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Investigational COVID-19 Booster Vaccine for Healthy People
Study Summary
This trial will test 3 doses of a combined vaccine to find a safe and tolerable dose for use. It will use a staggered dosing process with sentinel participants in all cohorts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- Your blood tests show abnormal levels that are considered Grade 1 or higher, or you have abnormal levels of C-reactive protein or troponin I.I agree not to donate sperm from the start of the trial until 28 days after the last dose.I do not have severe health issues or recent treatments that could interfere with the trial.I am over 18, my BMI is between 18.5 and 35, and I weigh at least 50 kg.I have received the first dose of BNT162b4 + BNT162b2 vaccine in this trial.I am a man who will use effective birth control methods during and after the trial.I agree not to get non-trial vaccines from 28 days before to 28 days after the last trial dose.Your test for Hepatitis B surface antigen came back negative at the beginning of the study.I have received at least three doses of an RNA COVID-19 vaccine approved in the US.You need to have a negative HIV test before starting the study.I agree not to get non-trial COVID-19 vaccines 90 days before and until my last trial visit.If you can have babies, you need to have a negative pregnancy test before starting the study.You have had a serious reaction to vaccines or their ingredients in the past, including symptoms like hives, trouble breathing, swelling, or severe stomach pain.You do not have Hepatitis C virus, or if you have it, the virus is not detected in your blood.
- Group 1: BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 30 µg - participants aged 18-55 years
- Group 2: BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 15 µg - participants aged 18-55 years
- Group 3: BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 15 µg - participants aged >55 years
- Group 4: BNT612b2 Bivalent 30 µg - participants aged >55 years
- Group 5: BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 30 µg - participants aged >55 years
- Group 6: BNT612b2 Bivalent 30 µg - participants aged 18-55 years
- Group 7: BNT162b2 Bivalent 30 µg + BNT162b4 5 µg - participants aged 18-55 years
- Group 8: BNT162b2 Bivalent 30 µg + BNT162b4 10 µg - participants aged 18-55 years
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is this experiment open to elderly participants?
"The demographic of those eligible to partake in this trial is limited to individuals between the ages of 18 and 55. For minors and senior citizens, there are 142 trials suitable for them and 921 respectively."
What is the total number of individuals who have currently enrolled in this experiment?
"This medical research necessitates the enrolment of 180 appropriate candidates across two distinct sites: Endeavor Clinical Trials, LLC in San Antonio and Hoag Hospital in Newport Beach."
Has the FDA approved BNT162b5 as a bivalent combination of 30 µg BNT162b2 and 15 µg BNT162b4?
"The safety of the BNT162b5 and BNT162b2-B4 combinations has been assessed to be at a level 1, as this is an early phase trial with limited data on efficacy and safety."
Is there an ongoing invitation for participants in this trial?
"Research posted on clinicaltrials.gov reveals that this investigation is actively recruiting patients, with its inception being recorded as November 8th 2022 and the most recent data update occurring December 6th 2022."
What criteria must individuals meet to participate in this research endeavor?
"To be eligible for this covid19 clinical trial, individuals must have contracted the illness and aged between 18-55 years. The total number of participants is expected to reach 180 people."
What is the geographical extent of this trial's reach?
"Endeavor Clinical Trials, LLC in San Antonio, Hoag Hospital in Newport Beach and University of Kentucky Center for Clinical and Translational Science (outpatient clinic) in Lexington are 3 amongst 12 different sites that are currently participating."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
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