Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

Sponsor
BioNTech SE (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04368728
Collaborator
Pfizer (Industry)
43,998
Enrollment
166
Locations
20
Arms
45.3
Anticipated Duration (Months)
265
Patients Per Site
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.

The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part.

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:
  • As a 2-dose (separated by 21 days) schedule;

  • At various different dose levels in Phase 1;

  • As a booster;

  • In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]).

The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg.

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

In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity.

The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg.

To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days.

To reflect current and anticipated recommendations for COVID 19 vaccine boosters, participants in C4591001 who meet specified recommendations and have not already received one, will be offered a third dose of BNT162b2 after their second dose of BNT162.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: BNT162b1
  • Biological: BNT162b2
  • Other: Placebo
  • Biological: BNT162b2SA
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
43998 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS
Actual Study Start Date :
Apr 29, 2020
Anticipated Primary Completion Date :
Feb 8, 2024
Anticipated Study Completion Date :
Feb 8, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: 10 µg dose, 18-55 years of age (2 doses)

Biological: BNT162b1
Intramuscular injection

Biological: BNT162b2
Intramuscular injection

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

Biological: BNT162b1
Intramuscular injection

Biological: BNT162b2
Intramuscular injection

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

Biological: BNT162b1
Intramuscular injection

Biological: BNT162b2
Intramuscular injection

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

Biological: BNT162b1
Intramuscular injection

Biological: BNT162b2
Intramuscular injection

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

Biological: BNT162b1
Intramuscular injection

Biological: BNT162b2
Intramuscular injection

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

Biological: BNT162b1
Intramuscular injection

Biological: BNT162b2
Intramuscular injection

Experimental: 30 µg dose, ≥12 years of age (2 doses)

Biological: BNT162b2
Intramuscular injection

Placebo Comparator: Placebo, 18-55 years of age

Other: Placebo
Intramuscular injection

Placebo Comparator: Placebo, 65-85 years of age

Other: Placebo
Intramuscular injection

Placebo Comparator: Placebo, ≥12 years of age

Other: Placebo
Intramuscular injection

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

Biological: BNT162b1
Intramuscular injection

Other: Vaccination of Placebo recipients with BNT162b2 - Stage 1

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.

Biological: BNT162b2
Intramuscular injection

Other: Vaccination of placebo recipients with BNT162b2 - Stage 2

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.

Biological: BNT162b2
Intramuscular injection

Experimental: Booster vaccination of Phase 1 participants with BNT162b2 at a dose of 30 µg

Biological: BNT162b2
Intramuscular injection

Experimental: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 30 µg

Biological: BNT162b2
Intramuscular injection

Experimental: Booster vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg

Biological: BNT162b2SA
Intramuscular injection

Experimental: Vaccination of BNT162b2-naive participants with BNT162b2SA at a dose of 30 µg

Biological: BNT162b2SA
Intramuscular injection

Experimental: Booster and further vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg

Biological: BNT162b2SA
Intramuscular injection

Experimental: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 5 µg

Biological: BNT162b2
Intramuscular injection

Experimental: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 10 µg

Biological: BNT162b2
Intramuscular injection

Outcome Measures

Primary Outcome Measures

  1. Percentage of participants in Phase 1 reporting local reactions [For 7 days after dose 1 and dose 2]

    Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

  2. Percentage of participants in Phase 1 reporting systemic events [For 7 days after dose 1 and dose 2]

    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

  3. Percentage of participants in Phase 1 reporting adverse events [From dose 1 through 1 month after the last dose]

    As elicited by investigational site staff

  4. Percentage of participants in Phase 1 reporting serious adverse events [From dose 1 through 6 months after the last dose]

    As elicited by investigational site staff

  5. Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [1 day after dose 1]

    As measured at the central laboratory

  6. Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [7 days after dose 1]

    As measured at the central laboratory

  7. Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [7 days after dose 2]

    As measured at the central laboratory

  8. Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [Between baseline and 1 day after dose 1]

    As measured at the central laboratory

  9. Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [Between baseline and 7 days after dose 1]

    As measured at the central laboratory

  10. Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [Between before dose 2 and 7 days after dose 2]

    As measured at the central laboratory

  11. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions [For 7 days after dose 1 and dose 2]

    Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

  12. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events [For 7 days after dose 1 and dose 2]

    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

  13. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events [From dose 1 through 1 month after the last dose]

