A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 5 February 2024
• Main ID: NCT04505722
• Date of registration: 31/07/2020
• Prospective Registration: Yes
• Primary sponsor: Janssen Vaccines & Prevention B.V.
• Public title: A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants ENSEMBLE
• Scientific title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older
• Date of first enrolment: September 7, 2020
• Target sample size: 44325
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04505722
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, South Africa, Ukraine, United States

Contacts

• Name: Janssen Vaccines & Prevention B.V. Clinical Trial
• Affiliation: Janssen Vaccines & Prevention B.V.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol

Intervention(s)

Other: Placebo

Biological: Ad26.COV2.S

Primary Outcome(s)

Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase) [Time Frame: 28 Days after unblinding visit to 1 year follow up of the last booster vaccination (up to Day 560)]

Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status (Main Study) [Time Frame: 28 Days after double-blind vaccination (Day 29)]

Number of Participants With Adverse Events of Special Interest (AESI) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase) [Time Frame: From booster vaccination (Year 1) up to end of the study (up to 2 years 3 months)]

Number of Participants With Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase) [Time Frame: Up to Day 393 (28 Days after booster vaccination on Day 365 [Year 1])]

Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase) [Time Frame: 14 days after booster vaccination (Day 379) to end of study (up to 2 years and 3 month)]

Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Main Study) [Time Frame: 14 Days after double-blind vaccination (Day 15)]

Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase) [Time Frame: 14 Days after unblinding visit to 1 year follow up of the last booster vaccination (up to Day 546)]

Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase) [Time Frame: 28 days after booster vaccination (Day 393) to end of study (up to 2 years and 3 month)]

Number of Participants With Serious Adverse Events (SAEs) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase) [Time Frame: From booster vaccination (Year 1) up to end of the study (up to 2 years 3 months)]

Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase) [Time Frame: Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])]

Number of Participants With Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase) [Time Frame: Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])]

Secondary Outcome(s)

Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Main Study) [Time Frame: Baseline (Day 1), Day 29, and Day 71]

Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study) [Time Frame: 14 days after double-blind vaccination (Day 15)]

Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study) [Time Frame: 28 Days after double-blind vaccination (Day 29)]

Number of Participants With MAAEs Leading to Study Discontinuation (Main Study) [Time Frame: Up to 35 weeks]

Number of Participants With Solicited Systemic AEs During 7 Days Following Vaccination (Main Study) [Time Frame: Up to Day 8 (7 Days after double-blind vaccination on Day 1)]

Number of Participants With Serious Adverse Events (SAEs) (Main Study) [Time Frame: Up to 35 weeks]

Number of Participants With Unsolicited AEs During 28 Days Post-vaccination (Main Study) [Time Frame: Up to Day 29 (28 Days after double-blind vaccination on Day 1)]

Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study) [Time Frame: 28 Days after double-blind vaccination (Day 29)]

Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study) [Time Frame: 14 Days after double-blind vaccination (Day 15)]

Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study) [Time Frame: 1 Day after double-blind vaccination (Day 2)]

Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study) [Time Frame: 14 Days after double-blind vaccination (Day 15)]

Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) (Main Study) [Time Frame: 28 Days after double-blind vaccination (Day 29)]

Number of Participants With Asymptomatic Infection Detected by RT-PCR at the Time of the Month 6/Unblinding Visit (Main Study) [Time Frame: Month 6]

Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study) [Time Frame: 14 days after double-blind vaccination (Day 15)]

Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study) [Time Frame: 28 days after double-blind vaccination (Day 29)]

Number of Participants With Medically-Attended Adverse Events (MAAEs) (Main Study) [Time Frame: Up to 6 months after double-blind vaccination on Day 1]

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 (Main Study) [Time Frame: 14 Days after double-blind vaccination (Day 15)]

Number of Participant With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study) [Time Frame: 28 Days after double-blind vaccination (Day 29)]

Number of Participants With Adverse Events of Special Interest (AESI) (Main Study) [Time Frame: Up to 35 weeks]

Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study) [Time Frame: 14 Days after double-blind vaccination (Day 15)]

Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study) [Time Frame: 14 Days after double-blind vaccination (Day 15)]

Number of Participants With SARS-CoV-2 Seroconversion Based on Antibodies to N Protein Using ELISA and/or SARS-CoV-2 Immunoglobulin Assay (Main Study) [Time Frame: From Day 29 until end of double-blind phase (up to 284 days after first vaccination)]

Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study) [Time Frame: 28 Days after double-blind vaccination (Day 29)]

Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study) [Time Frame: 28 Days after double-blind vaccination (Day 29)]

Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination (Main Study) [Time Frame: Up to Day 8 (7 Days after double-blind vaccination on Day 1)]

Secondary ID(s)

CR108876

VAC31518COV3001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/04/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT04505722