a Phase 3, Adaptive, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Immunogenicity, and Efficacy of the Nanocovax Vaccine Against COVID-19 in Volunteer Subjects 18 Years of Age and Older.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13,006
- 试验地点
- 1
- 主要终点
- Geometric mean of SARS-CoV-2 serum neutralizing titers by Plaque reduction neutralization test (PRNT) at each time point in a subset of participants
研究概览
简要总结
The purpose of this study is to evaluate the safety, immunogenicity, and efficacy of Nanocovax vaccine in volunteer subjects 18 years of age and older.
详细描述
This is a phase 3, adaptive, multicenter, randomized, double-blind, placebo control study to evaluate the safety, immunogenicity, and efficacy of the Nanocovax vaccine against COVID-19 in volunteer subjects 18 years of age and older.
Age stratified as 18-45, 45-60, and > 60 years of age.
The assessment of immunogenicity will be further expanded in a subset of Phase 3 (1000 participants).
Randomly assigned to vaccine or placebo group with a ratio of 2:1 (2 subjects injected with Nanocovax 25 mcg : 1 subject injected with placebo).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Be a male or female 18 years of age or older.
- •For females: Be of non-childbearing potential or willing to use appropriate contraceptive measures for 30 days prior to vaccination through 6 months after completion of the vaccine series.
- •Willingness to provide a signed, printed, and dated informed consent form.
- •Able and willing to participate in all activities in the clinical trial.
- •Participants with HIV, HBV, HCV should have a health record, determined to be stable for 6 months prior to the screening.
排除标准
- •Participants with unstable pre-existing medical conditions over the three months before enrollment (condition that has worsened to require hospitalization or significant changes in therapy).
- •Planned administration/administration of a vaccine not foreseen by the study protocol from within 45 days before the first dose of study vaccine.
- •Previous vaccination with any Covid-19 vaccine.
- •History of COVID-19 disease.
- •History of allergic reactions or anaphylaxis to previous immunizations or allergies to any components of the vaccine.
- •Planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase through 6 months after the second immunization.
- •History of bleeding disorders/hemostasis or use of anticoagulants.
- •Currently having cancer or undergoing cancer treatment.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose (inhaled and topical steroids are allowed).
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
25 mcg Dose
Intramuscular injection, two doses given 28 days apart
干预措施: Nanocovax (Biological)
Placebo
Intramuscular injection, two doses given 28 days apart
干预措施: Placebo (Biological)
结局指标
主要结局
Geometric mean of SARS-CoV-2 serum neutralizing titers by Plaque reduction neutralization test (PRNT) at each time point in a subset of participants
时间窗: days 0, 42 after vaccination
Percentage of participants reporting Serious adverse events or medically attended adverse events
时间窗: From dose 1 through one year after the last dose
Geometric mean of Anti-S IgG concentrations at each time point in a subset of participants
时间窗: days 0, 42, 180, 365 after vaccination
Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity
时间窗: From 14 days after the second dose of study intervention to the end of the study, up to 1 year
Per 1000 person-years of follow-up
次要结局
- Proportion of participants achieving ≥4-fold rise of Anti-S IgG at each time point in a subset of participants(days 0,42, 180, 365 after vaccination)
- Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} moderate to severe case of COVID-19(From 14 days after the second dose of study intervention to the end of the study, up to 1 year)
- Percentage of participants reporting unsolicited vaccine-related ≥ Grade 2 adverse events(28 days after each study vaccination)
- Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} asymptomatic case of COVID-19(From 14 days after the second dose of study intervention to the end of the study, up to 1 year)
- Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} mild case of COVID-19(From 14 days after the second dose of study intervention to the end of the study, up to 1 year)
- Percentage of participants reporting solicited local and systemic reactions(7 days after each study vaccination)
- Number of participants who death due to covid-19 confirmed with (RT-PCR) positive(From 14 days after the second dose of study intervention to the end of the study, up to 1 year)
- T-cell responses (intracellular cytokine staining)(days 0, 42 after vaccination)