Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
1:BNT162b2
2:placebo
Sponsors
Jiangsu Provincial Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female participants between the ages of 18 and 85 years, inclusive, at randomization; 2. Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures; 3. 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; 4. Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol; 5. SARS-CoV-2 antibody test screening is negative; 6. Negative SARS-CoV-2 test in throat swabs by RT-PCR (only for the first approximately 150 subjects); 7. Normal in chest CT scans (no imaging features of COVID-19, only for the first approximately 150 subjects).
Exclusion criteria
Exclusion criteria: 1. 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 investigators judgment, make the participant inappropriate for the study; 2. Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV); 3. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s); 4. Receipt of medications intended to prevent COVID-19; 5. Immunocompromised individuals with known or suspected immunodeficiency, determined by history and/or laboratory/physical examination; 6. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection; 7. Women who are pregnant or breastfeeding; 8. Previous vaccination with any coronavirus vaccine; 9. 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 (=37.3 degree C or oral temperature >= 38.0 degree C; 17. History of SARS, SARS-CoV-2 or MERS infection. Suspected SARS patients should be screened for SARS antibodies; 18. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion rates (SCR) of SARS-CoV-2 serum neutralizing titers;Geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing titers; | — |
Secondary
| Measure | Time frame |
|---|---|
| SCR of SARS-CoV-2 anti-S1 IgG antibody;GMT of SARS-CoV-2 anti-S1 IgG antibody;Geometric mean fold rise (GMFR) of SARS-CoV-2 serum neutralizing antibody titers;GMFR of SARS-CoV-2 anti-S1 IgG antibody;Local reactions;Systemic events;Abnormal hematology and chemistry laboratory values;Adverse events; | — |
Countries
China
Contacts
Public ContactZhu Fengcai
Jiangsu Provincial Center for Disease Prevention and Control
Outcome results
None listed