A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Adults Who is COVID-19 naïve or Had Previous COVID-19 Infection or Completed Inactivated or mRNA COVID-19 Vaccination.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Medically Attended AEs (MAAEs)
研究概览
简要总结
This is a Phase I, open label, dose-escalation study of three dose levels of the SARS-CoV-2 spike antigen administered intramuscularly (IM) in combination with a fixed dosage of PIKA adjuvant vaccine to evaluate the safety, tolerability, and immunogenicity of PIKA COVID-19 vaccine candidate in healthy individuals aged 18 years and above. The study will comprise of two arms. Arm A will include subjects who never been infected with COVID-19 or with a history of COVID-19 infection for not less than 6 months prior to study participation and Arm B will include subjects who will be receiving PIKA vaccine as a booster vaccination dose to COVID-19 primary vaccination of inactivated or mRNA Covid 19 vaccines.
详细描述
This is a Phase I, open label, dose-escalation study of three dose levels of the SARS-CoV-2 spike antigen administered intramuscularly (IM) in combination with a fixed dosage of PIKA adjuvant vaccine to evaluate the safety, tolerability, and immunogenicity of PIKA COVID-19 vaccine candidate in healthy individuals aged 18 years and above. The study will comprise of two arms. Arm A will include subjects who had never been infected with COVID-19 or with a history of COVID-19 infection for not less than 6 months prior to study participation and Arm B will include subjects who will be receiving PIKA vaccine as a booster vaccination dose to COVID-19 primary vaccination of inactivated or mRNA Covid 19 vaccines.
Arm A: There will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. A total of 45 subjects will be enrolled in Arm A. Subjects in Group 1-3 will receive two doses of PIKA COVID-19 vaccine via IM administration on Days 0 and 7. Fifteen eligible subjects in each dose group.
Arm B: There will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. A total of 90 subjects will be enrolled in Arm B which will be divided into Arm B1 (45 subjects) and Arm B2 (45 subjects). Arm B1 will enroll subjects who received Inactivated vaccines and will comprise of 15 subjects per dose (45 subjects). Arm B2 will enroll subjects who received mRNA vaccines and will comprise of 15 subjects per dose (45 subjects). Subjects in Group 1-3 of Arm B1 and Arm B2 will receive one booster dose of PIKA COVID-19 vaccine via IM administration on Days 0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- •Exclusion Criteria of Arm A:
- •History of COVID-19 of less than 6 months prior to enrollment
- •Received partial or complete course of any type of COVID-19 vaccine.
- •History of close contact with a person infected or suspected of COVID-19 not less than 14 days prior to study enrollment.
- •Positive test for SARS-CoV-2 infection, including but not limited to RT-PCR /Rapid Antigen Test at screening, before the first dose (Day 0) and before the second dose (Day 7).
- •For more exclusion criteria, please contact the investigator or sponsor.
- •Exclusion Criteria of Arm B:
- •History of close contact with a person infected or suspected of COVID-19 not less than 14 days prior to study enrollment.
- •Positive test for SARS-CoV-2 infection, including but not limited to RT-PCR/RAT at screening, before the first dose (Day 0) .
- •Have received three and more doses of COVID-19 vaccine.
- •Pregnant or breastfeeding or intending to become pregnant or father children within the projected duration of the trial.
- •For more exclusion criteria, please contact the investigator or sponsor.
结局指标
主要结局
Medically Attended AEs (MAAEs)
时间窗: through study completion, an average of 6 months.
Incidence of Medically Attended AEs (MAAEs).
Solicited systemic AEs
时间窗: 7 days after each vaccination.
Incidence of solicited systemic AEs.
AEs of special interest (AESIs)
时间窗: through study completion, an average of 6 months.
Incidence of AEs of special interest (AESIs).
Solicited local adverse events,
时间窗: 7 days after each vaccination.
Incidence of solicited local adverse events (AEs).
Unsolicited AEs
时间窗: 28 days after each vaccination.
Incidence of unsolicited AEs.
Serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs)
时间窗: through study completion, an average of 6 months.
Incidence of serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs).
次要结局
未报告次要终点