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Virus Therapy

Investigational COVID-19 Booster Vaccine for Healthy People

Phase 1
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
Men who are willing to refrain from sperm donation, starting at Visit 0 and continuously until 28 days after receiving the last IMP dose
Are aged 18 years and older at randomization, have a body mass index over 18.5 kg/m^2 and under 35 kg/m^2, and weigh at least 50 kg at Visit 0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 until day 180
Awards & highlights

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.

Who is the study for?
Healthy adults over 18 who've had at least three RNA-based COVID-19 vaccines can join this trial. They must not plan to use non-trial vaccines or participate in other drug trials from a month before until six months after the last dose, and agree to contraception measures. Excluded are those with recent substance abuse, severe allergies to vaccines, certain chronic diseases, recent SARS-CoV-2 infection, or treatments that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing different doses of BNT162b4 as a booster shot combined with either BNT162b2 Monovalent (OMI XBB.1.5) or Bivalent (original/Omicron BA.4/BA.5). It's observer-blind for the first dose and open-label for the second, using staggered dosing based on safety data from previous levels.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions like soreness at injection site, fatigue, headache, muscle pain, chills, fever and nausea. Serious side effects are rare but might involve allergic reactions or heart inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree not to donate sperm from the start of the trial until 28 days after the last dose.
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I am over 18, my BMI is between 18.5 and 35, and I weigh at least 50 kg.
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I have received the first dose of BNT162b4 + BNT162b2 vaccine in this trial.
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I am a man who will use effective birth control methods during and after the trial.
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I agree not to get non-trial vaccines from 28 days before to 28 days after the last trial dose.
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I have received at least three doses of an RNA COVID-19 vaccine approved in the US.
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I agree not to get non-trial COVID-19 vaccines 90 days before and until my last trial visit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 until day 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 until day 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of participants with at least one adverse event (AE) occurring up to 28 days after every IMP dose for each DL cohort
Frequency of participants with at least one serious adverse event (SAE) occurring up to 6 months after every IMP dose for each DL cohort
Frequency of participants with solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after every investigational medicinal product (IMP) dose for each DL cohort
+4 more
Secondary outcome measures
Geometric mean fold rises (GMFRs) from baseline (pre-Dose 1) to every subsequent timepoint for each DL cohort
Geometric mean titers (GMT) at each time point for each DL cohort
Percentages of participants with seroresponse at each timepoint after every IMP dose for each DL cohort

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 30 µg - participants aged >55 yearsExperimental Treatment3 Interventions
Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg. Cohort 4b. Two doses (At Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 30 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg
Group II: BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 30 µg - participants aged 18-55 yearsExperimental Treatment3 Interventions
Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg. Cohort 4a. Two doses (At Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 30 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg
Group III: BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 15 µg - participants aged >55 yearsExperimental Treatment3 Interventions
Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg. Cohort 3b. Two doses (At Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 15 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg
Group IV: BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 15 µg - participants aged 18-55 yearsExperimental Treatment3 Interventions
Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg. Cohort 3a. Two doses (At Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 15 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg
Group V: BNT162b2 Bivalent 30 µg + BNT162b4 5 µg - participants aged 18-55 yearsExperimental Treatment2 Interventions
Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 5 µg. Cohort 1. Two doses (At Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1).
Group VI: BNT162b2 Bivalent 30 µg + BNT162b4 10 µg - participants aged 18-55 yearsExperimental Treatment2 Interventions
Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 10 µg. Cohort 2. Two doses (At Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1)
Group VII: BNT612b2 Bivalent 30 µg - participants aged >55 yearsActive Control1 Intervention
Intramuscular injection at Day 1. Cohort 3b. BNT612b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg.
Group VIII: BNT612b2 Bivalent 30 µg - participants aged 18-55 yearsActive Control1 Intervention
Intramuscular injection at Day 1. Cohorts 1, 2 and 3a. BNT612b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BioNTech SELead Sponsor
63 Previous Clinical Trials
107,813 Total Patients Enrolled
20 Trials studying COVID-19
98,299 Patients Enrolled for COVID-19
PfizerIndustry Sponsor
4,556 Previous Clinical Trials
10,907,323 Total Patients Enrolled
67 Trials studying COVID-19
1,438,608 Patients Enrolled for COVID-19
BioNTech Responsible PersonStudy DirectorBioNTech SE
32 Previous Clinical Trials
8,298 Total Patients Enrolled
5 Trials studying COVID-19
2,710 Patients Enrolled for COVID-19

Media Library

BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05541861 — Phase 1
COVID-19 Research Study Groups: BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 30 µg - participants aged 18-55 years, BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 15 µg - participants aged 18-55 years, BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 15 µg - participants aged >55 years, BNT612b2 Bivalent 30 µg - participants aged >55 years, BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 30 µg - participants aged >55 years, BNT612b2 Bivalent 30 µg - participants aged 18-55 years, BNT162b2 Bivalent 30 µg + BNT162b4 5 µg - participants aged 18-55 years, BNT162b2 Bivalent 30 µg + BNT162b4 10 µg - participants aged 18-55 years
COVID-19 Clinical Trial 2023: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg Highlights & Side Effects. Trial Name: NCT05541861 — Phase 1
BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05541861 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What site did they apply to?
Alliance for Multispecialty Research, LLC (Kansas)
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I think that it's important to have vaccines available. I know that the only way to find new vaccines and medicines is through clinical trials.
PatientReceived no prior treatments
~98 spots leftby Oct 2024