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

NCT04368728

Last updated date
Study Location
North Alabama Research Center, LLC
Athens, Alabama, 35611, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
SARS-CoV-2 Infection, COVID-19
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study phase). - 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. - Capable of giving personal signed informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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. - 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 or microbiological 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 and/or during 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.


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SARS-CoV-2 Infection, COVID-19Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults
NCT04368728_0
  1. Athens, Alabama
  2. Walnut Creek, California
  3. Hollywood, Florida
  4. Orlando, Florida
  5. Savannah, Georgia
  6. Stockbridge, Georgia
  7. Bardstown, Kentucky
  8. Boston, Massachusetts
  9. Boston, Massachusetts
  10. Saint Louis, Missouri
  11. Norfolk, Nebraska
  12. Omaha, Nebraska
  13. Rochester, New York
  14. Raleigh, North Carolina
  15. Wilmington, North Carolina
  16. Columbus, Ohio
  17. Austin, Texas
  18. Fort Worth, Texas
  19. Houston, Texas
  20. Salt Lake City, Utah
  21. Salt Lake City, Utah
  22. Baltimore, Maryland
  23. New York, New York
  24. Rochester, New York
  25. Cincinnati, Ohio
  26. Cincinnati, Ohio
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SARS-CoV-2 Infection, COVID-19Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults
NCT04368728
  1. Birmingham, Alabama
  2. Huntsville, Alabama
  3. Garden Grove, California
  4. Long Beach, California
  5. Los Angeles, California
  6. Sacramento, California
  7. Sacramento, California
  8. Valley Village, California
  9. New Haven, Connecticut
  10. New Haven, Connecticut
  11. New Haven, Connecticut
  12. Hialeah, Florida
  13. Shreveport, Louisiana
  14. Shreveport, Louisiana
  15. Baltimore, Maryland
  16. Worcester, Massachusetts
  17. Worcester, Massachusetts
  18. Gulfport, Mississippi
  19. Fremont, Nebraska
  20. New York, New York
  21. New York, New York
  22. Greensboro, North Carolina
  23. Cincinnati, Ohio
  24. Cleveland, Ohio
  25. Cleveland, Ohio
  26. Cleveland, Ohio
  27. Dayton, Ohio
  28. South Euclid, Ohio
  29. Portland, Oregon
  30. Allentown, Pennsylvania
  31. Bristol, Tennessee
  32. Nashville, Tennessee
  33. Austin, Texas
  34. Houston, Texas
  35. Mesquite, Texas
  36. Annandale, Virginia
  37. Annandale, Virginia
  38. Seattle, Washington
  39. Salvador, BA
  40. Ankara,
  41. Athens, Alabama
  42. Huntsville, Alabama
  43. Mobile, Alabama
  44. Phoenix, Arizona
  45. Phoenix, Arizona
  46. Phoenix, Arizona
  47. Tempe, Arizona
  48. Anaheim, California
  49. Long Beach, California
  50. Los Angeles, California
  51. North Hollywood, California
  52. Redding, California
  53. San Diego, California
  54. Santa Clara, California
  55. Walnut Creek, California
  56. Aurora, Colorado
  57. Milford, Connecticut
  58. Coral Gables, Florida
  59. DeLand, Florida
  60. Fleming Island, Florida
  61. Hollywood, Florida
  62. Jacksonville, Florida
  63. Jacksonville, Florida
  64. Miami, Florida
  65. Orlando, Florida
  66. Atlanta, Georgia
  67. Columbus, Georgia
  68. Savannah, Georgia
  69. Stockbridge, Georgia
  70. Honolulu, Hawaii
  71. Meridian, Idaho
  72. Peoria, Illinois
  73. Iowa City, Iowa
  74. Iowa City, Iowa
  75. Newton, Kansas
  76. Wichita, Kansas
  77. Bardstown, Kentucky
  78. Metairie, Louisiana
  79. New Orleans, Louisiana
  80. Baltimore, Maryland
  81. Baltimore, Maryland
  82. Boston, Massachusetts
  83. Boston, Massachusetts
  84. Farmington Hills, Michigan
  85. Chesterfield, Missouri
  86. Saint Louis, Missouri
  87. Bozeman, Montana
  88. Norfolk, Nebraska
  89. Omaha, Nebraska
  90. Omaha, Nebraska
  91. Las Vegas, Nevada
  92. Raritan, New Jersey
  93. Somers Point, New Jersey
  94. Binghamton, New York
  95. Endwell, New York
  96. New York, New York
  97. Rochester, New York
  98. Rochester, New York
  99. Syracuse, New York
  100. Cary, North Carolina
  101. Charlotte, North Carolina
  102. Durham, North Carolina
  103. Durham, North Carolina
  104. Durham, North Carolina
  105. Hickory, North Carolina
  106. Raleigh, North Carolina
  107. Raleigh, North Carolina
  108. Salisbury, North Carolina
  109. Wilmington, North Carolina
  110. Winston-Salem, North Carolina
  111. Fargo, North Dakota
  112. Cincinnati, Ohio
  113. Cincinnati, Ohio
  114. Cincinnati, Ohio
  115. Columbus, Ohio
  116. Dayton, Ohio
  117. Norman, Oklahoma
  118. Warwick, Rhode Island
  119. Little River, South Carolina
  120. Loris, South Carolina
  121. Dakota Dunes, South Dakota
  122. Kingsport, Tennessee
  123. Knoxville, Tennessee
  124. Memphis, Tennessee
  125. Tullahoma, Tennessee
  126. Austin, Texas
  127. Austin, Texas
  128. Dallas, Texas
  129. Fort Worth, Texas
  130. Fort Worth, Texas
  131. Fort Worth, Texas
  132. Galveston, Texas
  133. Houston, Texas
  134. Houston, Texas
  135. Houston, Texas
  136. Keller, Texas
  137. Pearland, Texas
  138. San Angelo, Texas
  139. San Angelo, Texas
  140. San Antonio, Texas
  141. San Antonio, Texas
  142. Tomball, Texas
  143. Tomball, Texas
  144. Salt Lake City, Utah
  145. Salt Lake City, Utah
  146. Midlothian, Virginia
  147. Wenatchee, Washington
  148. Caba,
  149. São Paulo,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults
Official Title  ICMJE 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 ADULTS
Brief Summary

