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.
Biological: BNT162b2
Intramuscular injection
Other: Placebo
Intramuscular injection
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.
Jiangsu Provincial Center for Disease Control and Prevention
Jiangsu, China
BioNTech Responsible Person, Study Director
BioNTech SE