SARS-CoV-2Phase 1NCT04523571

Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects

A Phase 1 study testing BNT162b1 in people with SARS-CoV-2, run by BioNTech SE at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: SARS-CoV-2
What is being tested?: BNT162b1
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 144 participants
Where: 1 siteChina
Study dates: 28 Jul 2020to 10 Aug 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Jiangsu Provincial Center for Disease Control and Prevention
Taizhou, Jiangsu, 210009

Other trials in China

About this study

Official title: Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects: A Phase I, Randomized, Placebo-controlled, Observer-blind Study

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.

Read the detailed description

The participants were screened for 2 weeks (Day -14 to Day 0) before randomization, and received 1 dose of SARS-CoV-2 vaccine (BNT162b1) or placebo intramuscularly (IM) on Day 1 and Day 22, respectively. After randomization, the study for each participant lasted for approximately 12 months.

Conditions: SARS-CoV-2
Being tested: BNT162b1, Placebo
Keywords: Protection against COVID-19, Coronavirus Disease 2019, Coronavirus infection, Vaccine, RNA Vaccine, Virus Diseases
Medical subject headings: COVID-19, Coronavirus Infections, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BNT162b1Biological
Intramuscular injection
PlaceboOther
Intramuscular injection

Study groups in NCT04523571
Study group	Role	What they receive
Low-dose, 18-55 years of age	Experimental	Not described Receives: Biological: BNT162b1
High-dose, 18-55 years of age	Experimental	Not described Receives: Biological: BNT162b1
Placebo, 18-55 years of age	Placebo comparator	Not described Receives: Other: Placebo
Low-dose, 65-85 years of age	Experimental	Not described Receives: Biological: BNT162b1
High-dose, 65-85 years of age	Experimental	Not described Receives: Biological: BNT162b1
Placebo, 65-85 years of age	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo.
Solicited local AEs were collected within 7 days/14 days after each vaccination. For the grading of AEs, a 7-day period AE assessment after each dose as graded by United States (US) Food and Drug Administration (FDA) criteria along with the 14-day period AE assessment as graded by National Medical Products Administration (NMPA) criteria are used to evaluate solicited AEs. For other AEs, only the NMPA criteria is used. The "solicited" AEs were pre-defined and listed in the subjects' diaries. All the solicited local AEs occurred within 7 days after vaccination were related to investigational vaccine (or placebo).
Measured: Up to 14 days following each dose administration
Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo.
Solicited systemic AEs were collected within 7 days/14 days after each vaccination. For the grading of AEs, a 7-day period AE assessment after each dose as graded by US FDA criteria along with the 14-day period AE assessment as graded by NMPA criteria are used to evaluate solicited AEs. For other AEs, only the NMPA criteria is used. The "solicited" AEs were pre-defined and listed in the subjects' diaries. Except for 1 event (myalgia) occurred in 10 µg group and 1 event (diarrhea) occurred in placebo group, all the solicited systemic AEs occurred within 7 days after vaccination were related to investigational vaccine (or placebo). All the solicited systemic AEs occurred within 14 days after vaccination were related to investigational vaccine (or placebo), except for 1 event (myalgia) occurred in placebo group and 2 events (both diarrhea; 1 event occurred in 30 µg group, 1 event occurred in placebo group).
Measured: Up to 14 days following each dose administration
Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo.
AEs occurred during the 21-day period after dose 1 were also referred as "unsolicited" AEs. The unsolicited AEs were not pre-defined in the subjects' diaries.
Measured: 21-day period after dose 1 vaccination
Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo.
AEs occurred during the 28-day period after dose 2 were also referred as "unsolicited" AEs. The unsolicited AEs were not pre-defined in the subjects' diaries.
Measured: 28-day period after dose 2 vaccination

Secondary outcomes (10)

