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New COVID-19 RNA Vaccines for COVID-19
Phase 2 & 3
Waitlist Available
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capable of giving signed informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for 7 days following the study vaccination
Awards & highlights
Study Summary
This trial is seeking to learn about the safety, tolerability and immunogenicity of two different RNA-based SARS-CoV-2 vaccine candidates given as a booster dose in adults, with or without a history of receiving prior doses of a COVID-19 vaccine.
Who is the study for?
Healthy individuals aged 12-55 with prior COVID-19 vaccinations, including a booster shot received at least 90 days before the study. Participants must be able to consent and follow the study schedule. Excluded are those on immunosuppressants, with severe vaccine reactions or bleeding disorders, pregnant/breastfeeding women, and anyone with conditions that may risk participation.Check my eligibility
What is being tested?
The trial is testing new RNA COVID-19 vaccines in people who've had previous vaccinations. It involves single doses of various bivalent (targeting two strains) or monovalent (single strain) vaccines to assess safety and immune response over approximately six months with multiple clinic visits for blood sampling.See study design
What are the potential side effects?
Potential side effects include typical vaccine reactions like soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea; rare risks may involve allergic reactions or heart inflammation as seen in very few cases with similar vaccines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to understand and sign the consent form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for 7 days following the study vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for 7 days following the study vaccination
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All Cohorts: Percentage of participants reporting adverse events
All Cohorts: Percentage of participants reporting local reactions
All Cohorts: Percentage of participants reporting serious adverse events
+14 moreSecondary outcome measures
Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): % of participants with seroresponse to BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 SSE) for GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels.
Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 Substudy E).
Cohorts 2+3 (18-55 yrs), Cohorts 2+3 (>55 yrs): GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 Substudy E).
+1 moreTrial Design
14Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 4: BNT162b7 Monovalent (OMI BA.4/BA.5)Experimental Treatment1 Intervention
Participants will receive 30 µg of BNT162b7 Monovalent (OMI BA.4/BA.5) at Visit 1
Group II: Cohort 4: BNT162b7 Bivalent (Original/OMI BA.4/BA.5)Experimental Treatment1 Intervention
Participants will receive 30 µg of BNT162b7 Bivalent (Original/OMI BA.4/BA.5) at Visit 1
Group III: Cohort 4: BNT162b6 Bivalent (Original/OMI BA.4/BA.5)Experimental Treatment1 Intervention
Participants will receive 30 µg of BNT162b6 Bivalent (Original/OMI BA.4/BA.5) at Visit 1
Group IV: Cohort 4: BNT162b5 Bivalent (Original/OMI BA.4/BA.5)Experimental Treatment1 Intervention
Participants will receive 30 µg of BNT162b5 Bivalent (Original/OMI BA.4/BA.5) at Visit 1
Group V: Cohort 3 - Group 2: >55 years; 30 µgExperimental Treatment1 Intervention
Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg at Visit 1.
Group VI: Cohort 3 - Group 1: 18-55 years; 30 µgExperimental Treatment1 Intervention
Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg at Visit 1.
Group VII: Cohort 2 -Group 1: 12-17 years; 30 µgExperimental Treatment1 Intervention
Participants 12-17 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
Group VIII: Cohort 2 - Group 5: >55 years; 60 µgExperimental Treatment1 Intervention
Participants over 55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
Group IX: Cohort 2 - Group 4: >55 years; 30 µgExperimental Treatment1 Intervention
Participants over 55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
Group X: Cohort 2 - Group 3: 18-55 years; 60 µgExperimental Treatment1 Intervention
Participants 18-55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
Group XI: Cohort 2 - Group 2: 18-55 years; 30 µgExperimental Treatment1 Intervention
Participants 18-55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
Group XII: Cohort 1: BNT162b5 Bivalent (WT/OMI BA.2)Experimental Treatment1 Intervention
Participants will receive 30 µg of BNT162b5 Bivalent (WT/OMI BA.2) at Visit 1.
Group XIII: Cohort 1: BNT162b2 Bivalent (WT/OMI BA.1)Experimental Treatment1 Intervention
Participants will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.1) at Visit 1.
