Reactogenicity, Safety and Immunogenicity of an Recombinant Universal Influenza Vaccine Uniflu in Healthy Volunteers From 18 to 60 Years Old
试验速览
- 阶段
- 1 期
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events in treatment vs control group
研究概览
简要总结
This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty four (54) volunteers 18-60 years of age with a dose escalation.
All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval between treatments.
详细描述
This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty four (54) volunteers 18-60 years of age.
All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval between treatments.
Subjects will undergo screening procedures within 6 days prior to first vaccination which will include medical history, vital signs, physical examination and safety blood and urine lab tests.
On the first treatment visit, eligible subjects will undergo pre-dose physical examination,vital signs, ECG, a blood sample will be drawn for circulating IgE. They receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle. The subjects will remain under medical supervision for 72 hrs, after that time they will be released from the Clinical research center.
The second treatment will take place 21 days after the first vaccination. Procedures will be the same as on the first treatment visit.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18 to 60 years old.
- •Healthy that verificated by vital signs, physical examination, blood and urine lab tests
- •Body mass index (BMI) from 18.5 to 30.5 weight >50 kg
- •Written informed consent.
- •Consent to the use of effective contraceptive methods throughout the study period.
- •Negative pregnancy test (for fertile women), consent to the use of effective contraceptive methods throughout the study period.
- •Exclusion criteria
- •Participation of a volunteer in any other study in the last 90 days; any vaccination in the last 30 days;
- •Vaccination within 6 months before the start of the study (including during participation in other clinical trials).
- •Symptoms of respiratory illness in the last 3 days.
- •Symptoms of any acute in the screening period.
- •Administration of immunoglobulins or other blood products for the last 3 months.
- •Taking immunosuppressive drugs and / or immunomodulators within 6 months before the start of the study.
- •Hypersensitivity or allergic reactions to the administration of any vaccine in medical history.
- •The presence of anaphylactic reactions, angioedema or other SAE to the administration of any vaccine in medical history.
- •Allergic reactions to vaccine components.
- •Seasonal allergy (at autumn period).
- •Acute or chronical desease or pathology from the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, genitourinary and endocrine systems, which may influence the evaluation of the results of the study, in the anamnesis and also according to the screening examination data
- •Leukemia or any other blood disease or malignancy of other organs.
- •Thrombocytopenic purpura or bleeding disorders in medical history.
- •Seizures in medical history.
- •The presence or suspected presence of various immunosuppressive or immunodeficient state, including HIV infection.
- •Hepatitis B and C.
- •Tuberculosis.
- •Regular past or current use of narcotic drugs.
- •Pregnancy or breastfeeding.
- •Any conditions which may influence the evaluation of the results of the study, in the anamnesis and also according to the screening examination data.
排除标准
- 未提供
研究组 & 干预措施
LD Universal Influenza Vaccine Uniflu
low dose of Uniflu vaccine 0.5 ml (20 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals
干预措施: LD Universal Influenza Vaccine Uniflu (Biological)
HD Universal Influenza Vaccine Uniflu
high dose of Uniflu vaccine 0.5 ml (40 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals
干预措施: HD Universal Influenza Vaccine Uniflu (Biological)
Placebo
saline 0.5 ml
干预措施: Placebo (Biological)
结局指标
主要结局
Number of participants with adverse events in treatment vs control group
时间窗: 42 days (from first visit to termination visit for each subject)
Estimation the quantity of adverse events in treatment group vs control group
次要结局
- Assessment of Immunogenicity(Time Frame: at days 1, 21, 42.)