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Virus Vaccine
Ad26.COV2.S for Coronavirus
Phase 1 & 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
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 day 1 through study completion (approximately 12 months for cohort 1 and for those cohort 2 individuals not receiving a second boost and approximately 6 months after second boost for individuals in cohort 2).
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of different booster shots for people who have already received a Covid-19 vaccine under emergency use authorization.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through study completion (approximately 12 months for cohort 1 and for those cohort 2 individuals not receiving a second boost and approximately 6 months after second boost for individuals in cohort 2).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through study completion (approximately 12 months for cohort 1 and for those cohort 2 individuals not receiving a second boost and approximately 6 months after second boost for individuals in cohort 2).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Magnitude of SARS-CoV-2 specific antibody binding and neutralization titers
Occurrence of Adverse Events of Special Interest (AESIs).
Occurrence of New-Onset Chronic Medical Condition (NOCMCs).
+5 moreTrial Design
18Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment4 Interventions
A prospective design cohort with naïve to COVID-19 vaccine and infection participants of > / = 18 years of age to receive COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at the 100mcg dose at a 28 days of interval) followed by a delayed booster vaccination (50 mcg mRNA-1273) after a minimum of 12 weeks. Additional pools of subjects can be included as additional COVID-19 vaccines are awarded EUA (e.g., Janssen - Ad26.COV2.S or Novavax- NVX-CoV2373). A second booster (fourth dose) will be administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at a 4-12 month interval N=250
Group II: Cohort 1 Group 9EExperimental Treatment1 Intervention
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
Group III: Cohort 1 Group 8EExperimental Treatment1 Intervention
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
Group IV: Cohort 1 Group 7EExperimental Treatment1 Intervention
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10^10 vp stratified with two age ranges of 18-55 years (n=˜ 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
Group V: Cohort 1 Group 6EExperimental Treatment1 Intervention
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (delayed boost dose). N = 50
Group VI: Cohort 1 Group 5EExperimental Treatment1 Intervention
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (delayed boost dose). N = 50
Group VII: Cohort 1 Group 4EExperimental Treatment1 Intervention
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S at 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (delayed boost dose). N = 50
Group VIII: Cohort 1 Group 3EExperimental Treatment1 Intervention
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n ˜ 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (delayed boost dose). N = 50
Group IX: Cohort 1 Group 2EExperimental Treatment1 Intervention
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (delayed boost dose). N = 50
Group X: Cohort 1 Group 1EExperimental Treatment1 Intervention
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (delayed boost dose). N = 50
Group XI: Cohort 1 Group 17EExperimental Treatment1 Intervention
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
Group XII: Cohort 1 Group 16EExperimental Treatment1 Intervention
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
Group XIII: Cohort 1 Group 15EExperimental Treatment1 Intervention
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10^10 vp for one or two doses stratified with two age ranges of 18-55 years (n= 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
Group XIV: Cohort 1 Group 14EExperimental Treatment2 Interventions
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
Group XV: Cohort 1 Group 13EExperimental Treatment1 Intervention
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
Group XVI: Cohort 1 Group 12EExperimental Treatment2 Interventions
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA- 1273 N = 50
Group XVII: Cohort 1 Group 11EExperimental Treatment1 Intervention
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (delayed boost dose). N = 50
Group XVIII: Cohort 1 Group 10EExperimental Treatment1 Intervention
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (delayed boost dose). N = 50
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1273.211
2021
Completed Phase 3
~6280
mRNA-1273.222
2021
Completed Phase 3
~6280
SARS-CoV-2 rS/M1
2021
Completed Phase 2
~870
Ad26.COV2.S
2021
Completed Phase 3
~84050
BNT162b2
2021
Completed Phase 4
~91740
mRNA-1273
2021
Completed Phase 4
~58700
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,265 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition that weakens your immune system or a disease that affects your immune system.You have experienced severe allergic reactions or serious side effects after receiving a vaccine or nanolipid particles.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 Group 5E
- Group 2: Cohort 1 Group 1E
- Group 3: Cohort 1 Group 11E
- Group 4: Cohort 1 Group 15E
- Group 5: Cohort 1 Group 16E
- Group 6: Cohort 1 Group 4E
- Group 7: Cohort 1 Group 6E
- Group 8: Cohort 1 Group 12E
- Group 9: Cohort 1 Group 13E
- Group 10: Cohort 1 Group 14E
- Group 11: Cohort 1 Group 2E
- Group 12: Cohort 1 Group 17E
- Group 13: Cohort 1 Group 3E
- Group 14: Cohort 1 Group 10E
- Group 15: Cohort 1 Group 7E
- Group 16: Cohort 1 Group 8E
- Group 17: Cohort 1 Group 9E
- Group 18: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Coronavirus Patient Testimony for trial: Trial Name: NCT04889209 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals over 40 eligible to participate in this clinical experiment?
"In order to meet the eligibility criteria for this study, potential participants should be aged 18 or above and no older than 99."
Answered by AI
Is this trial the premier of its variety?
"At present, 51 experiments using the Ad26.COV2.S vaccine are underway in 354 cities and 43 different countries since its first trial by BioNTech SE in 2020. This study included 512 patients throughout Phase 1 & 2 of drug approval, with an additional 29 studies occurring afterwards."
Answered by AI
Are there any availabilities for participants in this trial?
"Affirmative. The clinicaltrial.gov registry lists this medical trial as actively recruiting participants, having been posted on May 28th 2021 and updated most recently on December 8th 2022. Across 16 different sites, 1130 patients need to be enrolled in the study."
Answered by AI
What are the requirements for a patient to participate in this experiment?
"In order to be accepted, applicants for this medical trial must have been exposed to Covid-19 and fall between 18 and 99 years of age. Currently, 1130 volunteers are required."
Answered by AI
What is the upper limit of individuals recruited for this clinical trial?
"This research project necessitates the involvement of 1130 suitable individuals. The Administrative Documents Site in Rockville, Maryland and New york University School of Medicine - Langone Medical Center - Microbiology - Parasitology in NYC are two locales where participants can enroll."
Answered by AI
What other research projects have been conducted on Ad26.COV2.S?
"Currently, 51 experiments are being conducted for Ad26.COV2.S; 18 of these trials have progressed to the Phase 3 level. While Liverpool and New york City host most studies related to this drug, there is a total of 1873 locations running clinical research on it."
Answered by AI
In which medical institutions is this experiment being conducted?
"Currently, 16 trial sites are recruiting patients for this medical experiment. The major cities of Rockville, New york and Houston as well as 13 other locations offer the same study. To ensure a convenient experience it is important to select the closest site when enrolling in order to limit travel requirements."
Answered by AI
Who else is applying?
What state do they live in?
District of Columbia
Texas
Virginia
How old are they?
18 - 65
What site did they apply to?
Baylor College of Medicine - Molecular Virology and Microbiology
Administrative Documents Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
It seems the right thing to do.
PatientReceived 2+ prior treatments
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