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Study Summary
This trial is evaluating the safety and immunogenicity of booster shots for the BNT162b2 vaccine. It will also evaluate the safety and immunogenicity of a three-dose regimen of BNT162b2 for people who have not received the vaccine before. Additionally, the trial will compare the natural immunity response to the Omicron variant of the SARS-CoV-2 virus with the immunity response from the BNT162b2 vaccine.
- Coronavirus
- COVID-19
- SARS
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 4 trial • 160 Patients • NCT04588480Trial Design
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- You have or had heart problems like heart inflammation, heart attack, heart failure, or serious heart rhythm problems.You have a medical or mental health condition, or recent thoughts or actions of wanting to harm yourself, that the doctor thinks would make it unsafe for you to participate in the trial.You have a weakened immune system or are prone to getting sick easily.You have a condition that causes prolonged bleeding, making it unsafe to receive an injection into the muscle.You have had a serious allergic reaction to a vaccine or any ingredient in the study medication.You have had Guillain-Barré syndrome in the past.
- Group 1: Part B - Cohort 1: 18 to 85 years of age
- Group 2: Part A - Cohort 3: 18 to 55 years of age
- Group 3: Part A - Cohort 4: 18 to 55 years of age
- Group 4: Part C - Cohort 9: 18 to 85 years of age
- Group 5: Part C - Cohort 8: 18 to 85 years of age
- Group 6: Part A - Cohort 1: 18 to 55 years of age
- Group 7: Part A - Cohort 5: 18 to 55 years of age
- Group 8: Part A - Cohort 6: 18 to 55 years of age
- Group 9: Part A - Cohort 2: 18 to 55 years of age
- Group 10: Part B - Cohort 4: 18 to 85 years of age
- Group 11: Part C - Cohort 7: 18 to 85 years of age
- Group 12: Part B - Cohort 6: 18 to 85 years of age
- 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
Does this research study accommodate participants aged eighty and older?
"According to the criteria for participation, individuals aged 18 and over but younger than 85 are allowed to enrol in this medical trial."
Is this endeavor unprecedented in its field?
"Currently, there are 27 ongoing studies of BNT162b2 taking place in 220 cities and across 27 countries. The initial trials were completed by BioNTech SE back in 2020, featuring 512 participants which successfully passed Phase 1 & 2 testing. Since then, 71 additional investigations have been concluded."
Are participants currently being enrolled for this clinical trial?
"Evidently, the clinical trial listed on clinicaltrials.gov is not actively seeking participants at this time; it was initially posted in August 2021 and last edited November 2022. However, there are an abundance of other trials currently recruiting patients from across 1147 different studies."
Does this trial have an open enrollment period where I can sign up?
"This clinical trial is recruiting 1383 participants, aged between 18 and 85, who have respiratory issues. Potential enrollees must satisfy the following criteria: sign an ICF prior to any study-related activities; be in age range of Part A (18 - 55 years old) or B & C (18 - 85 years old); for cohorts 1 to 5, have already been administered two doses of BNT162b2 at least 6 months earlier outside this trial; for cohort 6 be vaccine naïve and not infected with COVID-19 previously; willing to comply with all scheduled visits and tests; healthy according to investigator's assessment based on medical"
Has the FDA sanctioned BNT162b2 for public use?
"Due to the lack of clinical data on BNT162b2's efficacy, our team has assigned a rating of 2 for safety. The Phase 2 nature of this trial does however indicate that there is some prior evidence supporting its safety profile."
Have any other research efforts been conducted with BNT162b2?
"Presently, 27 clinical trials are being conducted for BNT162b2. Six of these active studies have reached Phase 3 stage and there are 762 sites in Roskilde, Aarhus N where research is being done."
What is the primary aim of this medical study?
"Per the clinical trial sponsor, BioNTech SE, the primary outcome which is assessed from Dose 1 up to one month after will be Participants' Reports of Serious Adverse Events (SAEs). Furthermore, this study also evaluates secondary outcomes including VOC NT in RNA-based COVID-19 vaccine-experienced participants with history of SARS-CoV-2 infection at baseline and 7 days, 1 month and 3 months post commencement for Cohorts 7, 8 & 9 as well as 6 or 12 months post initiation for cohorts 7 & 8; For BNT162b2-experience subjects previously receiving two injections of 30"
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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