    As elicited by investigational site staff

  14. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events [From dose 1 through 6 months after the last dose]

    As elicited by investigational site staff

  15. In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions [For 7 days after dose 1 and dose 2]

    Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

  16. In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events [For 7 days after dose 1 and dose 2]

    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

  17. Percentage of participants in Phase 2/3 reporting adverse events [From dose 1 through 1 month after the last dose]

    As elicited by investigational site staff

  18. Percentage of participants in Phase 2/3 reporting serious adverse events [From dose 1 through 6 months after the last dose]

    As elicited by investigational site staff

  19. Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [From 7 days after the second dose of study intervention to the end of the study, up to 2 years]

    Per 1000 person-years of follow-up

  20. Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [From 7 days after the second dose of study intervention to the end of the study, up to 2 years]

    Per 1000 person-years of follow-up

  21. Percentage of participants 12-15 years of age in Phase 3 reporting adverse events [From dose 1 through 1 month after the last dose]

    As elicited by investigational site staff

  22. Percentage of participants 12-15 years of age in Phase 3 reporting adverse events [From dose 1 through 6 months after the last dose]

    As elicited by investigational site staff

  23. In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions [For 7 days after dose 1 and dose 2]

    Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

  24. In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events [For 7 days after dose 1 and dose 2]

    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

  25. In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting adverse events [From dose 1 through 1 month after the last dose]

    As elicited by investigational site staff

  26. In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting serious adverse events [From dose 1 through 5 or 6 months after the last dose]

    As elicited by investigational site staff

  27. In participants, who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting local reactions [For 7 days after dose 1 (and dose 2)]

    Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

  28. In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting systemic events [For 7 days after dose 1 (and dose 2)]

    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

  29. In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting adverse events [From the third dose through 1 month after the third dose]

    As elicited by investigational site staff

  30. In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting serious adverse events [From the third dose through 6 months after the third dose]

    As elicited by investigational site staff

  31. In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting local reactions [For 7 days after the third dose]

    Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

  32. In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting systemic events [For 7 days after the third dose]

    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

  33. In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting adverse events [From the third dose through 1 month after the third dose]

    As elicited by investigational site staff

  34. In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting serious adverse events [From the third dose through 6 months after the third dose]

    As elicited by investigational site staff

  35. Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to after 2 doses of BNT162b2, in the same individuals [1 month after the third dose]

    As measured at the central laboratory

  36. Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after one dose of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals [1 month after the third dose]

    As measured at the central laboratory

  37. Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2 [1 month after the second dose]

    As measured at the central laboratory

Secondary Outcome Measures

  1. In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [Through 2 years after the final dose]

    As measured at the central laboratory

  2. In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point [Through 2 years after the final dose]

    As measured at the central laboratory

  3. Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels [Through 2 years after the final dose]

    As measured at the central laboratory

  4. In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs [Through 2 years after the final dose]

    As measured at the central laboratory

  5. Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels [Through 2 years after the final dose]

    As measured at the central laboratory

  6. In Phase 1 participants, GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels from before vaccination to each subsequent time point [Through 2 years after the final dose]

    As measured at the central laboratory

  7. In Phase 1 participants, GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 (anti-S1 and anti-RBD) binding antibody levels [Through 2 years after the final dose]

    As measured at the central laboratory

  8. Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [From 14 days after the second dose of study intervention to the end of the study, up to 2 years]

    Per 1000 person-years of follow-up

  9. Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [From 14 days after the second dose of study intervention to the end of the study, up to 2 years]

    Per 1000 person-years of follow-up

  10. Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [From 7 days after the second dose of study intervention to the end of the study, up to 2 years]

    Per 1000 person-years of follow-up

  11. Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [From 14 days after the second dose of study intervention to the end of the study, up to 2 years]

    Per 1000 person-years of follow-up

  12. Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [From 7 days after the second dose of study intervention to the end of the study, up to 2 years]

    Per 1000 person-years of follow-up

  13. Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [From 14 days after the second dose of study intervention to the end of the study, up to 2 years]

    Per 1000 person-years of follow-up

  14. Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination [From 7 days after the second dose of study intervention to the end of the study, up to 2 years]

    Per 1000 person-years of follow-up

  15. Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination [From 14 days after the second dose of study intervention to the end of the study, up to 2 years]

