Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population

NCT04649021 | Completed Phase 2 DMC

• 1 other identifier: BNT162-06
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 1

Brief Summary

This was 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 lasted for approximately 13 months. Screening period was 2 weeks prior to randomization (Day -14 to Day 0), and two doses of either SARS-CoV-2 vaccine (BNT162b2) or placebo were given intramuscularly (IM) separated by 21 days.

Conditions

SARS-CoV-2

Keywords

Coronavirus Disease 2019; Coronavirus infection; Vaccine; Protection against COVID-19; Covid19; SARS (Severe Acute Respiratory Syndrome)

Outcome Measures

Primary Outcomes (2)

• SARS-CoV-2 serum neutralizing titers - Seroconversion rates (SCR)

  SCR of SARS-CoV-2 serum neutralizing titers at 1-month after dose 2. Seroconversion is defined as ≥4-fold rise from before vaccination to 1-month post dose 2.

  1 Month after Dose 2

• The geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing titers at 1 month after dose 2

  1 Month after Dose 2

Secondary Outcomes (14)

• SARS-CoV-2 serum neutralizing titers - SCR

  1 Week, 6 and 12 Months after Dose 2

• SARS-CoV-2 serum neutralizing titers - GMT

  1 Week, 6 and 12 Months after Dose 2

• SARS-CoV-2 anti-S1 immunoglobulin G (IgG) antibody level - SCR

  1 Week, 1, 6 and 12 Months after Dose 2

• SARS-CoV-2 anti-S1 IgG antibody level - GMT

  1 Week, 1, 6 and 12 Months after Dose 2

• SARS-CoV-2 serum neutralizing antibody level - Geometric mean fold rise (GMFR)

  1 Week, 1, 6 and 12 Months after Dose 2

Study Arms (2)

BNT162b2 18-85 years of age

EXPERIMENTAL

Biological: BNT162b2

Placebo 18-85 years of age

PLACEBO COMPARATOR

Other: Placebo

Interventions

BNT162b2 BIOLOGICAL

Intramuscular injection

BNT162b2 18-85 years of age

Placebo OTHER

Intramuscular injection

Placebo 18-85 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:

• Male or female participants between the ages of 18 and 85 years, inclusive, at randomization.
• Participants who were willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
• Capable of giving personal signed informed consent, which included compliance with the requirements and restrictions listed in the informed consent form and the protocol.
• SARS-CoV-2 antibody test screening was 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).

You may not qualify if:

• 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 were pregnant or breastfeeding.
• Previous vaccination with any coronavirus vaccine.
• Individuals who received 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 were 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.

Sponsors & Collaborators

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

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, 210009, China

Location

Related Publications (1)

• Hui AM, Li J, Zhu L, Tang R, Ye H, Lin M, Ge L, Wang X, Peng F, Wu Z, Guo X, Shi Y, Pan H, Zhu J, Song Z, Qiu J, Wang W, Zheng J, Ozhelvaci O, Shpyro S, Bushway M, Derhovanessian E, Kuhnle MC, Luxemburger U, Muik A, Shishkova Y, Khondker Z, Hu S, Lagkadinou E, Sahin U, Tureci O, Zhu F. Immunogenicity and safety of BNT162b2 mRNA vaccine in Chinese adults: A phase 2 randomised clinical trial. Lancet Reg Health West Pac. 2022 Dec;29:100586. doi: 10.1016/j.lanwpc.2022.100586. Epub 2022 Sep 14.

  PMID: 36120090 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; 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

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 2, 2020
• Study Start: December 4, 2020
• Primary Completion: February 7, 2021
• Study Completion: January 9, 2022
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)