Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects
Condition: SARS-CoV-2
Intervention: BNT162b1; Placebo
Intervention description: Intramuscular injection; Intramuscular injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Protection against COVID-19; Coronavirus Disease 2019; Coronavirus infection; Vaccine; RNA Vaccine; Virus Diseases

Summary:

      This was a phase I, randomized, placebo-controlled, observer-blind study, for evaluation of
      safety and immunogenicity of SARS-CoV-2 mRNA vaccine (BNT162b1) in Chinese healthy
      population.
    

Eligibility criteria:

        Inclusion Criteria:

        For adult group (age ≥18 and ≤55)

          -  Male or female subjects of ≥18 years old and ≤55 years old with body mass index (BMI)
             ≥18 and ≤30 at the Screening Visit.

          -  Individuals who are in good health condition at the time of entry into the trial as
             determined by medical history, physical examination (including vital signs,
             electrocardiogram [ECG]) and eligibility screening test (hematology, blood chemistry
             and urine analysis) and clinical judgment of the investigator at Screening Visit.

          -  The subject can provide with informed consent and signs and dates a written informed
             consent form (ICF) prior to the initiation of any trial procedures.

          -  They must be able to understand and follow trial-related instructions.

          -  They must be willing and able to comply with planned visits, treatment schedule,
             laboratory tests and other requirements of the trial.

          -  Negative in antibodies screening of SARS-CoV-2 (fingerstick).

          -  Normal in chest computed tomography (CT) scans (no imaging features of COVID-19).

          -  Axillary temperature ≤ 37.0ºC.

          -  Negative SARS-CoV-2 test in throat swabs by reverse transcription-polymerase chain
             reaction (RT-PCR).

          -  Women of childbearing potential (WOCBP) must have a negative beta-human chorionic
             gonadotropin (β-hCG) in serum sample at Screening Visit. Women that are postmenopausal
             (Menopause≥12 consecutive months) or permanently sterilized will be considered as not
             having reproductive potential.

          -  WOCBP must have used effective contraception 14 days prior to screening and agree to
             use effective contraception continuously during the trial period, from 14 days prior
             to Screening Visit to 60 days after the last immunization.

          -  WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted
             reproduction during trial, starting from Screening Visit and continuously until 60
             days after being given the last immunization.

          -  Men who are sexually active with a WOCBP and have not had a vasectomy must agree to
             practice an effective form of contraception with their female partner of childbearing
             potential during the trial, starting from Screening Visit and continuously until 60
             days after being given the last immunization.

          -  Men must be willing to refrain from sperm donation, starting from Screening Visit and
             continuously until 60 days after receiving the last immunization.

        For the elderly group (age ≥65 and ≤85)

          -  Male or female subjects ≥65 years old and ≤85 years old at Screening Visit

          -  Individuals who are in a health condition that can receive the investigational
             vaccine, at the time of entry into the trial as determined by medical history,
             physical examination (including vital signs, ECG) and eligibility screening tests
             (hematology, biochemistry and urinalysis) and clinical judgment of the investigator at
             Screening Visit.

          -  The subject can provide with informed consent and signs and dates a written ICF prior
             to the initiation of any trial procedures.

          -  They must be able to understand and follow trial-related instructions.

          -  They must be willing and able to comply with planned visits, treatment schedule,
             laboratory tests and other requirements of the trial.

          -  Negative in antibodies screening of SARS-CoV-2 (blood sample from fingertip).

          -  No imaging features of COVID-19 in chest CT.

          -  Axillary temperature ≤ 37.0ºC.

          -  Negative SARS-CoV-2 test in throat swabs by RT-PCR.

          -  WOCBP must have a negative serum β-hCG at Screening Visit. Women that are
             postmenopausal (Menopause ≥12 consecutive months) or permanently sterilized will be
             considered as not having reproductive potential.

          -  WOCBP must have used effective contraception 14 days prior to screening and agree to
             use effective contraception continuously during the trial period, from 14 days prior
             to Screening Visit to 60 days after the last immunization.

          -  WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted
             reproduction during trial, starting from Screening Visit and continuously until 60
             days after being given the last immunization.

