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: Active, not recruiting
• First Posted: October 19, 2020
• Last Update Posted: August 18, 2021
• Sponsor: BioNTech SE
• Collaborator: Pfizer
• Information provided by (Responsible Party): BioNTech SE

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
SARS-CoV-2 Infection; COVID-19	Biological: BNT162b2; Other: Placebo	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: October 21, 2020
• Estimated Primary Completion Date: November 24, 2021
• Estimated Study Completion Date: November 24, 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 [ 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.
2. 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.
3. Percentage of participants reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ]
   As elicited by investigational site staff
4. 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
5. Percentage of subset participants with abnormal hematology and chemistry laboratory values [ Time Frame: 1 day after dose 1 ]
   As measured at the local laboratory
6. Percentage of subset participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 1 ]
   As measured at the local laboratory
7. Percentage of subset participants with abnormal hematology and chemistry laboratory values [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 month after dose 2 ]
    As measured at the central laboratory
12. 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
13. SARS-CoV-2 S1-binding IgG levels, expressed as GMCs [ Time Frame: 1 month after dose 2 ]
    as measured at the central laboratory
14. 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

Secondary Outcome Measures :

1. SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Through 1 year after dose 2 ]
   As measured at the central laboratory

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Japan

SOUSEIKAI Sumida Hospital

Sumida-ku, Tokyo, Japan, 130-0004

PS Clinic

Fukuoka, Japan, 812-0025

Sponsors and Collaborators

BioNTech SE

Pfizer

Investigators

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

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: BioNTech SE
• ClinicalTrials.gov Identifier: NCT04588480
• Other Study ID Numbers: C4591005
• First Posted: October 19, 2020
• Last Update Posted: August 18, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• 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/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• 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:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases