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Virus Therapy

Ad26.COV2.S for Participants with or without co-morbidities associated with COVID-19. (ENSEMBLE 2 Trial)

Phase 3
Waitlist Available
Research Sponsored by Janssen Vaccines & Prevention B.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after the last vaccination (up to 34 weeks)
Awards & highlights

ENSEMBLE 2 Trial Summary

This trial will test if a new vaccine can prevent people from getting moderate to severe COVID-19. The study will also look at the safety of the vaccine and how well it works.

Eligible Conditions
  • Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19

ENSEMBLE 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after the last vaccination (up to 34 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after the last vaccination (up to 34 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Double Blind Phase and Open-label Phase: Number of Participants with Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19
Secondary outcome measures
Double Blind Phase and Open-label Phase: Number of Participants with Adverse Events of Special Interest (AESIs)
Double Blind Phase and Open-label Phase: Number of Participants with Medically-attended Adverse Events (MAAEs)
Double Blind Phase and Open-label Phase: Number of Participants with Medically-attended Adverse Events (MAAEs) Leading to Study Discontinuation
+15 more

Side effects data

From 2023 Phase 3 trial • 44325 Patients • NCT04505722
2%
Headache
2%
Chills
1%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ad26.COV2.S
Placebo

ENSEMBLE 2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ad26.COV2.SExperimental Treatment1 Intervention
Participants will receive intramuscular (IM) injection of Ad26.COV2.S vaccine on Day 1 and Day 57 in the double-blind phase. At unblinding visit (open-label phase), participants who have not yet received second vaccination will receive second dose of Ad26.COV2.S vaccine on Day 57, if applicable and newly enrolled participants will either receive IM injection of one dose of Ad26.COV2.S vaccine on Day 1 or two doses of Ad26.COV2.S vaccine on Day 1 and Day 57. All ongoing participants who only received a single vaccination with Ad26.COV2.S in the study will be offered to receive single booster dose of Ad26.COV2.S in the open label phase preferably within 6 to 12 months after the participant's first Ad26.COV2.S vaccination.
Group II: PlaceboPlacebo Group2 Interventions
Participants will receive IM injection of placebo on Day 1 and Day 57 in the double-blind phase. At unblinding visit (open-label phase), participants initially receiving placebo will be offered to receive IM injection of a single dose of Ad26.COV2.S vaccine. All ongoing participants who only received a single vaccination with Ad26.COV2.S in the study will be offered to receive single booster dose of Ad26.COV2.S in the open label phase preferably within 6 to 12 months after the participant's first Ad26.COV2.S vaccination.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ad26.COV2.S
2021
Completed Phase 3
~84050

Find a Location

Who is running the clinical trial?

Janssen Vaccines & Prevention B.V.Lead Sponsor
55 Previous Clinical Trials
1,102,517 Total Patients Enrolled
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
47 Previous Clinical Trials
103,725 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being observed in this experiment?

"This particular study is not looking for any more participants at this time. The trial was originally posted on 11/12/2020, with the latest update being on 10/25/2022. However, if you are interested in other studies, there are 1204 trials actively seeking patients with disease progression and 9 studies for Ad26.COV2.S that are still enrolling participants."

Answered by AI

Is Ad26.COV2.S a safe vaccine candidate for human use?

"Ad26.COV2.S has received a score of 3 for safety by our team at Power. This is because it is a Phase 3 trial, meaning that, in addition to some data supporting efficacy, there are multiple rounds of data supporting safety."

Answered by AI

Are there any other investigations using Ad26.COV2.S?

"Ad26.COV2.S was first introduced in 2020 by SGS Life Science Services. Out of the 18,243 clinical trials completed, 9 are still ongoing. The majority of these live studies are based out of Staten Island, New york."

Answered by AI

From how many different places is this clinical trial being monitored?

"There are 62 clinical trial sites running this study, located in various cities across the United States. Some of these locations include Richmond Behavioral Associates in Staten Island, American Health Network, LLC in Charlotte, and Lynn Health Science Institute in Oklahoma City."

Answered by AI

Are we still able to enroll people in this experiment?

"The latest information from clinicaltrials.gov indicates that this trial is not recruiting at this time. The study was initially posted on November 12th, 2020. There are 1213 other trials that are still currently looking for patients."

Answered by AI

Does this research project break new ground?

"Research into Ad26.COV2.S began in 2020 with the earliest trial sponsored by Janssen Vaccines & Prevention B.V.. After the first Phase 1 & 2 trial in 2020, which involved 1085 participants, Ad26.COV2.S received drug approval. Currently, 9 live studies are being conducted for Ad26.COV2.S in 131 cities across 19 countries."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Maryland
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Achieve Clinical Research, LLC
Clinical NeuroScience Solutions, Inc
Optimal Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

What questions have other patients asked about this trial?

Why did patients apply to this trial?

To help with research to find a cure. To further research and get more vaccines available.
PatientReceived 1 prior treatment
Recent research and studies
The Lancet Infectious DiseasesJournal
Efficacy, Safety, and Immunogenicity of a Booster Regimen of Ad26.cov2.s Vaccine Against COVID-19 (ENSEMBLE2): Results of a Randomised, Double-blind, Placebo-controlled, Phase 3 Trial
Hardt, Karin, An Vandebosch, Jerald Sadoff, Mathieu Le Gars, Carla Truyers, David Lowson, Ilse Van Dromme, et al.. 2022. “Efficacy, Safety, and Immunogenicity of a Booster Regimen of Ad26.cov2.s Vaccine Against COVID-19 (ENSEMBLE2): Results of a Randomised, Double-blind, Placebo-controlled, Phase 3 Trial”. The Lancet Infectious Diseases. Elsevier BV. doi:10.1016/s1473-3099(22)00506-0.
clinicaltrials.govStudy
A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults
2020. "A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04614948.
~7207 spots leftby Apr 2025
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