Immunogenicity and Safety Study in Ambulatory Adults of a Single Intramuscular Dose of SpikoGen Vaccine as a Heterologous or Homologous Booster Dose Following Completion of a Primary Course of Covid-19 Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Seroconversion
研究概览
简要总结
The purpose of the study is to assess the effectiveness of Spikogen vaccine when used as a 3rd or 4th dose booster in adults who have been previously vaccinated with any Covid-19 vaccine types, including mRNA vaccine, adenoviral vector vaccines, recombinant protein vaccines, or inactivated virus vaccines.
详细描述
Currently in Australia, mRNA, adenoviral vector and recombinant protein vaccines have provisional approval for use as 3rd or 4th booster doses. This study will provide important data on the use of Spikogen as an alternative recombinant protein booster vaccine. The study will provide data in ambulatory adults on the safety and effectiveness of Spikogen vaccine when administered as a single intramuscular booster dose in those who previously vaccinated with mRNA vaccine in comparison to those immunised with other Covid-19 vaccine platforms.
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
- •Able to provide written informed consent
- •Males or females 18 years of age or older
- •Have previously had a primary course of Covid-19 vaccine with the most recent dose no less than 3 months previously.
- •Understand and are likely to comply with planned study procedures and be available for all study visits.
- •Exclusion Criteria
- •Allergy to Spikogen vaccine or one of its components, e.g. polysorbate
- •Have received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial reporting period.
- •Any serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.
排除标准
- 未提供
研究组 & 干预措施
SpikoGen vaccine
Single booster dose of SpikoGen Covid-19 vaccine
干预措施: SpikoGen vaccine (Biological)
结局指标
主要结局
Seroconversion
时间窗: Between baseline and 4 weeks post the booster dose
Proportion of study participants who seroconvert (4-fold or greater rise in serum spike antibody) by primary vaccine group
SARS-CoV-2 infection
时间窗: Between time of administration of booster dose and through study completion, an average of 3 months
Frequency of SARS-CoV-2 infections in study participants by primary vaccine group, age, gender, co-morbidities, and past infection
Seroconversion in participants with and without evidence of past infection
时间窗: Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Spike antibody seroconversion in baseline nuclear protein antibody positive versus negative participants by primary vaccine group
Safety assessment 1
时间窗: Occurring within 7 days after booster dose.
Frequency of Adverse events by primary vaccine group
Seroprotection
时间窗: Between baseline and 4 weeks post the booster dose
Proportion of study participants who achieve a spike protein neutralisation titer of 32 or greater by primary vaccine group
Geometric mean titer fold change
时间窗: Between baseline and 4 weeks post the booster dose
Increase in Geometric mean titer of spike neutralisation antibodies by primary vaccine group
Safety assessment 2
时间窗: Between time of administration of booster dose and through study completion, an average of 3 months
Frequency of Serious Adverse events by primary vaccine group
Antibody durability
时间窗: Between time of administration of booster dose and through study completion, an average of 3 months
The proportion of subjects who remain seroprotected throughout the duration of the study including broken down by primary vaccine group.
Seroprotection in participants with and without evidence of past infection
时间窗: Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Spike antibody seroprotection in baseline nuclear protein antibody positive versus negative participants by primary vaccine group
Spike antibody GMT in participants with and without evidence of past infection
时间窗: Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Spike antibody GMT in baseline nuclear protein antibody positive versus negative participants by primary vaccine group.
次要结局
- Antibody correlates of protection(Baseline and 4 weeks post the booster dose, and through study completion, an average of 3 months)