
| PRIMARY Adults of Groups 4, 5 and 6: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1 |
505; 360; NA | — |
| PRIMARY Adults of Groups 9 and 10: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 2 |
100.0; 15.4 | — |
| PRIMARY Adults of Groups 9 and 10: Percentage of Participant With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 2 |
100.0; 4.3 | — |
| PRIMARY Adults of Groups 9 and 10: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 2 |
901; NA | — |
| PRIMARY Adults of Groups 9 and 10: Antibody GMCs as Measured by S-ELISA at 28 Days After Vaccination 2 |
2391; NA | — |
| PRIMARY Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1 |
27; 24; 39; 42; 21; 2 | — |
| PRIMARY Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 |
35; 31; 56; 50; 32; 10 | — |
| PRIMARY Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 2 |
33; 29; 5; 4; 20; 2 | — |
| PRIMARY Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 2 |
32; 25; 24; 20; 26; 6 | — |
| PRIMARY Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1 |
25; 15; 33; 30; 8; 5 | — |
| PRIMARY Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 2 |
17; 15; 16; 22; 10; 4 | — |
| PRIMARY Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Serious Adverse Events (SAEs) |
1; 1; 1; 2; 1; 0 | — |
| PRIMARY Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Adverse Events of Special Interest (AESIs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Adolescents: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 1 |
29; 1 | — |
| PRIMARY Adolescents: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 1 |
28; 3 | — |
| PRIMARY Adolescents: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1 |
12; 2 | — |
| PRIMARY Adolescents: Number of Participants With SAEs (Inclusive Multisystem Inflammatory Syndrome in Children [MIS-C]) |
0; 0 | — |
| PRIMARY Adolescents: Number of Participants With AESIs |
0; 0 | — |
| SECONDARY Adults of Groups 1 to 5, Groups 7 and 9: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation |
92.0; 97.0; 83.9; 84.8; 96.3; 100.0 | — |
| SECONDARY Adults of Groups 1 to 5, Groups 7 and 9: GMTs as Measured by VNA 7 Days After Antigen Presentation |
318; 393; 279; 275; 525; 616 | — |
| SECONDARY Adults of Groups 1 to 5 and Group 9: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation |
100.0; 100.0; 96.5; 100.0; 91.2; 100.0 | — |
| SECONDARY Adults of Group 7: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation |
96.8 | — |
| SECONDARY Adults of Groups 1 to 5 and Group 9: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation |
1146; 1179; 1038; 1024; 1262; 1963 | — |
| SECONDARY Adults of Group 7: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation |
1141 | — |
| SECONDARY Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Antigen Presentation |
28; 29; 31; 35; 16; 2 | — |
| SECONDARY Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Antigen Presentation |
30; 24; 23; 28; 15; 4 | — |
| SECONDARY Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Antigen Presentation |
10; 7; 6; 12; 6; 4 | — |
| SECONDARY Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With SAEs After Antigen Presentation |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With AESIs After Antigen Presentation |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA |
100.0; 100.0; 96.6; 96.8; 80.8; 0.0 | — |
| SECONDARY Adults Group 9 and 10: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA |
100.0; 0.0; 100.0; 0.0 | — |
| SECONDARY Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins |
100.0; 100.0; 98.2; 100.0; 98.2; 0.0 | — |
| SECONDARY Adults of Groups 9 and 10: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins |
100.0; 0.0; 97.4; 0.0 | — |
| SECONDARY Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 1 (Day 29) |
100.0; 0.0 | — |
| SECONDARY Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 28 Days After Vaccination 1 (Day 29) |
100.0; 0.0 | — |
| SECONDARY Adolescents: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1 |
305; NA | — |
| SECONDARY Adolescents: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1 |
682; NA | — |
| SECONDARY Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA |
323; NA; 306; NA; 342 | — |
| SECONDARY Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA |
770; NA; 773; NA; 796 | — |
| SECONDARY Adults: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation |
100.0; 100.0; 96.5; 100.0; 91.2; 100.0 | — |
Eligibility Criteria
Inclusion Criteria
For Adults
- Participant must have a body mass index (BMI) less than ( =) 38.0 degree Celsius [C] (100.4 degree Fahrenheit [F]) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
- Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
- Participant received treatment with immunoglobulins in the 3 months or blood products in the 4 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study
- Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational Ig or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine (including investigational Adenoviral-vectored vaccines) within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study For Adolescents
- Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
- 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
- Participant has a history of Kawasaki disease
- Participant has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Data sourced from ClinicalTrials.gov (NCT04535453). 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.