    Per 1000 person-years of follow-up

  16. Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination [From 7 days after the second dose of study intervention to the end of the study, up to 2 years]

    Per 1000 person-years of follow-up

  17. Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination [From 14 days after the second dose of study intervention to the end of the study, up to 2 years]

    Per 1000 person-years of follow-up

  18. GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age) [1 month after the second dose]

    As measured at the central laboratory

  19. Incidence of asymptomatic SARS CoV-2 infection based on N binding antibody seroconversion in participants with no serological or virological evidence of past SARS CoV-2 infection or confirmed COVID-19 prior to 1 month after receipt of the second dose [Through 1 month after the second dose]

    Per 1000 person-years of follow-up

  20. Incidence of asymptomatic SARS CoV-2 infection based on central laboratory-confirmed NAAT in participants with no serological or virological evidence (up to the start of the asymptomatic surveillance period) of past SARS-CoV-2 infection [Through 6 months after the second dose]

    Per 1000 person-years of follow-up

  21. Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals [1 month after the third dose]

    As measured at the central laboratory

  22. Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after one dose of BNT162b2SA compared to after 2 doses of BNT162b2, in the same individuals [1 month after the first dose of BNT162b2SA]

    As measured at the central laboratory

  23. 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 [1 month after the first dose of BNT162b2SA/third dose of BNT162b2]

    As measured at the central laboratory

  24. 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 [1 month after the second dose of BNT162b2SA]

    As measured at the central laboratory

  25. Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2 [1 month after the second dose]

    As measured at the central laboratory

  26. Comparison of the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2 [1 month after the second dose]

    As measured at the central laboratory

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

• Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥12 years, inclusive, at randomization (dependent upon study phase). For the boostability and protection-against-VOCs subset: Existing participants enrolled to receive a third dose of BNT162b2 at 30 µg or BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at rerandomization.

Newly enrolled participants enrolled to receive 2 doses of BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at enrollment.

Existing participants enrolled to receive a third dose of BNT162b2 at 5 or 10 µg; male or female participants ≥18 years at rerandomization.

Note that participants <18 years of age cannot be enrolled in the EU.

  • Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.

  • Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.

  • Participants who, in the judgment of the investigator, are at risk for acquiring COVID-19.

  • Boostability and protection-against-VOCs existing participant subset only: Participants who provided a serum sample at Visit 3, with Visit 3 occurring within the protocol-specified window.

  • Capable of giving personal signed informed consent

Exclusion Criteria:
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

  • Phases 1 and 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).

  • Receipt of medications intended to prevent COVID 19.

  • Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19

  • Phase 1 only: Individuals at high risk for severe COVID-19, including those with any of the following risk factors:

  • Hypertension

  • Diabetes mellitus

  • Chronic pulmonary disease

  • Asthma

  • Current vaping or smoking

  • History of chronic smoking within the prior year

  • BMI >30 kg/m2

  • Anticipating the need for immunosuppressive treatment within the next 6 months

  • Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel).

  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

  • Phase 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.

  • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.

  • Women who are pregnant or breastfeeding.

  • Previous vaccination with any coronavirus vaccine.

  • Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.

  • Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids.

  • Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.

  • Participation in other studies involving study intervention within 28 days prior to study entry through and including 6 months after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID 19, which are prohibited throughout study participation.

  • Previous participation in other studies involving study intervention containing lipid nanoparticles.

  • Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit.

  • Phase 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.

  • Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit.

  • Phase 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention.

  • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1North Alabama Research Center, LLCAthensAlabamaUnited States35611
2Birmingham Clinical Research UnitBirminghamAlabamaUnited States35216
3Medical Affiliated Research CenterHuntsvilleAlabamaUnited States35801
4Optimal Research, LLCHuntsvilleAlabamaUnited States35802
5Alliance for Multispecialty Research, LLCMobileAlabamaUnited States36608
6Chinle Comprehensive Health Care FacilityChinleArizonaUnited States86503
7Johns Hopkins Center for American Indian HealthChinleArizonaUnited States86503
8The Pain Center of ArizonaPhoenixArizonaUnited States85018
9HOPE Research InstitutePhoenixArizonaUnited States85023
10Alliance for Multispecialty Research, LLCTempeArizonaUnited States85281
11Whiteriver Indian HospitalWhiteriverArizonaUnited States85941
12Anaheim Clinical Trials, LLCAnaheimCaliforniaUnited States92801
13Collaborative Neuroscience Research, LLCLong BeachCaliforniaUnited States90806
14Long Beach Clinical Trials Services Inc.Long BeachCaliforniaUnited States90806
15Kaiser Permanente Los Angeles Medical CenterLos AngelesCaliforniaUnited States90027
16National Research InstituteLos AngelesCaliforniaUnited States90057
17Providence Clinical ResearchNorth HollywoodCaliforniaUnited States91606
18Paradigm Clinical Research CenterReddingCaliforniaUnited States96001
19Kaiser Permanente SacramentoSacramentoCaliforniaUnited States95815
20UC Davis Medical CenterSacramentoCaliforniaUnited States95817
21California Research FoundationSan DiegoCaliforniaUnited States92123-1881
22Kaiser Permanente Santa ClaraSanta ClaraCaliforniaUnited States95051
23Bayview Research GroupValley VillageCaliforniaUnited States91607
24Diablo Clinical Research, Inc.Walnut CreekCaliforniaUnited States94598
25Lynn Institute of DenverAuroraColoradoUnited States80012
26Clinical Research Consulting, LLCMilfordConnecticutUnited States06460
27Yale Center for Clinical Investigations (CSRU)New HavenConnecticutUnited States06519
28Alliance for Multispecialty ResearchCoral GablesFloridaUnited States33134
29DeLand Clinical Research UnitDeLandFloridaUnited States32720
30Fleming Island Center for Clinical ResearchFleming IslandFloridaUnited States32003
31Indago Research & Health Center, Inc.HialeahFloridaUnited States33012
32Research Centers of AmericaHollywoodFloridaUnited States33024
33Jacksonville Center for Clinical ResearchJacksonvilleFloridaUnited States32216
34Clinical Neuroscience Solutions, Inc.JacksonvilleFloridaUnited States32256
35Acevedo Clinical Research AssociatesMiamiFloridaUnited States33142
36Clinical Neuroscience Solutions, IncOrlandoFloridaUnited States32801
37Atlanta Center for Medical ResearchAtlantaGeorgiaUnited States30331
38IACT HealthColumbusGeorgiaUnited States31904
39Meridian Clinical Research, LLCSavannahGeorgiaUnited States31406
40Clinical Research AtlantaStockbridgeGeorgiaUnited States30281
41East-West Medical Research InstituteHonoluluHawaiiUnited States96814
42Solaris Clinical ResearchMeridianIdahoUnited States83646
43Optimal Research, LLCPeoriaIllinoisUnited States61614
44University of Iowa Hospitals & Clinics Investigational Drug ServcesIowa CityIowaUnited States42242
45University of Iowa Hospitals & ClinicsIowa CityIowaUnited States52242
46Meridian Clinical ResearchSioux CityIowaUnited States51106
47Alliance for Multispecialty Research, LLCNewtonKansasUnited States67114
48Alliance for Multispecialty Research, LLCWichitaKansasUnited States67207
49Kentucky Pediatric/ Adult ResearchBardstownKentuckyUnited States40004
50Benchmark ResearchMetairieLouisianaUnited States70006
51Ochsner Clinic FoundationNew OrleansLouisianaUnited States70121
52LSU Health Sciences Center at Shreveport Clinical Trials OfficeShreveportLouisianaUnited States71101
53LSUHSC-ShreveportShreveportLouisianaUnited States71103
54Pharmaron CPC, Inc.BaltimoreMarylandUnited States21201
55University of Maryland Medical Center Investigational Drug Service PharmacyBaltimoreMarylandUnited States21201
56University of Maryland, Baltimore, Health Sciences Research Facility IIIBaltimoreMarylandUnited States21201
