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

NCT04523571 | Completed Phase 1 Results DMC

• 1 other identifier: BNT162-03
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS-CoV-2

Keywords

Protection against COVID-19; Coronavirus Disease 2019; Coronavirus infection; Vaccine; RNA Vaccine; Virus Diseases

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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.

  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.

  28-day period after dose 2 vaccination

Secondary Outcomes (10)

• The Number of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs)

  From Dose 1 up to Month 12

• The Number of Participants Experiencing Related TEAEs

  From Dose 1 up to Month 12

• The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis

  Hour 24 and Day 7 after dose 1 and Day 7 after dose 2

• Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody

  Up to 12 months following first dose

• GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody

  Up to 12 months following first dose

Study Arms (6)

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

Interventions

BNT162b1 BIOLOGICAL

Intramuscular injection

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

Placebo OTHER

Intramuscular injection

Placebo, 18-55 years of age; Placebo, 65-85 years of age

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioNTech SE: lead
• Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.: collaborator

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention

Taizhou, Jiangsu, 210009, China

Location

Related Publications (1)

• 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.

  PMID: 35771353 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Virus Diseases

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: BioNTech clinical trials patient information
• Organization: BioNTech SE

patients@biontech.de

+49 6131 9084

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: July 28, 2020
• Primary Completion: September 30, 2020
• Study Completion: August 10, 2021
• Last Updated: September 18, 2023
• Results First Posted: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)