Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of the Safety, Tolerability, and Immunogenicity of Intramuscular CodaVax-H1N1 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Safety and Tolerability by Assessing Percentage of Participants with Adverse Events
研究概览
简要总结
This study is a Phase 1, 2-part, randomised, double-blind, controlled, clinical trial to evaluate the safety and immune response of CodaVax-H1N1 in healthy adults aged 18 to 49 years. Participants will be enrolled in autumn 2022 (southern hemisphere) and followed through the 2022 influenza season (Part A) or enrolled in autumn 2023 and followed through the 2023 influenza season (Part B). Participants will be screened within 28 days of randomization, and eligible participants in Part A will be enrolled into 1 of 3 sequential cohorts and randomised to receive a single dose of CodaVax-H1N1, placebo (normal saline), or licenced injectable seasonal influenza vaccine (Flucelvax Quad). Each subsequent cohort will include a higher dose of CodaVax H1N1 than the previous cohort, in addition to placebo and the licensed injectable seasonal influenza vaccine. In Part B, 24 eligible participants will be enrolled into 1 of 2 sequential cohorts and randomised to receive a single IM dose of CodaVax-H1N1 or placebo.
详细描述
This study is a Phase 1, 2-part, randomised, double-blind, controlled, clinical trial to evaluate the safety and immune response of CodaVax-H1N1 in healthy adults aged 18 to 49 years. Participants will be enrolled in autumn 2022 (southern hemisphere) and followed through the 2022 influenza season (Part A) or enrolled in autumn 2023 and followed through the 2023 influenza season. Participants will be screened within 28 days of randomization, and eligible participants in Part A will be enrolled into 1 of 3 sequential cohorts and randomised to receive a single dose of CodaVax-H1N1, placebo (normal saline), or licensed injectable seasonal influenza vaccine (Flucelvax Quad). Each subsequent cohort will include a higher dose of CodaVax H1N1 than the previous cohort, in addition to placebo and the licensed injectable seasonal influenza vaccine. In Part B, 24 eligible participants will be enrolled into 1 of 2 additional sequential cohorts and randomised to receive a single IM dose of CodaVax-H1N1 or placebo.
Participants will record reactogenicity events (local events, systemic events, and temperature) in a daily diary for 7 days after the dose. Each participant will be contacted by telephone on the day after dosing for safety assessment and review of the diary data. Participants will return to the clinic on Days 4, 8, 29, 91, and 181 for safety and immune response assessments.
All adverse events and concomitant medications will be recorded from signing of the informed consent form (ICF) to 28 days postdose. After 28 days until the end of the study, only medically attended adverse events (MAAEs), new onset chronic illnesses (NCIs), serious adverse events (SAEs), immunosuppressive medications, blood products like transfusions or infusions, and vaccines will be recorded. A complete physical examination will be performed at Screening, and targeted and symptom-driven physical examinations will be performed predose on Day 1, 2 hours postdose, and at each postdose visit through Day 91. Vital signs will be measured at the same time points. An electrocardiogram (ECG) will be performed at Screening and on Day 29.
A serum sample will be collected predose and on Days 29, 91, and 181 for measurement of immune response.
A whole blood sample will be collected predose and on Day 8 and PBMCs isolated for measurement of T-cell response.
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 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2
- •In good health with no history, or current evidence, of clinically significant medical conditions
- •Negative SARS-CoV-2 test predose on Day 1
- •For all women, negative pregnancy test
- •Agreement to comply with conditions to prevent the spread of genetically modified organisms (GMOs)
排除标准
- •Pregnant or lactating women or women who plan to become pregnant through Day 29
- •Inadequate venous access for repeated phlebotomy
- •History of severe reaction to vaccination
- •Receipt of any licenced or investigational influenza vaccine within 6 months before Day 1
- •Receipt of any live vaccine within 30 days before Day 1
- •Tattoo, skin reaction, or other condition at the injection site that would interfere with assessment of local reactogenicity
研究组 & 干预措施
CODA-VAX H1N1
Live Attenuated Vaccine administered by Intramuscular Injection
干预措施: CODA-VAX H1N1 (Biological)
Flucelvax Quad
Licensed Injectable Seasonal Influenza Vaccine
干预措施: Flucelvax Quad (Biological)
Saline
Normal Sterile Saline for Intramuscular Injection
干预措施: Saline (Other)
结局指标
主要结局
Safety and Tolerability by Assessing Percentage of Participants with Adverse Events
时间窗: Adverse events (AEs) from Day 1 to Day 29
Percentage of participants with adverse events
Safety and Tolerability by Assessing Percentage of Participants with Reactogenicity Events
时间窗: Reactogenicity events from Day 1 to Day 7
Percentage of participants with reactogenicity events
Safety and Tolerability by Assessing Percentage of Participants with MAAEs, NCIs, and SAEs.
时间窗: MAAEs, NCIs, SAEs from Day 1 to Day 181
Percentage of participants with MAAEs, NCIs, and SAEs.
次要结局
- Humoral Immunogenicity(HAI assay titre against A/California/07/2009 and the current seasonal influenza vaccine H1N1 and H3N2 strains measured in samples collected on Days 1, 29, 91, and 181)