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Virus Therapy

Ad26.COV2.S for Coronavirus Prevention

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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after first vaccination on day 1 (up to day 8); 7 days after second vaccination on day 57 (up to day 64)
Awards & highlights

Study Summary

This trial is testing if a new vaccine is non-inferior to another vaccine in terms of immunity responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after first vaccination on day 1 (up to day 8); 7 days after second vaccination on day 57 (up to day 64)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after first vaccination on day 1 (up to day 8); 7 days after second vaccination on day 57 (up to day 64) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vaccination
Main Study: ELISA Geometric Mean Concentrations (GMCs) 28 Days After First Vaccination
Main Study: SARS-CoV-2 S Protein Binding Antibodies Concentration Measured by ELISA 14 Days After Second Vaccination
+1 more
Secondary outcome measures
Main Study: Number of Participants with AEs Leading to Study Discontinuation
Main and Sub Study: Number of Participants with Adverse Events of Special Interest (AESIs)
Main and Sub Study: Number of Participants with Medically-Attended Adverse Events (MAAEs)
+6 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

Trial Design

6Treatment groups
Experimental Treatment
Group I: Group 6: Ad26.COV2.S Dose Level 6Experimental Treatment1 Intervention
Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 6 on Days 1 and 57.
Group II: Group 5: Ad26.COV2.S Dose Level 5Experimental Treatment1 Intervention
Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 5 on Days 1 and 57.
Group III: Group 4: Ad26.COV2.S Dose Level 4Experimental Treatment1 Intervention
Participants will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 4 on Days 1 and 57 in the main study.
Group IV: Group 3: Ad26.COV2.S Dose Level 3Experimental Treatment1 Intervention
Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 3 on Days 1 and 57.
Group V: Group 2: Ad26.COV2.S Dose Level 2Experimental Treatment1 Intervention
Participants will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 2 on Days 1 and 57 in the main study.
Group VI: Group 1: Ad26.COV2.S Dose Level 1Experimental Treatment1 Intervention
Participants in the main study and sub study will receive intramuscular (IM) injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 1 on Days 1 and 57.
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
1,132,739 Total Patients Enrolled
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
47 Previous Clinical Trials
133,947 Total Patients Enrolled

Frequently Asked Questions

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

Does this trial have an age restriction?

"According to the age requirements set out in the inclusion criteria, the minimum age of patients that can enroll in this trial is 18 while the maximum age is 55."

Answered by AI

Where are the patients being recruited for this trial?

"Enrollment for this trial is currently underway at 6 clinical sites. These sites are located in Hallandale Beach, Miami, Maitland, and 6 other locations. If you enroll in this trial, it is advised that you choose the site closest to your residence to minimize travel."

Answered by AI

Are there other ongoing research projects using the Ad26.COV2.S virus?

"SGS Life Science Services first studied Ad26.COV2.S in 2020. This was followed by 5 completed trials. As of now, 9 studies are still ongoing with several of them based in Hallandale Beach, Florida."

Answered by AI

Is this a trial for a brand-new treatment?

"Janssen Vaccines & Prevention B.V. first sponsored a clinical trial for Ad26.COV2.S in 2020. The study completed its Phase 1 & 2 drug approval stage that year and involved 1085 participants. As of now, 9 active trials are taking place across 131 cities and 19 countries. Of these 9 trials, 5 have been completed."

Answered by AI

Who would be able to take part in this research project?

"This trial is admitting 1608 people for covid19 prevention. The patients must meet the following criteria: be between the ages of 18 and 55, be in good health as confirmed by medical history, physical examination, and vital signs, not have any comorbidities related to an increased risk of severe Coronavirus disease 2019 (COVID-19), agree to not donate bone marrow, blood, or blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine, be willing to provide verifiable identification, and have means to be contacted and to contact the investigator during the study."

Answered by AI

Are the risks Ad26.COV2.S low enough that it is worth trying?

"There is evidence from past trials to support Ad26.COV2.S's efficacy, and thus it receives a safety score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
California
Florida
How old are they?
18 - 65
What site did they apply to?
Ark Clinical Research
Tekton Research Inc.
Floridian Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

my mom almost ded because the virus and im wnt to help another people to prebent that.
PatientReceived no prior treatments
I'm a healthy person who needs money and if that helps to develop human health then both sides win.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy Adults
2021. "A Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04908722.
~420 spots leftby Apr 2025
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