This is 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. After randomization, the trial for each subject will last for approximately 12 months. Screening period is 2 weeks prior to randomization (Day -14 to Day 0), and each dose of either SARS-CoV-2 vaccine (BNT162b1) or placebo will be given intramuscularly (IM).
Biological: BNT162b1
Intramuscular injection
Other: Placebo
Intramuscular injection
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.
Jiangsu Provincial Center for Disease Control and Prevention
Jiangsu, China
BioNTech Responsible Person, Study Director
BioNTech SE