57University of Maryland, Center for Vaccine Development and Global HealthBaltimoreMarylandUnited States21201
58Johns Hopkins Bayview Medical CenterBaltimoreMarylandUnited States21224
59Boston Medical CenterBostonMassachusettsUnited States02118
60Investigational Pharmacy ServiceBostonMassachusettsUnited States02118
61UMass Memorial Medical Center - University CampusWorcesterMassachusettsUnited States01655
62Michigan Center for Medical ResearchFarmington HillsMichiganUnited States48334
63MedPharmics, Limited Liability CompanyGulfportMississippiUnited States39503
64MedPharmics, LLCGulfportMississippiUnited States39503
65Clinical Research ProfessionalsChesterfieldMissouriUnited States63005
66Sundance Clinical Research, LLCSaint LouisMissouriUnited States63141
67Bozeman Health Deaconess Hospital dba Bozeman Health Clinical ResearchBozemanMontanaUnited States59715
68Bozeman Health Deaconess HospitalBozemanMontanaUnited States59715
69Methodist Physicians Clinic / CCT ResearchFremontNebraskaUnited States68025
70Meridian Clinical ResearchNorfolkNebraskaUnited States68701
71Quality Clinical Research, Inc.OmahaNebraskaUnited States68114
72Meridian Clinical Research, LLCOmahaNebraskaUnited States68134
73Wake Research-Clinical Research Center of Nevada, LLCLas VegasNevadaUnited States89106
74Amici Clinical ResearchRaritanNew JerseyUnited States08869
75South Jersey Infectious DiseaseSomers PointNew JerseyUnited States08244
76Johns Hopkins Center for American Indian HealthGallupNew MexicoUnited States87301
77Johns Hopkins Center for American Indian HealthShiprockNew MexicoUnited States87420
78Meridian Clinical Research, LLCBinghamtonNew YorkUnited States13901
79Meridian Clinical Research LLCEndwellNew YorkUnited States13760
80NYU Langone HealthNew YorkNew YorkUnited States10016
81Icahn School of Medicine at Mount SinaiNew YorkNew YorkUnited States10029
82Rochester Clinical Research, Inc.RochesterNew YorkUnited States14609
83Rochester Regional Health/Rochester General HospitalRochesterNew YorkUnited States14621
84SUNY Upstate Medical University Global Health Research UnitSyracuseNew YorkUnited States13215
85PMG Research of Raleigh, LLC d/b/a PMG Research of CaryCaryNorth CarolinaUnited States27518
86PMG Research of Charlotte LLCCharlotteNorth CarolinaUnited States28209
87Clinical Research Pickett RoadDurhamNorth CarolinaUnited States27705
88Accessioning Unit and RepositoryDurhamNorth CarolinaUnited States27710
89Duke Investigational Drug Service PharmacyDurhamNorth CarolinaUnited States27710
90Duke University Medicine Circle- Duke Early Phase Clinical Research UnitDurhamNorth CarolinaUnited States27710
91PharmQuestGreensboroNorth CarolinaUnited States27408
92PMG Research of Hickory, LLCHickoryNorth CarolinaUnited States28601
93PMG Research of Raleigh, LLCRaleighNorth CarolinaUnited States27609
94M3 Wake Research, Inc.RaleighNorth CarolinaUnited States27612
95PMG Research of Salisbury, LLCSalisburyNorth CarolinaUnited States28144
96PMG Research of Wilmington, LLCWilmingtonNorth CarolinaUnited States28401
97PMG Research of Winston-Salem, LLCWinston-SalemNorth CarolinaUnited States27103
98Lillestol Research LlcFargoNorth DakotaUnited States58104
99Sterling Research Group, Ltd.CincinnatiOhioUnited States45219
100Cincinnati Children's Hospital Medical CenterCincinnatiOhioUnited States45229-3039
101Sterling Research Group, Ltd.CincinnatiOhioUnited States45246
102University Hospitals Cleveland Medical CenterClevelandOhioUnited States44106
103VA Northeast Ohio Healthcare SystemClevelandOhioUnited States44106
104Velocity Clinical Research, Inc.ClevelandOhioUnited States44122
105Aventiv Research Inc.ColumbusOhioUnited States43213
106Dayton Clinical ResearchDaytonOhioUnited States45406
107PriMED Clinical ResearchDaytonOhioUnited States45419
108Senders PediatricsSouth EuclidOhioUnited States44121
109Lynn Institute of NormanNormanOklahomaUnited States73072
110Kaiser Permanente Northwest-Center for Health ResearchPortlandOregonUnited States97227
111Lehigh Valley Health Network/Network Office of Research and InnovationAllentownPennsylvaniaUnited States18102
112Velocity Clinical Research, ProvidenceEast GreenwichRhode IslandUnited States02818
