Immunogenicity and Safety of a Single Dose of mRNA COVID-19 Vaccine in Chinese Adults With Hybrid Immunity: a Multicentre, Open-label, Single-arm, Post-marketing Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,052
- 试验地点
- 1
- 主要终点
- Geometric mean titer (GMT) of neutralizing antibodies in the immunogenicity subgroup
研究概览
简要总结
This is a multicentre post-marketing cohort study to evaluate the immunogenicity and safety of a single dose of mRNA SARS-CoV-2 vaccine SYS6006 in Chinese adults predominantly with hybrid immunity. A total of 2,052 adults aged 18 years and older who received one dose of SYS6006 were monitored for serious adverse events (SAEs) for 6 months. The first 60 participants comprised an immunogenicity subgroup, with blood samples collected before vaccination and at day 14, month 3, and month 6 post-vaccination to assess humoral and cellular immune responses.
详细描述
This study evaluated the immunogenicity and safety of a single dose of the mRNA SARS-CoV-2 vaccine SYS6006 (CSPC Megalith Biopharmaceutical Co., Ltd, Shijiazhuang, China) in Chinese adults aged 18 years and older predominantly with hybrid immunity against COVID-19. Between May and August 2023, 2,052 adults in five cities of Jiangsu Province, China (Taizhou, Changzhou, Lianyungang, Suqian, and Wuxi) received one intramuscular dose of SYS6006 (30 μg mRNA/0.3 mL) and were followed for 6 months to monitor serious adverse events (SAEs). The first 60 participants comprised the immunogenicity subgroup; serum and peripheral blood mononuclear cells (PBMCs) were collected before vaccination and at day 14, month 3, and month 6 post-vaccination. Immunogenicity assessments included pseudovirus neutralizing antibody geometric mean titres (GMTs) against wild-type (WT), BA.4/5, and XBB.1.16; receptor-binding domain (RBD)-specific IgG and IgA; ACE2-RBD binding inhibition; Fc-mediated effector functions (ADCP, ADCC, ADNP); and IFN-γ/IL-2 ELISpot responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years and over, including the elderly over 60 years and those with general underlying diseases.
- •At least 4 months since the last SARS-CoV-2 infection (or never infected), and at least 6 months since the last COVID-19 vaccination.
- •Able and willing to comply with the study procedures and to provide written informed consent.
排除标准
- •Suspected COVID-19 symptoms on the day of enrollment (e.g., dry/sore throat, cough).
- •Positive SARS-CoV-2 antigen rapid test at enrollment.
- •Prior receipt of the first COVID-19 booster dose .
- •History of severe adverse reactions or anaphylaxis related to vaccination, or known severe allergy to any vaccine component.
- •Pregnant or lactating women.
- •Any other condition that, in the investigator's judgment, makes the individual unsuitable for the study.
研究组 & 干预措施
SYS6006 single-dose recipients
Participants in this arm received a single intramuscular dose of SYS6006 (CSPC Megalith Biopharmaceutical Co., Ltd, Shijiazhuang, China), a lipid nanoparticle (LNP)-encapsulated mRNA SARS-CoV-2 vaccine containing 30 μg mRNA in 0.3 mL. The vaccine encodes the full-length spike (S) protein of the SARS-CoV-2 Omicron variant and harbours key mutations from Delta, Omicron BA.4/5 and BF.7, and was administered via intramuscular injection into the deltoid muscle of the upper arm.
干预措施: SYS6006 (Biological)
结局指标
主要结局
Geometric mean titer (GMT) of neutralizing antibodies in the immunogenicity subgroup
时间窗: 14 days after booster immunization
Measured in the immunogenicity subgroup at 14 days after booster immunization.
Incidence of serious adverse events (SAEs)
时间窗: Within 6 months after the booster administration
Serious adverse events monitored for 6 months after the booster administration.
次要结局
- Geometric mean concentration (GMC) of serum RBD-specific IgG(Day 14 after booster immunization)
- Geometric mean concentration (GMC) of serum RBD-specific IgG(Month 3 after booster immunization)
- Geometric mean concentration (GMC) of serum RBD-specific IgG(Month 6 after booster immunization)
- Geometric mean concentration (GMC) of serum RBD-specific IgA(Day 14 after booster immunization)
- Geometric mean concentration (GMC) of serum RBD-specific IgA(Month 3 after booster immunization)
- Geometric mean concentration (GMC) of serum RBD-specific IgA(Month 6 after booster immunization)
- ACE2-RBD binding inhibition rate(Day 14 after booster immunization)
- ACE2-RBD binding inhibition rate(Month 3 after booster immunization)
- ACE2-RBD binding inhibition rate(Month 6 after booster immunization)
- Antigen-specific T-cell response measured by ELISpot(Day 14 after booster immunization)
- Antigen-specific T-cell response measured by ELISpot(Month 3 after booster immunization)
- Antigen-specific T-cell response measured by ELISpot(Month 6 after booster immunization)