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

JRCT ID: jRCT2071200045

Registered date:20/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 21/10/2020
• Target sample size: 160
• Study type: Interventional
• Intervention(s): BNT162b2 (intramuscular injection), Placebo (intramuscular injection)

Outcome(s)

Primary Outcome

* Local reactions (Pain at the injection site, redness, and swelling as self-reported on electronic diaries.) for 7 days after dose 1 and dose 2
* Systemic events (Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.) for 7 days after dose 1 and dose 2
* AEs from Dose 1 to 1 month after the last dose
* SAEs from Dose 1 to 12 months after the last dose
* SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs at 1 month after dose 2
* GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to 1 month after Dose 2
* SARS-CoV-2 S1-binding IgG levels, expressed as GMCs at 1 month after Dose 2
* GMFR in SARS-CoV-2 S1-binding IgG levels from before vaccination to 1 month after Dose
In addition, in a subset participants, the percentage of participants with:
* Abnormal hematology and chemistry laboratory values 1 and 7 days after Dose 1; and 7 days after Dose 2
* Grading shifts in hematology and chemistry laboratory assessments between baseline and 1 and 7 days after Dose 1; and before Dose 2 and 7 days after Dose 2

Secondary Outcome

* SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs, through 1 year after dose 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
* SARS-CoV-2 S1-binding IgG levels, expressed as GMCs, through 1 year after dose 2
* 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
* 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include 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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary Sponsor: Pfizer
• Secondary ID(s): NCT04588480