Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population

Study Overview
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Brief Summary
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This is a phase II, randomized, placebo-controlled, observer-blinded study of the safety and immunogenicity of SARS-CoV-2 messenger RNA (mRNA) vaccine (BNT162b2) in Chinese healthy population. After randomization, the trial for each participant will last for approximately 13 months. Screening period is 2 weeks prior to randomization (Day -14 to Day 0), and two doses of either SARS-CoV-2 vaccine (BNT162b2) or placebo will be given intramuscularly (IM) separated by 21 days.

Official Title
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Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population: A Phase II, Randomized, Placebo-controlled, Observer-blinded Study

Conditions
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SARS-CoV-2

Intervention / Treatment
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* Biological: BNT162b2
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female participants between the ages of 18 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 (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol. SARS-CoV-2 antibody test screening is negative. Negative SARS-CoV-2 test in throat swabs by reverse transcription-polymerase chain reaction (RT-PCR) (only for the first approximately 150 subjects). Normal in chest computed tomography (CT) scans (no imaging features of coronavirus disease 2019 (COVID-19), only for the first approximately 150 subjects). 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. Immunocompromised individuals with known or suspected immunodeficiency, 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. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. 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. Have had contact with confirmed COVID-19 patients or persons tested positive for SARS-CoV-2 within the 30 days prior to Screening Visit. Travel or live in any country or region with a high SARS-CoV-2 infection risk (as defined at Screening Visit) within the 14 days prior to Screening Visit. Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. Fever, defined as axillary temperature ≥37.3ºC or oral temperature ≥38ºC. History of SARS, SARS-CoV-2 or middle east respiratory syndrome (MERS) infection. Suspected SARS patients should be screened for SARS antibodies. Investigator site staff or Fosun employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BNT162b2 18-85 years of age<br> | Biological: BNT162b2<br>* Intramuscular injection<br>|
| Placebo Comparator: Placebo 18-85 years of age<br> | Other: Placebo<br>* Intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 serum neutralizing titers - Seroconversion rates (SCR) | SCR of SARS-CoV-2 serum neutralizing titers at 1-month after dose 2. Seroconversion is defined as ≥4-fold rise from before vaccination to 1-month post dose 2. | 1 Month after Dose 2 | 
| The geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing titers at 1 month after dose 2 |  | 1 Month after Dose 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 serum neutralizing titers - SCR | Compared with baseline before Vaccination 1, SCR of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2. | 1 Week, 6 and 12 Months after Dose 2 | 
| SARS-CoV-2 serum neutralizing titers - GMT | GMT of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2. | 1 Week, 6 and 12 Months after Dose 2 | 
| SARS-CoV-2 anti-S1 immunoglobulin G (IgG) antibody level - SCR | Compared with baseline before Vaccination 1, SCR of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2. | 1 Week, 1, 6 and 12 Months after Dose 2 | 
| SARS-CoV-2 anti-S1 IgG antibody level - GMT | GMT of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2. | 1 Week, 1, 6 and 12 Months after Dose 2 | 
| SARS-CoV-2 serum neutralizing antibody level - Geometric mean fold rise (GMFR) | Compared with baseline before Vaccination 1, the GMFR of SARS-CoV-2 serum neutralizing antibody titers at 1 week, 1, 6 and 12 months after dose 2. | 1 Week, 1, 6 and 12 Months after Dose 2 | 
| SARS-CoV-2 anti-S1 IgG antibody level - GMFR | Compared with baseline before Vaccination 1, GMFR of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2. | 1 Week, 1, 6 and 12 Months after Dose 2 | 
| Percentage of participants reporting local reactions | Pain at the injection site, redness, and swelling as self-reported on diary cards. | Within 7 Days and 14 Days after each vaccination | 
| Percentage of participants reporting systemic events | Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on diary cards. | Within 7 Days and 14 Days after each vaccination | 
| Hematology laboratory assessments | Percentage of participants with abnormal hematology laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2. | Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2 | 
| Chemistry laboratory assessments | Percentage of participants with abnormal chemistry laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2. | Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2 | 
| Hematology laboratory assessments | Percentage of participants with grading shifts in hematology laboratory assessments between baseline and 1 and 7 days after dose 1; and before dose 2 and 7 days after dose 2. | Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2 | 
| Chemistry laboratory assessments | Percentage of participants with grading shifts in chemistry laboratory assessments between baseline and 1 and 7 days after dose 1; and before dose 2 and 7 days after dose 2. | Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2 | 
| Adverse events (AEs) | AEs from dose 1 to 1 month after the last dose. | From Dose 1 through 1 Month after the last Dose | 
| Serious AEs (SAEs) | SAEs from dose 1 to 6 months after the last dose. | From Dose 1 through 6 Months after the last Dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus Disease 2019, Coronavirus infection, Vaccine, Protection against COVID-19, Covid19, SARS (Severe Acute Respiratory Syndrome)