Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults

• ClinicalTrials.gov Identifier: NCT04588480
• Recruitment Status: Completed
• First Posted: October 19, 2020
• Last Update Posted: February 23, 2022
• Sponsor: BioNTech SE
• Collaborator: Pfizer
• Information provided by (Responsible Party): BioNTech SE

Tracking Information

• First Submitted Date: October 14, 2020
• First Posted Date: October 19, 2020
• Last Update Posted Date: February 23, 2022
• Actual Study Start Date: October 21, 2020
• Actual Primary Completion Date: November 25, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 14, 2020)

• Percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ]
  Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
• Percentage of participants reporting systemic events [ Time Frame: 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.
• Percentage of participants reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ]
  As elicited by investigational site staff
• Percentage of participants reporting serious adverse events [ Time Frame: From dose 1 through 12 months after the last dose ]
  As elicited by investigational site staff
• Percentage of subset participants with abnormal hematology and chemistry laboratory values [ Time Frame: 1 day after dose 1 ]
  As measured at the local laboratory
• Percentage of subset participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 1 ]
  As measured at the local laboratory
• Percentage of subset participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 2 ]
  As measured at the local laboratory
• Percentage of subset participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 1 day after dose 1 ]
  As measured at the local laboratory
• Percentage of subset participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 7 days after dose 1 ]
  As measured at the local laboratory
• Percentage of subset participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between before dose 2 and 7 days after dose 2 ]
  As measured at the local laboratory
• SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: 1 month after dose 2 ]
  As measured at the central laboratory
• GMFR in SARS-CoV-2 serum neutralizing titers [ Time Frame: From before vaccination to 1 month after dose 2 ]
  As measured at the central laboratory
• SARS-CoV-2 S1-binding IgG levels, expressed as GMCs [ Time Frame: 1 month after dose 2 ]
  as measured at the central laboratory
• GMFR in SARS-CoV-2 S1-binding IgG levels [ Time Frame: From before vaccination to 1 month after dose 2 ]
  as measured at the central laboratory

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 14, 2020)

• SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: Through 1 year after dose 2 ]
  As measured at the central laboratory
• GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point [ Time Frame: Through 1 year after dose 2 from baseline ]
  As measured at the central laboratory
• SARS-CoV-2 S1-binding IgG levels, expressed as GMCs [ Time Frame: Through 1 year after dose 2 ]
  As measured at the central laboratory
• GMFR in SARS-CoV-2 S1-binding IgG levels from before vaccination to each subsequent time point [ Time Frame: Through 1 year after dose 2 from baseline ]
  As measured at the central laboratory
• GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 S1-binding IgG levels [ Time Frame: Through 1 year after dose 2 ]
  As measured at the central laboratory

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults
• Official Title: A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, AND OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY JAPANESE ADULTS

Brief Summary

This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy Japanese adults.

The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19:

• As 2 doses, separated by 21 days
• At a single dose level
• In adults 20 to 85 years of age

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention

Condition

• SARS-CoV-2 Infection
• COVID-19

Intervention

• Biological: BNT162b2
  BNT162b2 (intramuscular injection)
• Other: Placebo
  Placebo (intramuscular injection)

Study Arms

• Experimental: BNT162b2
  BNT162b2 (intramuscular injection)
  Intervention: Biological: BNT162b2
• Placebo Comparator: Placebo
  Placebo (intramuscular injection)
  Intervention: Other: Placebo

• Publications *: Haranaka M, Baber J, Ogama Y, Yamaji M, Aizawa M, Kogawara O, Scully I, Lagkadinou E, Türeci Ӧ, Şahin U, Dormitzer PR, Gruber WC, Lockhart S. A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults. Nat Commun. 2021 Dec 14;12(1):7105. doi: 10.1038/s41467-021-27316-2.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 14, 2020): 160
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 25, 2021
• Actual Primary Completion Date: November 25, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Japanese male or female participants between the ages of 20 and 85 years, inclusive, at randomization.
• 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:

• 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 confirmed diagnosis of COVID-19.
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• 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.
• 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.
• Subset only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
• 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

• Sexes Eligible for Study: All

• Ages: 20 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT04588480
• Other Study ID Numbers: C4591005
• 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
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: BioNTech SE
• Study Sponsor: BioNTech SE
• Collaborators: Pfizer

Investigators

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

• PRS Account: BioNTech SE
• Verification Date: February 2022