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
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, 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 stage). - 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. - 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. - Stages 1 and 2 only: Previous clinical or microbiological diagnosis of COVID 19. - Sentinel participants in Stage 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 - Sentinel participants in Stage 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. - Sentinel participants in Stage 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. - Sentinel participants in Stage 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. - Sentinel participants in Stage 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit. - Sentinel participants in Stage 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality. - Sentinel participants in Stage 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. - Sentinel participants in Stage 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. Walnut Creek, California
  2. Hollywood, Florida
  3. Orlando, Florida
  4. Savannah, Georgia
  5. Stockbridge, Georgia
  6. Bardstown, Kentucky
  7. Boston, Massachusetts
  8. Boston, Massachusetts
  9. Saint Louis, Missouri
  10. Norfolk, Nebraska
  11. Omaha, Nebraska
  12. Rochester, New York
  13. Raleigh, North Carolina
  14. Wilmington, North Carolina
  15. Columbus, Ohio
  16. Austin, Texas
  17. Fort Worth, Texas
  18. Houston, Texas
  19. Salt Lake City, Utah
  20. Salt Lake City, Utah
  21. Baltimore, Maryland
  22. New York, New York
  23. Rochester, New York
  24. Cincinnati, Ohio
  25. 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. Phoenix, Arizona
  2. Long Beach, California
  3. Coral Gables, Florida
  4. Newton, Kansas
  5. Dakota Dunes, South Dakota
  6. Caba,
  7. São Paulo,
  8. Mobile, Alabama
  9. Phoenix, Arizona
  10. Phoenix, Arizona
  11. Tempe, Arizona
  12. Anaheim, California
  13. Santa Clara, California
  14. Walnut Creek, California
  15. Coral Gables, Florida
  16. DeLand, Florida
  17. Fleming Island, Florida
  18. Hollywood, Florida
  19. Jacksonville, Florida
  20. Orlando, Florida
  21. Atlanta, Georgia
  22. Savannah, Georgia
  23. Stockbridge, Georgia
  24. Peoria, Illinois
  25. Iowa City, Iowa
  26. Iowa City, Iowa
  27. Wichita, Kansas
  28. Bardstown, Kentucky
  29. Metairie, Louisiana
  30. New Orleans, Louisiana
  31. Baltimore, Maryland
  32. Boston, Massachusetts
  33. Boston, Massachusetts
  34. Saint Louis, Missouri
  35. Norfolk, Nebraska
  36. Omaha, Nebraska
  37. Omaha, Nebraska
  38. Binghamton, New York
  39. Endwell, New York
  40. New York, New York
  41. Rochester, New York
  42. Rochester, New York
  43. Syracuse, New York
  44. Cary, North Carolina
  45. Charlotte, North Carolina
  46. Durham, North Carolina
  47. Durham, North Carolina
  48. Durham, North Carolina
  49. Raleigh, North Carolina
  50. Raleigh, North Carolina
  51. Salisbury, North Carolina
  52. Wilmington, North Carolina
  53. Winston-Salem, North Carolina
  54. Cincinnati, Ohio
  55. Cincinnati, Ohio
  56. Cincinnati, Ohio
  57. Columbus, Ohio
  58. Warwick, Rhode Island
  59. Knoxville, Tennessee
  60. Austin, Texas
  61. Austin, Texas
  62. Fort Worth, Texas
  63. Fort Worth, Texas
  64. Fort Worth, Texas
  65. Galveston, Texas
  66. Houston, Texas
  67. Keller, Texas
  68. San Angelo, Texas
  69. San Angelo, Texas
  70. San Antonio, Texas
  71. San Antonio, Texas
  72. Salt Lake City, Utah
  73. Salt Lake City, Utah
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 * Not Provided

*   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 11, 2022
Estimated Primary Completion Date April 16, 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,   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 August 2020

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