The Number of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs)
Measured: From Dose 1 up to Month 12
The Number of Participants Experiencing Related TEAEs
"Related" implies the relationship between AE and vaccine is one of "Possibly related", "Probably related" and "Definitely related".
Measured: From Dose 1 up to Month 12
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis
Results for CS results are displayed by abnormal parameter. Abnormal test results assessed not clinical significant are not presented. Participants with more than one 'CS' parameter are counted for each parameter separately and therefore included multiple times.
Measured: Hour 24 and Day 7 after dose 1 and Day 7 after dose 2
Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody
At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6 and 12 after dose 1.
Measured: Up to 12 months following first dose
GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody
At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6 and 12 after dose 1.
Measured: Up to 12 months following first dose
GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test)
At Day 7, Day 21 after first dose, at Day 7, Day 21 after second dose, and at Month 3, 6, and 12 after first dose.
Measured: Up to 12 months following first dose
Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline
At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6, and 12 after dose 1.
Measured: Up to 12 months following the first dose
Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline
At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6, and 12 after dose 1.
Measured: Up to 12 months following first dose
Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline.
At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6, and 12 after dose 1.
Measured: Up to 12 months following first dose
Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline
At Day 7, Day 21 after dose 1, and at Day 7, Day 21 after dose 2.
Measured: Up to 21 days after dose 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 202010 Aug 2021

First posted21 Aug 2020
Study start28 Jul 2020
Primary completion30 Sep 2020
Study completion10 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SARS-CoV-2Studies of the same condition, open and under way.
More trials run by BioNTech SEThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04523571
Sponsor's protocol ID: BNT162-03
Status last verified: Sep 2023
First submitted: 18 Aug 2020
Last updated: 18 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Li J, Hui AM, Zhang X, Ge L, Qiu Y, Tang R, Ye H, Wang X, Lin M, Zhu Z, Zheng J, Qiu J, Lagkadinou E, Shpyro S, Ozhelvaci O, Tureci O, Khondker Z, Yin W, Shishkova Y, Jia S, Pan H, Peng F, Ma Z, Wu Z, Guo X, Shi Y, Muik A, Sahin U, Zhu L, Zhu F. Immune Persistence and Safety After SARS-CoV-2 BNT162b1 mRNA Vaccination in Chinese Adults: A Randomized, Placebo-Controlled, Double-Blind Phase 1 Trial. Adv Ther. 2022 Aug;39(8):3789-3798. doi: 10.1007/s12325-022-02206-1. Epub 2022 Jun 30.
PubMed 35771353

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects: A Phase I, Randomized, Placebo-controlled, Observer-blind Study
ClinicalTrials.gov ID: NCT04523571
Acronym / sponsor ID: BNT162-03
Conditions: SARS-CoV-2
Keywords: Protection against COVID-19, Coronavirus Disease 2019, Coronavirus infection, Vaccine, RNA Vaccine, Virus Diseases
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: BioNTech SEIndustry (pharma, biotech, devices)
Collaborators: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Study start: 28 Jul 2020 (actual)
Primary completion: 30 Sep 2020 (actual)
Study completion: 10 Aug 2021 (actual)
First posted: 21 Aug 2020 (actual)
Results: Posted 18 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Low-dose, 18-55 years of age	Experimental	Biological: BNT162b1
High-dose, 18-55 years of age	Experimental	Biological: BNT162b1
Placebo, 18-55 years of age	Placebo comparator	Other: Placebo
Low-dose, 65-85 years of age	Experimental	Biological: BNT162b1
High-dose, 65-85 years of age	Experimental	Biological: BNT162b1
Placebo, 65-85 years of age	Placebo comparator	Other: Placebo

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (30 listed)

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.

Key exclusion criteria (58 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BNT162b1Intramuscular injection	Biological	High-dose, 18-55 years of age, High-dose, 65-85 years of age, Low-dose, 18-55 years of age, Low-dose, 65-85 years of age
PlaceboIntramuscular injection	Other	Placebo, 18-55 years of age, Placebo, 65-85 years of age