          -  Men who are sexually active with a WOCBP and have not had a vasectomy must agree to
             practice an effective form of contraception with their female partner of childbearing
             potential during the trial, starting from Screening Visit and continuously until 60
             days after being given the last immunization.

          -  Men must be willing to refrain from sperm donation, starting from Screening Visit and
             continuously until 60 days after receiving the last immunization.

        Exclusion Criteria:

        For adult group (age ≥18 and ≤55)

          -  Have had any acute illness, as determined by the investigator, with or without fever,
             within 72 hours prior to the prime vaccination. An acute illness which is nearly
             resolved with only minor residual symptoms remaining is allowable if, in the opinion
             of the investigator, the residual symptoms will not compromise their well-being if
             they participate as trial subjects in the trial, or that could prevent, limit, or
             confound the protocol-specified assessments.

          -  Are breastfeeding on the day of Screening Visit or who plan to breastfeed during the
             trial, starting from Screening Visit and continuously until at least 90 days after the
             last immunization. Women or partners who plan to become pregnant within 1 year post
             the Screening Visit.

          -  Have a known allergy, hypersensitivity, or intolerance to the planned vaccine for
             trial including any excipients.

          -  Used to have a history of hypersensitivity or serious reactions to vaccination.

          -  Received any vaccination within 4 weeks prior to Visit 1.

          -  Don't agree to not be vaccinated during the trial, starting from Screening Visit and
             continuously until 28 days after receiving the last immunization, except emergency
             vaccination (e.g. rabies vaccine, tetanus vaccine).

          -  Had any medical condition (e.g., autoimmune disease) or any major surgery (e.g.,
             requiring general anesthesia) within the past 5 years, which in the opinion of the
             investigator, could compromise their well-being if they participate as trial subjects
             in the trial, or that could prevent, limit, or confound the protocol-specified
             assessments.

          -  Have any surgery planned during the trial, starting from Screening Visit and
             continuously until at least 90 days after the last immunization.

          -  Had any chronic use (more than 14 continuous days) of any systemic medications that
             affects immune function, including immunosuppressant or other immune-modifying drugs,
             within 6 months prior to Screening Visit unless in the opinion of the investigator,
             the medication would not prevent, limit, or confound the protocol-specified
             assessments or could compromise safety of subjects.

          -  Had administration of any immunoglobulins and/or any blood products within the 3
             months prior to Screening Visit.

          -  Had administration of another investigational product including vaccines within 60
             days or 5 half-lives (whichever is longer), prior to Screening Visit.

          -  With known history of AIDS or human immunodeficiency virus (HIV) test positive.

          -  History of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, through
             medical inquiry.

          -  History of SARS, SARS-CoV-2 or middle east respiratory syndrome (MERS) infection.
             Suspected SARS patients should be screened for SARS antibodies.

          -  Previously participated in a clinical trial involving lipid nanoparticles.

          -  Are subject to exclusion periods of other clinical trials or simultaneous
             participation in another clinical trial.

          -  Have any affiliation with the study site (e.g., are close relative of the investigator
             or dependent person, such as an employee or student of the study site).

          -  Have a history of drug abuse or known medical, psychological, or social conditions
             within the past 5 years. In the opinion of the investigator, could comprise their
             well-being if they participate as trial subjects in the trial, or that could prevent,
             limit, or confound the protocol-specified assessments.

          -  Have a history of narcolepsy.

          -  Have history of alcohol abuse or drug addiction within 1 year prior to Screening
             Visit.

          -  Have a history of or suspected immunosuppressive condition, acquired or congenital, as
             determined by medical history and/or physical examination at Screening Visit.

          -  Have any abnormality or permanent body art (e.g., tattoo), that in the opinion of the
             investigator, would obstruct the ability to observe local reactions at the vaccination
             site.

          -  Have had any blood loss >400 mL, e.g., due to donation of blood or blood products or
             injury, within the 28 days prior to Screening Visit or plan to donate blood or plasma
             during the trial, starting from Screening Visit and continuously until at least 28
             days after being given the last immunization.

          -  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.

          -  They plan to visit any country or region with a high SARS-CoV-2 infection risk (as
             defined at Screening Visit), from Screening Visit until 14 days after being given the
             last immunization.

          -  Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath
             and breathing difficulties.

          -  Have had contact with confirmed COVID-19 patients or persons tested positive for
             SARS-CoV-2 within the 30 days prior to Screening Visit.

          -  Are vulnerable persons, e.g., soldiers, subjects in detention, contract research
             organization (CRO) or Fosun staff or their family members.

        For the elderly group (age ≥65 and ≤85)

          -  Baseline laboratory abnormalities with Grade ≥3 (for hematology abnormalities with
             Grade ≥2) during screening visits, by physical examination and eligibility screening.

          -  Have had any acute illness, as determined by the investigator, with or without fever,
             within 72 hours prior to the prime vaccination. An acute illness which is nearly
             resolved with only minor residual symptoms remaining is allowable if, in the opinion
             of the investigator, the residual symptoms will not compromise their well-being if
             they participate as trial subjects in the trial, or that will not prevent, limit, or
             confound the protocol-specified assessments.

          -  Have a known allergy, hypersensitivity, or intolerance to the planned vaccine for
             trial including any excipients.

          -  Used to have a history of hypersensitivity or serious reactions to vaccination.

          -  Received any vaccination within 4 weeks prior to Visit 1.

          -  Don't agree to not be vaccinated during the trial, starting from Screening Visit and
             continuously until 28 days after receiving the last immunization, except emergency
             vaccination (e.g. rabies vaccine, tetanus vaccine).

          -  Had administration of any immunoglobulins and/or any blood products within the 3
             months prior to Screening Visit.

          -  Had any serious or life-threatening medical condition (e.g., autoimmune disease,
             cardiovascular disease) within the past 5 years, which in the opinion of the
             investigator, could compromise their well-being if they participate as trial subjects
             in the trial, or that could prevent, limit, or confound the protocol-specified
             assessments.

          -  Have any surgery planned during the trial, starting from Screening Visit and
             continuously until at least 90 days after the last immunization.

          -  Had any chronic use (more than 14 continuous days) of any systemic medications that
             affects immune function, including immunosuppressant or other immune-modifying drugs,
             within 6 months prior to Screening Visit unless in the opinion of the investigator,
             the medication would not prevent, limit, or confound the protocol-specified
             assessments or could compromise safety of subjects.

          -  Had administration of another investigational product including vaccines within 60
             days or 5 half-lives (whichever is longer), prior to Screening Visit.

          -  With known history of AIDS or HIV test positive.

          -  History of HBV or HCV infection.

          -  History of SARS, SARS-CoV-2 or MERS infection. Suspected SARS patients should be
             screened for SARS antibodies.

          -  Previously participated in a clinical trial involving lipid nanoparticles.

          -  Are subject to exclusion periods of other clinical trials or simultaneous
             participation in another clinical trial.

          -  Have any affiliation with the study site (e.g., are close relative of the investigator
             or dependent person, such as an employee or student of the study site).

          -  Have a history of drug abuse or known medical, psychological, or social conditions
             within the past 5 years. In the opinion of the investigator, could comprise their
             well-being if they participate as trial subjects in the trial, or that could prevent,
             limit, or confound the protocol-specified assessments.

          -  Have a history of narcolepsy.

          -  Have history of alcohol abuse or drug addiction within 1 year prior to Screening
             Visit.

          -  Have a history of or suspected immunosuppressive condition, acquired or congenital, as
             determined by medical history and/or physical examination at Screening Visit.

          -  Have any abnormality or permanent body art (e.g., tattoo), that in the opinion of the
             investigator, would obstruct the ability to observe local reactions at the vaccination
             site.

          -  Have had any blood loss >400 mL, e.g., due to donation of blood or blood products or
             injury, within the 28 days prior to Screening Visit or plan to donate blood or plasma
             during the trial, starting from Screening Visit and continuously until at least 28
             days after being given the last immunization.

          -  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.

          -  They plan to visit any country or region with a high SARS-CoV-2 infection risk (as
             defined at Screening Visit), from Screening Visit until 14 days after being given the
             last immunization.

          -  Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath
             and breathing difficulties.

          -  Have had contact with confirmed COVID-19 patients or persons tested positive for
             SARS-CoV-2 nucleic acids or antibodies within the 30 days prior to Screening Visit.

          -  Are vulnerable persons, e.g., soldiers, subjects in detention, CRO or Fosun staff or
             their family members.