Phase 1b Clinical Study to Investigate the Safety and Immunogenicity of the Sing2016 (A/Singapore/INFIMH-16-0019/2016) M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- FluGen Inc
- 入组人数
- 122
- 试验地点
- 6
- 主要终点
- Treatment Emergent AEs During 7 Days After Experimental Treatment
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a healthy adult population age 50 to 85 years.
详细描述
This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a healthy adult population age 50 to 85 years. Eligible subjects will be randomized 2:1 to receive one administration of Sing2016 M2SR or placebo followed by a dose of age-appropriate licensed inactivated influenza vaccine (IIV) at least 28 days later. Two lead-in groups of adults ages 50-64 years (Cohort 1) and 65 - 85 years (Cohort 2) will be followed by enrollment of an expansion group, ages 65 - 85 (Cohort 3). Safety data will be reviewed between enrollment of successive cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be willing and able to provide written informed consent.
- •Cohort 1: age 50-64 years at time of enrollment; Cohorts 2 and 3: age 65 to 85 years at time of enrollment (signing of informed consent form).
- •Subject willing to adhere to the requirements of the study and willing and able to communicate with the Investigator and understand the requirements of the study
- •Healthy adults and those with stable chronic conditions as determined by medical history, physical examination, vital signs, clinical safety laboratory examinations and clinical judgment of the investigator to be eligible for study inclusion.
- •Women of child-bearing potential must agree to abstain from sexual intercourse or to correctly use an acceptable method of contraception from 30 days prior to vaccination until 30 days after the last study vaccination.
- •Women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to vaccination with investigational product.
排除标准
- •Any acute or chronic physical or mental condition that would limit the subject's ability to complete the study, increase risk of study participation or participant, or may interfere with interpretation of study results as based on the assessment by the Investigator.
- •Acute or chronic medical condition or history of a medical condition that, in the opinion of the Investigator, would render the study procedures unsafe or would interfere with the evaluation of the responses.
- •Abnormal screening hematology or chemistry value per the FDA Guidance: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials.
- •Currently receiving, or planned to receive during the study, any immunosuppressive therapy.
- •Had a flu-like illness, influenza treatment, influenza vaccination, or prophylactic influenza viral drug administered in the previous 6 months before investigational product administration.
- •Females who are pregnant or nursing; non-vasectomized males, with female partners of child-bearing potential, who are unwilling to use a highly effective form of contraception from the time of enrollment through at least 28 after administration of the investigational product.
- •History of receipt of any investigational vaccine within 28 days of visit 1 or investigational drug within the past six months. An exception is made for receipt of a Covid-19 vaccine whether licensed or under emergency use authorization (EUA) as long as the second dose was given at least 28 days prior to dosing with investigational vaccine.
- •Acute febrile illness within 72 hours prior to investigational product vaccination
- •Receipt of blood/plasma products or immunoglobulin within 6 months before administration of the investigational product or planned for during the period of study participation.
- •Planned donation of blood or blood product of at least approximately 1 pint within 3 months after investigational product administration.
结局指标
主要结局
Treatment Emergent AEs During 7 Days After Experimental Treatment
时间窗: Day 1 to Day 8
The number and percentage of study participants who experience local (at the dose administration site) and systemic (throughout the body) reactions during the 7 days after administration of investigational M2SR vaccine or placebo. Solicited and unsolicited signs and symptoms were reported as AEs after review by the Investigator or designee, either separately using the corresponding Medical Dictionary for Regulatory Activities (MedDRA) terminology of the sign or symptom or combined using the appropriate term.
Treatment Emergent AEs During 28 Days After Experimental Treatment
时间窗: Day 1 to Day 29
The number and percentage of study participants who experience a treatment emergent AE during the 28 days after administration of investigational M2SR vaccine or placebo. Unsolicited signs and symptoms were reported as AEs after review by the Investigator or designee, either separately using the corresponding MedDRA terminology of the sign or symptom or combined using the appropriate term.
SAEs Through 28 Days After Licensed IIV Treatment
时间窗: Time of enrollment through 28 days after receipt of IIV where the IIV was administered an average of 49 days post-IP and with an interval up to 91 days later.
The number and percentage of study participants who experience SAEs from the time of study entry through 28 days after receipt of IIV. Unsolicited signs and symptoms were reported as AEs after review by the Investigator or designee, either separately using the corresponding MedDRA terminology of the sign or symptom or combined using the appropriate term.
次要结局
未报告次要终点