Group XIV: Cohort 4: BNT162b2 Bivalent (Original/OMI BA.4/BA.5)Active Control1 Intervention
Participants will receive 30 µg of BNT162b2 Bivalent (Original/OMI BA.4/BA.5) at Visit 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BNT162b2 Bivalent (WT/OMI BA.1)
2022
Completed Phase 3
~1460
BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
2022
Completed Phase 3
~1460
BNT162b7 Monovalent (OMI BA.4/BA.5)
2022
Completed Phase 3
~1460
BNT162b6 Bivalent (Original/OMI BA.4/BA.5)
2022
Completed Phase 3
~1460
BNT162b7 Bivalent (Original/OMI BA.4/BA.5)
2022
Completed Phase 3
~1460
BNT162b5 Bivalent (Original/OMI BA.4/BA.5)
2022
Completed Phase 3
~1460
BNT162b5 Bivalent (WT/OMI BA.2)
2022
Completed Phase 3
~1460
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,568 Previous Clinical Trials
10,910,432 Total Patients Enrolled
67 Trials studying COVID-19
1,437,229 Patients Enrolled for COVID-19
BioNTech SELead Sponsor
64 Previous Clinical Trials
107,727 Total Patients Enrolled
20 Trials studying COVID-19
97,115 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,091,600 Total Patients Enrolled
49 Trials studying COVID-19
1,426,006 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received a COVID-19 booster shot at least 90 days before the first study visit and have documentation for all my COVID-19 vaccinations.I am within the age range specified for one of the study cohorts.I am between 18 and 55 years old and generally healthy.I have not received blood products or antibodies within 60 days before the study vaccine.I haven't taken immunosuppressants or had radiotherapy in the last 60 days.I am not pregnant or breastfeeding.I am able to understand and sign the consent form.You are willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.I am generally healthy, even if I have a stable chronic condition.You had a serious allergic reaction to a vaccine or any of its ingredients in the past.You have a known or suspected weak immune system.I do not have a bleeding condition that makes injections unsafe for me.I have had myocarditis or pericarditis in the past.I am able to understand and sign the consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2 - Group 3: 18-55 years; 60 µg
- Group 2: Cohort 2 -Group 1: 12-17 years; 30 µg
- Group 3: Cohort 2 - Group 4: >55 years; 30 µg
- Group 4: Cohort 4: BNT162b7 Monovalent (OMI BA.4/BA.5)
- Group 5: Cohort 3 - Group 2: >55 years; 30 µg
- Group 6: Cohort 4: BNT162b2 Bivalent (Original/OMI BA.4/BA.5)
- Group 7: Cohort 4: BNT162b7 Bivalent (Original/OMI BA.4/BA.5)
- Group 8: Cohort 1: BNT162b2 Bivalent (WT/OMI BA.1)
- Group 9: Cohort 2 - Group 2: 18-55 years; 30 µg
- Group 10: Cohort 1: BNT162b5 Bivalent (WT/OMI BA.2)
- Group 11: Cohort 3 - Group 1: 18-55 years; 30 µg
- Group 12: Cohort 4: BNT162b6 Bivalent (Original/OMI BA.4/BA.5)
- Group 13: Cohort 2 - Group 5: >55 years; 60 µg
- Group 14: Cohort 4: BNT162b5 Bivalent (Original/OMI BA.4/BA.5)
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.
COVID-19 Patient Testimony for trial: Trial Name: NCT05472038 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there a lot of sites conducting this research in the US?
"This study is currently underway at 33 different research facilities, such as Cellular Technology Limited in Shaker Heights, Texas Center for Drug Development, Inc. in Houston, and DM Clinical Research in Tomball."
Answered by AI
Does this trial target a older patient demographic?
"Per the inclusion criteria, only patients aged 12 to 55 are eligible for this clinical trial. However, there are 145 other studies available for minors and 988 trials geared towards seniors."
Answered by AI
What are the prerequisites to enrolling in this experiment?
"To qualify for this research, volunteers must have contracted covid19 and be between the ages of 12-55. Currently, the study is looking to enroll approximately 1143 individuals."
Answered by AI
Are there any available openings for individuals who would like to participate in this research?
"As can be seen on clinicaltrials.gov, this study is no longer actively recruiting patients. Although the last update was on October 13th 2022, this study originally posted on July 26th of the same year. There are many other studies (1142 to be exact) that are still looking for patients."
Answered by AI
What are the research goals of this experiment?
"The primary objective of this clinical trial, which will end after 6 months, is to compare the percentage of patients that respond to BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg in terms of GMTs of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels.. Additionally, the study hopes to observe Cohorts 2+3 (18-55 yrs), Cohorts 2+3 (>55 y"
Answered by AI
Who else is applying?
What state do they live in?
Texas
Georgia
California
Other
How old are they?
18 - 65
What site did they apply to?
Anaheim Clinical Trials, LLC
Accellacare - Wilmington
Clinical Research Atlanta
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
What questions have other patients asked about this trial?
How much is the payment for this trial?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
To help find a treatment that works. Healthy volunteer and received email.
PatientReceived no prior treatments
I am interested in helping with vaccine research to improve outcomes for people infected with COVID-19.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Anaheim Clinical Trials, LLC: < 24 hours
Average response time
- < 1 Day
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