A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study Evaluating Safety and Immunogenicity of Influenza A Hemagglutinin Stabilized Stem Nanoparticle Vaccine Candidate in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Local and systemic reactogenicity of UFluA vaccination following one of four dose schedules.
研究概览
简要总结
The goal of this Phase 1, single- center, randomized, double blind, placebo-controlled dose-escalation study is to evaluate the safety, tolerability and immunogenicity of UFluA vaccine candidate at two dose levels and two schedules in healthy adult (18-45-year-old, inclusive) male and non-pregnant female subjects.
详细描述
A total of 60 healthy adult subjects will be enrolled in the study and followed through Day 337 (i.e., up to 48 weeks after first dose). Subjects will be enrolled into two study cohorts to receive either a low dose (Cohort 1; n=30 receives) or high dose (Cohort 2; n=30) of adjuvanted UFluA or placebo (saline), administered intramuscularly (IM) as single dose or as two doses (administered 21 days apart).
UFluA is comprised of DP-UFluA (1:1 A1-ssnp and A2-ssnp antigens) and contains aluminum hydroxide and CpG adjuvants.
Primary Objective:
To evaluate safety and tolerability of UFluA IM administration in healthy adults.
Secondary Objectives:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female adults (18-45 years of age, inclusive) at the Screening visit.
- •Body mass index of 18.5-32.0 kg/m^2 (inclusive) at the Screening visit.
- •Healthy, based on medical history (no chronic disease, no chronic therapy, no ongoing acute condition within four weeks prior to dosing as per PI [or designee] discretion), normal PE (no clinically significant findings in the opinion of the PI [or designee]), no clinically significant findings on screening electrocardiogram (ECG) and laboratory assessments in the opinion of the PI [or designee].
- •Females must not be pregnant or trying to become pregnant.
- •Both male and female subjects agree to acceptable forms of birth control. Male subjects must not donate sperm for the duration of the study.
排除标准
- •Enrollment in an interventional study and/or receipt of any investigational product within 30 days prior to screening visit or during the study.
- •Currently breastfeeding or planning to be breastfeeding during the study.
- •History of severe allergic reaction(s) or anaphylaxis.
- •Known allergy to any component of the vaccine.
- •History of any known immunodeficiency or immunocompromising condition that could impact response to administration of the investigational product (e.g., leukemia, lymphoma, malignancy, renal failure, asplenia, diabetes mellitus, alcoholic cirrhosis).
- •Receipt or anticipated receipt of blood products from 180 days prior to the Screening visit through 90 days following administration of IP.
- •Positive laboratory evidence of current infection at the Screening visit with HIV 1 and 2 (as determined by HIV 1/2 antibody test), HCV (as determined by HCV antibody test), or HBV [as determined by HBV surface antigen (HBsAg) test]. Note: positive anti-HCV antibody result along with a negative HCV PCR result would not be exclusionary.
- •Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG) based on the PI's (or designee's) review of tracing results at the Screening visit. [Non-pathologic sinus bradycardia (heart rate must be >40 beats per minute) is allowed].
- •Receipt or anticipated receipt of the seasonal influenza vaccination from up to 90 days prior to dosing and through up to 30 days following the last dose administration.
- •Receipt or anticipated receipt of any COVID-19 vaccine from up to 14 days prior to dosing and through up to 30 days following the last dose administration.
- •Receipt or anticipated receipt of any other vaccines from up to 90 days prior to dosing and through up to 30 days following last dose administration of investigational product.
- •Receipt or anticipated receipt of systemic immunomodulatory agents or other immune modifying drugs (including systemic corticosteroids exceeding 20 mg/day for ≥14 days) and antineoplastic agents from up to six months prior to dosing and through the entire duration of the study.
- •Planned medical procedure(s) that will impact study compliance during the follow-up period.
- •Positive urine drug screen test or any evidence of ongoing drug abuse or dependence (including alcohol), or recent history over the past five years of treatment for alcohol or drug abuse.
- •Planning to donate bone marrow, blood, and blood products from the time of screening until 3 months after receiving the last dose.
- •Have a tattoo/scar/birthmark or any other skin condition affecting the deltoid area that may interfere with injection site assessments.
- •History of H. pylori infection or documented iron deficiency within the past five years.
- •An opinion of the PI (or designee) that it would not be in the best interest of the subject to allow participation in the study.
研究组 & 干预措施
Cohort 1, 1A
Low dose (Day 1) plus placebo (Day 22)
干预措施: UFluA 20 µg each antigen/dose (Biological)
Cohort 1, 1A
Low dose (Day 1) plus placebo (Day 22)
干预措施: Placebo (Biological)
Cohort 1, 1B
Low dose (Day 1) plus low dose (Day 22)
干预措施: UFluA 20 µg each antigen/dose (Biological)
Cohort 1, 1C
Placebo (Day 1) plus Placebo (Day 22)
干预措施: Placebo (Biological)
Cohort 2, 2A
High dose (Day 1) plus placebo (Day 22)
干预措施: UFluA 60 µg each antigen/dose (Biological)
Cohort 2, 2A
High dose (Day 1) plus placebo (Day 22)
干预措施: Placebo (Biological)
Cohort 2, 2B
High dose (Day 1) plus high dose (Day 22)
干预措施: UFluA 60 µg each antigen/dose (Biological)
Cohort 2, 2C
Placebo (Day 1) plus Placebo (Day 22)
干预措施: Placebo (Biological)
结局指标
主要结局
Local and systemic reactogenicity of UFluA vaccination following one of four dose schedules.
时间窗: seven days after each vaccination
Incidences of local reactogenicity events up to 7 days after each vaccination. Incidences of systemic reactogenicity events up to 7 days after each vaccination.
Safety of the UFluA vaccine following one of four dose schedules as evaluated through adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and medically attended adverse events (MAAEs).
时间窗: 48 weeks
Incidence of AEs up to 4 weeks after last dose. Incidence of SAEs up to 48 weeks of study follow-up. Incidence of AESIs up to 48 weeks of study follow-up. Incidence of MAAEs up to 48 weeks of study follow-up.
次要结局
- Humoral immune response to A1 influenza antigen following UFluA vaccination.(up to 4 weeks after the last vaccination.)
- Anti-H. pylori ferritin immune response to UFluA vaccination.(up to 4 weeks after the last vaccination.)
- Anti-human ferritin immune response to UFluA vaccination.(up to 4 weeks after the last vaccination.)
- Humoral immune response to A2 influenza antigen following UFluA vaccination.(up to 4 weeks after the last vaccination.)