113Main Street Physician's CareLittle RiverSouth CarolinaUnited States29566
114Main Street Physician's CareLorisSouth CarolinaUnited States29569
115Holston Medical GroupBristolTennesseeUnited States37620
116Holston Medical GroupKingsportTennesseeUnited States37660
117Alliance for Multispecialty Research, LLCKnoxvilleTennesseeUnited States37909
118Alliance for Multispecialty Research, LLCKnoxvilleTennesseeUnited States37920
119Clinical Neuroscience Solutions, Inc.MemphisTennesseeUnited States38119
120Clinical Research Associates, Inc.NashvilleTennesseeUnited States37203
121Trinity Clinical ResearchTullahomaTennesseeUnited States37388
122Benchmark ResearchAustinTexasUnited States78705
123ARC Clinical Research at Wilson ParkeAustinTexasUnited States78726
124Tekton Research, Inc.AustinTexasUnited States78745
125North Texas Infectious Diseases Consultants, P.A.DallasTexasUnited States75246
126Ventavia Research Group, LLCFort WorthTexasUnited States76104
127Benchmark ResearchFort WorthTexasUnited States76135
128Texas Health ResourcesFort WorthTexasUnited States76135
129University of Texas Medical BranchGalvestonTexasUnited States77555
130Ventavia Research Group, LLCHoustonTexasUnited States77008
131Texas Center for Drug Development, Inc.HoustonTexasUnited States77081
132Ventavia Research Group, LLCKellerTexasUnited States76248
133SMS Clinical Research, LLCMesquiteTexasUnited States75149
134LinQ Research, LLCPearlandTexasUnited States77584
135Benchmark Research.San AngeloTexasUnited States76904
136Clinical Trials of Texas, Inc.San AntonioTexasUnited States78229
137Diagnostics Research GroupSan AntonioTexasUnited States78229
138Martin Diagnostic ClinicTomballTexasUnited States77375
139J. Lewis Research, Inc. / Foothill Family ClinicSalt Lake CityUtahUnited States84109
140J. Lewis Research, Inc. / Foothill Family Clinic SouthSalt Lake CityUtahUnited States84121
141Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)AnnandaleVirginiaUnited States22003
142Virginia Research Center LLCMidlothianVirginiaUnited States23114
143Benaroya Research Institute at Virginia MasonSeattleWashingtonUnited States98101
144Wenatchee Valley HospitalWenatcheeWashingtonUnited States98801
145Hospital Militar Central Cirujano Mayor Dr. Cosme ArgerichCabaArgentina1426
146Hospital Santo Antonio/ Associacao Obras Sociais Irma DulceSalvadorBahiaBrazilCEP: 40415-006
147CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda (Casa Branca)Sao PauloBrazil04266-010
148CRS Clinical Research Services Berlin GmbHBerlinGermany13353
149Medizentrum Essen BorbeckEssenGermany45355
150IKF Pneumologie GmbH & Co KGFrankfurt am MainGermany60596
151Universitätsklinikum Hamburg-EppendorfHamburgGermany20359
152CRS Clinical Research Services Mannheim GmbHMannheimGermany68167
153Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten DrescherStuhrGermany28816
154Newtown Clinical Research CentreJohannesburgGautengSouth Africa2113
155Jongaie ResearchPretoriaGautengSouth Africa0183
156Limpopo Clinical Research InitiativeThabazimbiLimpopoSouth Africa0380
157Tiervlei Trial Centre, Basement Level, Karl Bremer HospitalCape TownWestern CAPESouth Africa7530
158Ankara Universitesi Tip Fakultesi, Ibni Sina HastanesiAnkaraTurkey06230
159Hacettepe Universitesi Tip FakultesiAnkaraTurkey06230
160Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma HastanesiIstanbulTurkey34020
161Istanbul Universitesi Istanbul Tip FakultesiIstanbulTurkey34093
162Istanbul Universitesi-Cerrahpasa, Cerrahpasa Tip FakultesiIstanbulTurkey34098
163Medipol Mega Universite HastanesiIstanbulTurkey34214
164Acibadem Atakent HastanesiIstanbulTurkey34303
165Kocaeli Universitesi Tip FakultesiKocaeliTurkey41380
166Sakarya Universitesi Egitim ve Arastirma HastanesiSakaryaTurkey54100

Sponsors and Collaborators

  • BioNTech SE
  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
BioNTech SE
ClinicalTrials.gov Identifier:
NCT04368728
Other Study ID Numbers:
  • C4591001
  • 2020-002641-42
First Posted:
Apr 30, 2020
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by BioNTech SE
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2022