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Virus Therapy

BNT162b2 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for 7 days after dose 1 and dose 2

Awards & highlights

Study Summary

This trial is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate.

Eligible Conditions

COVID-19
Coronavirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for 7 days after dose 1 and dose 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for 7 days after dose 1 and dose 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and for 7 days after dose 1 and dose 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions

In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events

In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions

+27 more

Secondary outcome measures

Comparison of the SARS-CoV-2 SA strain neutralizing titers after 1 dose of BNT162b2SA to after a third dose of BNT162b2 at 30 µg

Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2

Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals

+19 more

Side effects data

From 2021 Phase 4 trial • 160 Patients • NCT04588480

92%

Injection site pain (PAIN)

63%

Fatigue (FATIGUE)

54%

Headache (HEADACHE)

49%

Chills (CHILLS)

36%

Pyrexia (FEVER)

29%

Arthralgia (JOINT PAIN)

24%

Myalgia (MUSCLE PAIN)

19%

Injection site erythema (REDNESS)

16%

Injection site swelling (SWELLING)

Diarrhoea (DIARRHEA)

Nasopharyngitis

Headache

Pyrexia

Pneumonia

Ovarian neoplasm

100%

80%

60%

40%

20%

Study treatment Arm

BNT162b2

Placebo

Placebo Then BNT162b2

Trial Design

20Treatment groups

Experimental Treatment

Placebo Group

Group I: Vaccination of placebo recipients with BNT162b2 - Stage 2Experimental Treatment1 Intervention

Participants ≥16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.

Group II: Vaccination of Placebo recipients with BNT162b2 - Stage 1Experimental Treatment1 Intervention

Participants ≥16 years of age who originally received placebo and are eligible for COVID-19 vaccination following any local or national recommendations will be offered the opportunity to receive BNT162b2 as part of the study.

Group III: Vaccination of BNT162b2-naive participants with BNT162b2SA at a dose of 30 µgExperimental Treatment1 Intervention

Group IV: Booster vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µgExperimental Treatment1 Intervention

Group V: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 5 µgExperimental Treatment1 Intervention

Group VI: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 30 µgExperimental Treatment1 Intervention

Group VII: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 10 µgExperimental Treatment1 Intervention

Group VIII: Booster vaccination of Phase 1 participants with BNT162b2 at a dose of 30 µgExperimental Treatment1 Intervention

Group IX: Booster and further vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µgExperimental Treatment1 Intervention

Group X: 30 µg dose, ≥12 years of age (2 doses)Experimental Treatment1 Intervention

Group XI: 30 µg dose, 65-85 years of age (2 doses)Experimental Treatment2 Interventions

Group XII: 30 µg dose, 18-55 years of age (2 doses)Experimental Treatment2 Interventions

Group XIII: 20 µg dose, 65-85 years of age (2 doses)Experimental Treatment2 Interventions

Group XIV: 20 µg dose, 18-55 years of age (2 doses)Experimental Treatment2 Interventions

Group XV: 100 µg dose, 18-55 years of age (2 doses)Experimental Treatment1 Intervention

Group XVI: 10 µg dose, 65-85 years of age (2 doses)Experimental Treatment2 Interventions

Group XVII: 10 µg dose, 18-55 years of age (2 doses)Experimental Treatment2 Interventions

Group XVIII: Placebo, 65-85 years of agePlacebo Group1 Intervention

Group XIX: Placebo, ≥12 years of agePlacebo Group1 Intervention

Group XX: Placebo, 18-55 years of agePlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BNT162b1

2020

Completed Phase 3

~47230

BNT162b2

2020

Completed Phase 4

~91490

BNT162b2SA

2020

Completed Phase 3

~47080

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor

64 Previous Clinical Trials

61,484 Total Patients Enrolled

20 Trials studying COVID-19

51,460 Patients Enrolled for COVID-19

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,860,809 Total Patients Enrolled

67 Trials studying COVID-19

1,391,574 Patients Enrolled for COVID-19

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,041,977 Total Patients Enrolled

49 Trials studying COVID-19

1,380,351 Patients Enrolled for COVID-19

Frequently Asked Questions

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

What are researchers hoping to discover through this clinical trial?

"The primary goal for this study is to compare the rate of systemic events in individuals who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs. Additionally, this study will monitor for confirmed cases of severe COVID-19, and compare SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2."

Answered by AI

Are there pre-existing data sets for BNT162b2?

"BNT162b2 was first researched in 2020 by a Contract Research Organization. Since then, there have been 18252 completed studies. 29 of these studies are still recruiting patients, with a significant portion of these trials taking place in Cincinnati, Ohio."

Answered by AI

In how many different waiting rooms will patients sit for this study?

"To limit the inconvenience to participants, the researchers chose 6 locations for this clinical trial, situated in Cincinnati, Fargo, Durham and 6 other cities."

Answered by AI

How many people are in this experiment?

"This particular trial is not recruiting at this time, however, there are 29 trials for BNT162b2 and 1145 trials for covid-19 that are."

Answered by AI

Has this research been conducted before?

"As of right now, there are 29 ongoing trials for BNT162b2 in 220 cities and 27 countries. The first trial was held in 2020 and, BioNTech SE, the sponsor, 512 people completed Phase 1 & 2. Since then, 18252 other trials have been completed."

Answered by AI

Are investigators still looking for subjects to enroll in this research?

"At the moment, this particular study is not looking for any more volunteers. The trial was initially posted on April 29th, 2020 but was last updated on October 13th, 2020. There are 1145 other trials concerning covid-19 and 29 involving BNT162b2 that are currently looking for patients."

Answered by AI

Recent research and studies

NatureJournal

Bnt162b Vaccines Protect Rhesus Macaques from Sars-cov-2

Vogel, Annette B., Isis Kanevsky, Ye Che, Kena A. Swanson, Alexander Muik, Mathias Vormehr, Lena M. Kranz, et al.. 2021. “Bnt162b Vaccines Protect Rhesus Macaques from Sars-cov-2”. Nature. Springer Science and Business Media LLC. doi:10.1038/s41586-021-03275-y.

New England Journal of MedicineJournal

Safety and Efficacy of the Bnt162b2 Mrna Covid-19 Vaccine

Polack, Fernando P., Stephen J. Thomas, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, John L. Perez, et al.. 2020. “Safety and Efficacy of the Bnt162b2 Mrna Covid-19 Vaccine”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2034577.

New England Journal of MedicineJournal

Safety, Immunogenicity, and Efficacy of the Bnt162b2 Covid-19 Vaccine in Adolescents

Frenck, Robert W., Jr., Nicola P. Klein, Nicholas Kitchin, Alejandra Gurtman, Judith Absalon, Stephen Lockhart, John L. Perez, et al.. 2021. “Safety, Immunogenicity, and Efficacy of the Bnt162b2 Covid-19 Vaccine in Adolescents”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2107456.

New England Journal of MedicineJournal