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

Sponsor
BioNTech SE (Industry)
Overall Status
Completed
CT.gov ID
NCT04588480
Collaborator
Pfizer (Industry)
160
2
2
13.1
80
6.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Biological: BNT162b2
  • Other: Placebo
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Oct 21, 2020
Actual Primary Completion Date :
Nov 25, 2021
Actual Study Completion Date :
Nov 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: BNT162b2

BNT162b2 (intramuscular injection)

Biological: BNT162b2
BNT162b2 (intramuscular injection)

Placebo Comparator: Placebo

Placebo (intramuscular injection)

Other: Placebo
Placebo (intramuscular injection)

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

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

    As elicited by investigational site staff

  4. Percentage of participants reporting serious adverse events [From dose 1 through 12 months after the last dose]

    As elicited by investigational site staff

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

    As measured at the local laboratory

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

    As measured at the local laboratory

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

    As measured at the local laboratory

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

    As measured at the local laboratory

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

    As measured at the local laboratory

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

    As measured at the local laboratory

  11. SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [1 month after dose 2]

    As measured at the central laboratory

  12. GMFR in SARS-CoV-2 serum neutralizing titers [From before vaccination to 1 month after dose 2]

    As measured at the central laboratory

  13. SARS-CoV-2 S1-binding IgG levels, expressed as GMCs [1 month after dose 2]

    as measured at the central laboratory

  14. GMFR in SARS-CoV-2 S1-binding IgG levels [From before vaccination to 1 month after dose 2]

    as measured at the central laboratory

Secondary Outcome Measures

  1. SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [Through 1 year after dose 2]

    As measured at the central laboratory

  2. GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point [Through 1 year after dose 2 from baseline]

    As measured at the central laboratory

  3. SARS-CoV-2 S1-binding IgG levels, expressed as GMCs [Through 1 year after dose 2]

    As measured at the central laboratory

  4. GMFR in SARS-CoV-2 S1-binding IgG levels from before vaccination to each subsequent time point [Through 1 year after dose 2 from baseline]

    As measured at the central laboratory

  5. GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 S1-binding IgG levels [Through 1 year after dose 2]

    As measured at the central laboratory

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 SOUSEIKAI Sumida Hospital Sumida-ku Tokyo Japan 130-0004
2 SOUSEIKAI PS Clinic Fukuoka Japan 812-0025

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:
NCT04588480
Other Study ID Numbers:
  • C4591005
First Posted:
Oct 19, 2020
Last Update Posted:
Feb 23, 2022
Last Verified:
Feb 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
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2022