CompletedPhase 1

Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People

United States383 participantsStarted 2022-11-08

Plain-language summary

This was an exploratory Phase I, randomized, observer-blind, active-controlled, dose-escalation trial to evaluate four dose levels (DLs) of BNT162b4 given in combination with BNT162b2 Bivalent (original/Omicron BA.4/BA.5) to select a safe and tolerable dose and to evaluate BNT162b4 + BNT162b2 Bivalent (original/Omicron BA.4/BA.5) when given as Dose 1 and Dose 2 (booster) in Cohorts 1 and 2 and BNT162b4 + BNT162b2 Monovalent (OMI XBB.1.5) when given as Dose 2 (booster) in Cohorts 3a, 3b, 4a, and 4b, and 30 microgram (mcg) BNT162b4 when given alone as Dose 1 and Dose 2 in Cohort 5. The trial used a staggered dosing process schema, i.e., enrollment into the next higher dose level was done sequentially and subject to safety data from the previous dose levels, with sentinel participants in Cohorts 1, 2, 3a, and 4a. Cohort 3b investigating the same dose level as cohort 3a but in participants aged \>55 years was opened after safety data for participants aged 18-55 years in Cohort 3a had been reviewed. Enrollment into Cohorts 4a and 4b was opened after safety data for Cohort 3a and 3b had been reviewed. Cohort 5 participants were not randomized and received two doses of BNT162b4 alone after which a safety review was performed after all participants received Dose 2 in this cohort. BNT162b4 plus BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) was co-administered (as a single injection). BNT162b4 alone was administered as a single injection.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Uncontrolled or moderate or severe respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease); symptoms of asthma severity as defined in the most recent US National Heart, Lung, and Blood Institute asthma management guidelines.
✕. Diabetes mellitus type 1 or type 2, or new onset of Diabetes mellitus type 1 or 2 from the administration of Dose 1, including cases controlled with diet alone (Not excluded: history of isolated gestational diabetes).
✕. Hypertension:
✕. Any current or history of cardiovascular diseases such as myocarditis, pericarditis, myocardial infarction, symptomatic congestive heart failure, cardiomyopathy or clinically significant arrhythmias. Exclusion pertaining to Dose 2 (all cohorts): Participants who had new onset of cardiovascular disease since enrollment, that, in the opinion of the investigator would constitute an increased risk to the individual's participation in Dose 2 would not receive Dose 2.
✕. A diagnosed bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions). Exclusion pertaining to Dose 2 (all cohorts): Participants who had new onset of a bleeding disorder since enrollment, that, in the opinion of the investigator, would constitute an increased risk to the individual's participation in Dose 2 would not receive Dose 2.
✕. Seizure disorders: History of seizure(s) within the past 3 years. Also excluded if participant had used medications in order to prevent or treat seizure(s) at any time within the past 3 years.

What they're measuring

Number of Participants With Solicited Local Reactions- Post Dose 1

Timeframe: Up to 7 days post-dose1

Number of Participants With Solicited Local Reactions- Post Dose 2

Timeframe: Up to 7 days post-dose 2

Number of Participants With Solicited Systemic Events- Post Dose 1

Timeframe: Up to 7 days post-dose 1

Number of Participants With Solicited Systemic Events- Post Dose 2

Timeframe: Up to 7 days post-dose 2

Number of Participants With Adverse Events (AEs)-Post Dose 1

Timeframe: Up to 28 days post-dose 1

Number of Participants With Adverse Events (AEs)-Post Dose 2

Timeframe: Up to 28 days post-dose 2

Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1

Timeframe: Up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and up to 2 months post-dose 1 for Cohort 5

Trial details

NCT IDNCT05541861

SponsorBioNTech SE

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-22

Results submitted2025-11-20

View on ClinicalTrials.gov More SARS-CoV-2 Infection trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Uncontrolled or moderate or severe respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease); symptoms of asthma severity as defined in the most recent US National Heart, Lung, and Blood Institute asthma management guidelines.
✕. Diabetes mellitus type 1 or type 2, or new onset of Diabetes mellitus type 1 or 2 from the administration of Dose 1, including cases controlled with diet alone (Not excluded: history of isolated gestational diabetes).
✕. Hypertension:
✕. Any current or history of cardiovascular diseases such as myocarditis, pericarditis, myocardial infarction, symptomatic congestive heart failure, cardiomyopathy or clinically significant arrhythmias. Exclusion pertaining to Dose 2 (all cohorts): Participants who had new onset of cardiovascular disease since enrollment, that, in the opinion of the investigator would constitute an increased risk to the individual's participation in Dose 2 would not receive Dose 2.
✕. A diagnosed bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions). Exclusion pertaining to Dose 2 (all cohorts): Participants who had new onset of a bleeding disorder since enrollment, that, in the opinion of the investigator, would constitute an increased risk to the individual's participation in Dose 2 would not receive Dose 2.
✕. Seizure disorders: History of seizure(s) within the past 3 years. Also excluded if participant had used medications in order to prevent or treat seizure(s) at any time within the past 3 years.

What they're measuring

Number of Participants With Solicited Local Reactions- Post Dose 1

Timeframe: Up to 7 days post-dose1

Number of Participants With Solicited Local Reactions- Post Dose 2

Timeframe: Up to 7 days post-dose 2

Number of Participants With Solicited Systemic Events- Post Dose 1

Timeframe: Up to 7 days post-dose 1

Number of Participants With Solicited Systemic Events- Post Dose 2

Timeframe: Up to 7 days post-dose 2

Number of Participants With Adverse Events (AEs)-Post Dose 1

Timeframe: Up to 28 days post-dose 1

Number of Participants With Adverse Events (AEs)-Post Dose 2

Timeframe: Up to 28 days post-dose 2

Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1

Timeframe: Up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and up to 2 months post-dose 1 for Cohort 5