Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population: A Phase II, Randomized, Placebo-controlled, Observer-blinded Study

BioNTech SE1 个研究点分布在 1 个国家目标入组 960 人2020年12月4日

适应症SARS-CoV-2

概览

阶段: 2 期
干预措施: 未指定
疾病 / 适应症: SARS-CoV-2
发起方: BioNTech SE
入组人数: 960
试验地点: 1
主要终点: SARS-CoV-2 serum neutralizing titers - Seroconversion rates (SCR)
状态: 已完成
最后更新: 上个月

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2020年12月4日

结束日期

2022年1月9日

最后更新

上个月

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

BioNTech SE

责任方

Sponsor

入排标准

入选标准

•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.
•Healthy participants who were determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, were allowed to be included.
•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).

排除标准

•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-
•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.

结局指标

主要结局

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

时间窗: 1 Month after Dose 2

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.

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

时间窗: 1 Month after Dose 2

次要结局

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)
SARS-CoV-2 anti-S1 IgG antibody level - GMFR(1 Week, 1, 6 and 12 Months after Dose 2)
Percentage of participants reporting local reactions(Within 7 Days and 14 Days after each vaccination)
Percentage of participants reporting systemic events(Within 7 Days and 14 Days after each vaccination)
Hematology laboratory assessments(Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2)
Chemistry laboratory assessments(Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2)
Adverse events (AEs)(From Dose 1 through 1 Month after the last Dose)
Serious AEs (SAEs)(From Dose 1 through 6 Months after the last Dose)
Hematology laboratory assessments(Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2)
Chemistry laboratory assessments(Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2)