Primary outcome

Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo.
Time frame: Up to 14 days following each dose administration
Solicited local AEs were collected within 7 days/14 days after each vaccination. For the grading of AEs, a 7-day period AE assessment after each dose as graded by United States (US) Food and Drug Administration (FDA) criteria along with the 14-day period AE assessment as graded by National Medical Products Administration (NMPA) criteria are used to evaluate solicited AEs. For other AEs, only the NMPA criteria is used. The "solicited" AEs were pre-defined and listed in the subjects' diaries. All the solicited local AEs occurred within 7 days after vaccination were related to investigational vaccine (or placebo).
Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo.
Time frame: Up to 14 days following each dose administration
Solicited systemic AEs were collected within 7 days/14 days after each vaccination. For the grading of AEs, a 7-day period AE assessment after each dose as graded by US FDA criteria along with the 14-day period AE assessment as graded by NMPA criteria are used to evaluate solicited AEs. For other AEs, only the NMPA criteria is used. The "solicited" AEs were pre-defined and listed in the subjects' diaries. Except for 1 event (myalgia) occurred in 10 µg group and 1 event (diarrhea) occurred in placebo group, all the solicited systemic AEs occurred within 7 days after vaccination were related to investigational vaccine (or placebo). All the solicited systemic AEs occurred within 14 days after vaccination were related to investigational vaccine (or placebo), except for 1 event (myalgia) occurred in placebo group and 2 events (both diarrhea; 1 event occurred in 30 µg group, 1 event occurred in placebo group).
Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo.
Time frame: 21-day period after dose 1 vaccination
AEs occurred during the 21-day period after dose 1 were also referred as "unsolicited" AEs. The unsolicited AEs were not pre-defined in the subjects' diaries.
Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo.
Time frame: 28-day period after dose 2 vaccination
AEs occurred during the 28-day period after dose 2 were also referred as "unsolicited" AEs. The unsolicited AEs were not pre-defined in the subjects' diaries.

10 secondary outcomes

The Number of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: From Dose 1 up to Month 12
The Number of Participants Experiencing Related TEAEs
Time frame: From Dose 1 up to Month 12
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis
Time frame: Hour 24 and Day 7 after dose 1 and Day 7 after dose 2
Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody
Time frame: Up to 12 months following first dose
GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody
Time frame: Up to 12 months following first dose
GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test)
Time frame: Up to 12 months following first dose
Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline
Time frame: Up to 12 months following the first dose
Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline
Time frame: Up to 12 months following first dose
Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline.
Time frame: Up to 12 months following first dose
Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline
Time frame: Up to 21 days after dose 2

Results and safety

Results posted to the registry on 18 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low-dose 10 µg, 18-55 Years of Age	24	24
High-dose 30 µg, 18-55 Years of Age	24	24
Placebo, 18-55 Years of Age	24	24
Low-dose 10 µg, 65-85 Years of Age	24	23
High-dose 30 µg, 65-85 Years of Age	24	23
Placebo, 65-85 Years of Age	24	24

Primary outcome: Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo.

Time frame: Up to 14 days following each dose administration. Count of participants. Unit: Participants

Measure	Low-dose 10 µg, 18-55 Years of Age n = 24	High-dose 30 µg, 18-55 Years of Age n = 24	Placebo, 18-55 Years of Age n = 24	Low-dose 10 µg, 65-85 Years of Age n = 24	High-dose 30 µg, 65-85 Years of Age n = 24
Within 7 days after dose 1: Number of participants with solicited local AEs	19	24	1	13	19
Within 7 days after dose 2: Number of participants with solicited local AEs	17	20	1	15	15
Within 7 days after dose 1: Number of participants with solicited local AEs grade 3 (FDA criteria)	0	0	0	0	0
Within 7 days after dose 2: Number of participants with solicited local AEs grade 3 (FDA criteria)	0	0	0	0	0
Within 14 days after dose 1: Number of participants with solicited local AEs grade 3 (NMPA criteria)	0	0	0	0	0
Within 14 days after dose 2: Number of participants with solicited local AEs grade 3 (NMPA criteria)	0	0	0	0	0

Population analysed: Safety Analysis Set including all randomized participants who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.

Primary outcome: Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo.

