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Virus Therapy

Ad26.COV2.S for COVID-19 (Amplify Trial)

Phase 2
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 up to 7 days after booster vaccination (up to day 8)
Awards & highlights

Amplify Trial Summary

This trial will test the effectiveness of a booster shot of the adenovirus type 26 COVID-19 vaccine (Ad26.COV2.S) in people who have already received a single dose of the vaccine, as well as in people who have received two doses of Pfizer’s BNT162b2 vaccine. The trial will compare the neutralizing antibody response to the original SARS-CoV-2 strain and to variants of concern 14 days after receiving the booster shot.

Eligible Conditions
  • COVID-19

Amplify Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 days after booster vaccination (up to day 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days after booster vaccination (up to day 8) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort 1: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 28 Days After Primary Vaccination With Ad26.COV2.S
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Delta Variant) 14 Days After Ad26.COV2.S Booster Vaccination (5*10^10 vp Dose Level) After Completing Primary Vaccination With Ad26.COV2.S
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Delta Variant) 28 Days After Primary Vaccination With Ad26.COV2.S (5*10^10 vp Dose Level)
+13 more
Secondary outcome measures
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination
Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 14 Days After Ad26.COV2.S Booster Vaccination
+23 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

Amplify Trial Design

6Treatment groups
Experimental Treatment
Group I: Cohort 2: Group 6: Ad26.COV2.S (Dose Level 3)Experimental Treatment1 Intervention
Participants who have previously received primary vaccination with BNT162b2 will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 3 on Day 1.
Group II: Cohort 2: Group 5: Ad26.COV2.S (Dose Level 2)Experimental Treatment1 Intervention
Participants who have previously received primary vaccination with BNT162b2 will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 2 on Day 1.
Group III: Cohort 2: Group 4: Ad26.COV2.S (Dose Level 1)Experimental Treatment1 Intervention
Participants who have previously received primary vaccination with BNT162b2 will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 1 on Day 1.
Group IV: Cohort 1: Group 3: Ad26.COV2.S (Dose Level 3)Experimental Treatment1 Intervention
Participants who have previously received primary vaccination with Ad26.COV2.S will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 3 on Day 1.
Group V: Cohort 1: Group 2: Ad26.COV2.S (Dose Level 2)Experimental Treatment1 Intervention
Participants who have previously received primary vaccination with Ad26.COV2.S will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 2 on Day 1.
Group VI: Cohort 1: Group 1: Ad26.COV2.S (Dose Level 1)Experimental Treatment1 Intervention
Participants who have previously received primary vaccination with Ad26.COV2.S will receive single intramuscular (IM) injection of Ad26.COV2.S booster vaccination at dose level 1 on Day 1.
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
1,132,807 Total Patients Enrolled
6 Trials studying COVID-19
577,643 Patients Enrolled for COVID-19
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
47 Previous Clinical Trials
134,015 Total Patients Enrolled
5 Trials studying COVID-19
77,643 Patients Enrolled for COVID-19

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
South Carolina
How old are they?
18 - 65
What site did they apply to?
Velocity Clinical Research, Anderson
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2
2021. "A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04999111.
~420 spots leftby Apr 2025
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