Phase 3
Completed N=44,324
A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants
Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol
Source: ClinicalTrials.gov NCT04505722 ↗
Enrolled (actual)
44,324
Serious AEs
3.8%
Results posted
Apr 2022
Primary outcomePrimary: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status With Onset at Least 14 Days After Double-blind Vaccination on Day 1 (Day 15): Double-blind Phase — 381; 847; 103; 220 Participants
◆ Published Evidence
Highly cited
250citations · ~63 / year
Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S.
Summary
The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.
Linked Publications (5)
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Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S.
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Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial.
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Neutralizing antibody correlate of protection against severe-critical COVID-19 in the ENSEMBLE single-dose Ad26.COV2.S vaccine efficacy trial.
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Association Between SARS-CoV-2 Viral Load and COVID-19 Vaccination in 4 Phase 3 Trials.
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Modifiers of COVID-19 vaccine efficacy: Results from four COVID-19 prevention network efficacy trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status With Onset at Least 14 Days After Double-blind Vaccination on Day 1 (Day 15): Double-blind Phase |
381; 847; 103; 220 | — |
| PRIMARY Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status With Onset at Least 28 Days After Double-blind Vaccination on Day 1 (Day 29): Double-blind Phase |
340; 716; 93; 167; 433; 883 | — |
| PRIMARY Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase) |
3758; 135; 204 | — |
| PRIMARY Number of Participants With Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase) |
3559; 145; 198 | — |
| PRIMARY Number of Participants With Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase) |
2133; 58; 95 | — |
| SECONDARY Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status With Onset at Least 14 Days After Double-blind Vaccination on Day 1 (Day 15): Double-blind Phase |
56; 205 | — |
| SECONDARY Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status With Onset at Least 28 Days After Double-blind Vaccination on Day 1 (Day 29): Double-blind Phase |
46; 176 | — |
| SECONDARY Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase) |
436; 895 | — |
| SECONDARY Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase) |
436; 895 | — |
| SECONDARY Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase) |
436; 895 | — |
| SECONDARY Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Double Blind Phase) |
16; 64 | — |
| SECONDARY Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Double Blind Phase) |
16; 64 | — |
| SECONDARY Area Under the Curve (AUC) of SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants With Molecularly Confirmed, Moderate to Severe/Critical COVID-19 (Double Blind Phase) |
823.7; 921.47 | — |
| SECONDARY Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Double Blind Phase |
11; 15 | — |
| SECONDARY Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Double Blind Phase) |
10; 12 | — |
| SECONDARY Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Double Blind Phase) |
441; 884 | — |
| SECONDARY Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Double Blind Phase) |
441; 884 | — |
| SECONDARY Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Double Blind Phase) |
495; 1082 | — |
| SECONDARY Number of Participants With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Double Blind Phase) |
443; 895 | — |
| SECONDARY Number of Participants With SARS-CoV-2 Seroconversion Based on Antibodies to N Protein Using ELISA and/or SARS-CoV-2 Immunoglobulin Assay (Double Blind Phase) |
550; 724 | — |
| SECONDARY Number of Participants With Asymptomatic Infection Detected by RT-PCR at the Time of the Month 6/Unblinding Visit (Double Blind Phase) |
10; 12 | — |
| SECONDARY Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) (Double Blind Phase) |
1038; 1699 | — |
| SECONDARY Number of Participants With First Occurrence of Molecularly Confirmed, Moderate to Severe/Critical COVID-19 for Seronegative Participants (Double Blind Phase) |
575; 1189 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) (Double Blind Phase) |
235; 358 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interest (AESI) (Double Blind Phase) |
6; 5 | — |
| SECONDARY Number of Participants With Medically-Attended Adverse Events (MAAEs) (Double Blind Phase) |
1672; 1885 | — |
| SECONDARY Number of Participants With MAAEs Leading to Study Discontinuation (Double Blind Phase) |
1; 2 | — |
| SECONDARY Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination (Double Blind Phase) |
1839; 684 | — |
| SECONDARY Number of Participants With Solicited Systemic AEs During 7 Days Following Vaccination (Double Blind Phase) |
2021; 1307 | — |
| SECONDARY Number of Participants With Unsolicited AEs During 28 Days Post-vaccination (Double Blind Phase) |
456; 422 | — |
| SECONDARY Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Double Blind Phase) |
NA; NA; 336; NA; 526; NA | — |
| SECONDARY Number of Participants With Antibody Titers to Ad26.COV2.S (Booster Phase) |
— | — |
| SECONDARY Number of Participants With Binding Antibodies to SARS- CoV-2S Protein as Measured by ELISA (Booster Phase) |
64; 26; 9; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
- All participants of childbearing potential must: have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration
- 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
- Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
- Must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the coronavirus disease-2019 [COVID 19] signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs). Note: Participants with visual impairment are eligible for study participation and may have caregiver assistance in completing the electronic clinical outcome assessment (eCOA) questionnaires
Exclusion Criteria
- Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (100.4-degree Fahrenheit) 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 received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine ; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine
- Participant previously received a coronavirus vaccine
- Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) within 30 days or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (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
Data sourced from ClinicalTrials.gov (NCT04505722) and the linked publication. 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.