Time frame: Up to 14 days following each dose administration. Count of participants. Unit: Participants

Measure	Low-dose 10 µg, 18-55 Years of Age n = 24	High-dose 30 µg, 18-55 Years of Age n = 24	Placebo, 18-55 Years of Age n = 24	Low-dose 10 µg, 65-85 Years of Age n = 24	High-dose 30 µg, 65-85 Years of Age n = 24	Placebo, 65-85 Years of Age n = 24
Within 7 d (days) after dose 1: Number of participants with solicited systemic AEs	9	16	3	3	15	2
Within 7 d after dose 2: Number of participants with solicited systemic AEs	15	21	3	7	17	1
Within 14 d after dose 1: Number of participants with solicited systemic AEs	10	16	3	3	15	2
Within 14 d after dose 2: Number of participants with solicited systemic AEs	15	21	3	7	17	2
Within 7 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (FDA)	0	1	0	0	2	0
Within 7 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (FDA)	1	3	0	0	0	0
Within 14 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (NMPA)	0	5	0	0	2	0
Within 14 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (NMPA)	3	6	0	0	0	0

Population analysed: Safety Analysis Set including all randomized participants who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.

Primary outcome: Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo.

Time frame: 21-day period after dose 1 vaccination. Number. Unit: participants

Measure	Low-dose 10 µg, 18-55 Years of Age n = 24	High-dose 30 µg, 18-55 Years of Age n = 24	Placebo, 18-55 Years of Age n = 24	Low-dose 10 µg, 65-85 Years of Age n = 24	High-dose 30 µg, 65-85 Years of Age n = 24	Placebo, 65-85 Years of Age n = 24
Value	7	7	1	2	5	2

Population analysed: Safety Analysis Set including all randomized participants who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.

Primary outcome: Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo.

Time frame: 28-day period after dose 2 vaccination. Number. Unit: participants

Measure	Low-dose 10 µg, 18-55 Years of Age n = 24	High-dose 30 µg, 18-55 Years of Age n = 24	Placebo, 18-55 Years of Age n = 24	Low-dose 10 µg, 65-85 Years of Age n = 24	High-dose 30 µg, 65-85 Years of Age n = 24	Placebo, 65-85 Years of Age n = 24
Value	5	8	0	2	7	0

Population analysed: Safety Analysis Set including all randomized participants who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 (Dose 1) up to last visit (approximately 12 months after first dose). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low-dose 10 µg, 18-55 Years of Age	0 of 24 (0%)	22 of 24 (91.7%)	0 of 24
High-dose 30 µg, 18-55 Years of Age	1 of 24 (4.2%)	24 of 24 (100%)	0 of 24
Placebo, 18-55 Years of Age	1 of 24 (4.2%)	7 of 24 (29.2%)	0 of 24
Low-dose 10 µg, 65-85 Years of Age	1 of 24 (4.2%)	22 of 24 (91.7%)	0 of 24
High-dose 30 µg, 65-85 Years of Age	0 of 24 (0%)	24 of 24 (100%)	0 of 24
Placebo, 65-85 Years of Age	0 of 24 (0%)	9 of 24 (37.5%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35771353Li J, Hui AM, Zhang X, Ge L, Qiu Y, Tang R, Ye H, Wang X, Lin M, Zhu Z, Zheng J, Qiu J, Lagkadinou E, Shpyro S, Ozhelvaci O, Tureci O, Khondker Z, Yin W, Shishkova Y, Jia S, Pan H, Peng F, Ma Z, Wu Z, Guo X, Shi Y, Muik A, Sahin U, Zhu L, Zhu F. Immune Persistence and Safety After SARS-CoV-2 BNT162b1 mRNA Vaccination in Chinese Adults: A Randomized, Placebo-Controlled, Double-Blind Phase 1 Trial. Adv Ther. 2022 Aug;39(8):3789-3798. doi: 10.1007/s12325-022-02206-1. Epub 2022 Jun 30.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

BioNTech Responsible Person study director

BioNTech SE

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BNT162b1 in people with SARS-CoV-2, run by BioNTech SE at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 58 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. (time frame: Up to 14 days following each dose administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04523571, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.