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

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

The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • SARS-CoV-2 Infection
  • COVID-19
Intervention  ICMJE
  • Biological: BNT162b1
    Intramuscular injection
  • Biological: BNT162b2
    Intramuscular injection
  • Other: Placebo
    Intramuscular injection
Study Arms  ICMJE
  • Experimental: Low dose, 18-55 years of age (2 doses)
    Interventions:
    • Biological: BNT162b1
    • Biological: BNT162b2
  • Experimental: Low-mid dose, 18-55 years of age (2 doses)
    Interventions:
    • Biological: BNT162b1
    • Biological: BNT162b2
  • Experimental: Mid dose, 18-55 years of age (2 doses)
    Interventions:
    • Biological: BNT162b1
    • Biological: BNT162b2
  • Experimental: Low dose, 65-85 years of age (2 doses)
    Interventions:
    • Biological: BNT162b1
    • Biological: BNT162b2
  • Experimental: Low-mid dose, 65-85 years of age (2 doses)
    Interventions:
    • Biological: BNT162b1
    • Biological: BNT162b2
  • Experimental: Mid dose, 65-85 years of age (2 doses)
    Interventions:
    • Biological: BNT162b1
    • Biological: BNT162b2
  • Experimental: Mid dose, 18-85 years of age (2 doses)
    Intervention: Biological: BNT162b2
  • Placebo Comparator: Placebo, 18-55 years of age
    Intervention: Other: Placebo
  • Placebo Comparator: Placebo, 65-85 years of age
    Intervention: Other: Placebo
  • Placebo Comparator: Placebo, 18-85 years of age
    Intervention: Other: Placebo
  • Experimental: High dose, 18-55 years of age (2 doses)
    Intervention: Biological: BNT162b1
Publications * Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Raabe V, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Türeci Ö, Tompkins KR, Walsh EE, Frenck R, Falsey AR, Dormitzer PR, Gruber WC, ?ahin U, Jansen KU. Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults. Nature. 2020 Aug 12. doi: 10.1038/s41586-020-2639-4. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2020)
29481
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2020)
8640
Estimated Study Completion Date  ICMJE November 14, 2022
Estimated Primary Completion Date April 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study phase).
  • 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.
  • 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.
  • 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 or microbiological 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 and/or during 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Argentina,   Brazil,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04368728
Other Study ID Numbers  ICMJE C4591001
2020-002641-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party BioNTech SE
Study Sponsor  ICMJE BioNTech SE
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account BioNTech SE
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP