A Phase I/II, Randomized, Single-Blind, Placebo-Controlled Escalating Double-Dose, Safety and Priming Potential Study of an Intramuscular Influenza Vaccine (Multimeric-001) Injected to Elderly Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the safety, local and systemic tolerability and reactogenicity of Multimeric-001 vaccine when administered intramuscularly twice to elderly male and female subjects, using chemistry, CBC, fibrinogen, and urinalysis measurements.
研究概览
简要总结
This is a phase I/II, randomized, single-blind, placebo-controlled escalating double-dose study of the safety and priming potential of an intramuscular Influenza vaccine (Multimeric-001) injected to elderly volunteers.
详细描述
This is a Phase I/II single-center, randomized, placebo-controlled, single-blind, dose-escalation, double-dose administration study comprising two dosing cohorts (Cohort 1: 250 mcg M-001 per injection and Cohort 2: 500 mcg M-001 per injection) with 20 subjects in each cohort receiving either adjuvanted or non-adjuvanted formulations. The adjuvant used was Montanide ISA VG51. Cohort 3 with 20 subjects was administered placebo. After priming with M-001 or placebo, all participants were administered a boost of a conventional trivalent vaccine on day 42.
There was a minimum of 10 days interval between last dosing of the first injection to the last subject of the 250 μg cohort (Cohort 1) and first dosing of the first subject injection with 500 µg cohort (Cohort 2).
For each subject, the second injection was performed 21+2 days after his/her first injection, provided they were deemed fit to be dosed by a study physician.
The DSMB reviewed the safety data obtained from cohorts 1 and 2 before approving their second injection and before dose escalation.
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
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females between the age of 55 and 75 years (inclusive):
- •Healthy or treated for any or all of the following conditions:
- •Hypertension, under control with standard medications
- •Hyperlipidemia, medically treated
- •Subjects who provide written informed consent to participate in the study.
- •Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- •Haematology, chemistry and urinalysis values with no clinical significance or do not reflect a medical condition which, according to the physician's judgment, might confound the results of the study or pose additional risk to the subject by participation in the study.
- •Female of childbearing age must agree to use an acceptable method of contraception and male subjects should use a condom throughout the study period (including the follow up- where applicable) if female partner is not using an effective contraceptive method.
排除标准
- •Known history of significant medical disorder, which in the investigator's judgment, might confound the results of the study or pose additional risk to the subject by participation in the study.
- •Renal dysfunction.
- •Chronic cardiovascular system disorders (except hypertension adequately controlled by standard medications).
- •Diabetes mellitus.
- •Subjects with known Guillain Barré Syndrome in the past.
- •Two or more hospitalizations within the last year prior to screening visit.
- •Bleeding disorders including hemophilia or thrombocytopenia, or treatment with anticoagulant therapy (risk of bleeding with intramuscular injection).
- •Immunocompromised patients and those receiving concomitant immunosuppressive therapy; or other immune modulating drugs including chronic steroid treatment.
- •Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus within eight months prior to the screening visit.
- •Administration of any vaccine 30 days before the screening visit.
- •Known hypersensitivity to previous influenza vaccination.
- •Use of an influenza antiviral medication within 4 weeks of vaccination.
- •Known hypersensitivity and/or allergy to any drug or vaccine.
- •Known hypersensitivity to egg proteins (eggs or egg products), chicken proteins, or any of the vaccine components, in particular, neomycin, formaldehyde, and octoxinol 9,
- •Known history of drug or alcohol abuse.
- •Any clinically significant abnormality upon physical examination or in the clinical laboratory tests at screening visit which, according to the physician's judgment, might confound the results of the study or pose additional risk to the subject by participation in the study.
- •Increased liver enzymes more than 2.5 times above the upper reference level.
- •Positive serology for HIV, HCV antibody or HBsAg.
- •Any acute medical situation (e.g. acute infection, ongoing flu symptoms) with or without fever within 48 hours of vaccination, which is considered of significance by the Principal Investigator.
- •Pregnant or lactating women at entry to study and those who are unwilling to agree to continue to use acceptable methods of contraception for two months after completion of the study (if applicable).
- •Positive blood pregnancy test on screening.
- •Subjects who participated in another clinical study within 30 days prior to study entry.
- •Subjects who are non-cooperative or unwilling to sign consent form.
结局指标
主要结局
To assess the safety, local and systemic tolerability and reactogenicity of Multimeric-001 vaccine when administered intramuscularly twice to elderly male and female subjects, using chemistry, CBC, fibrinogen, and urinalysis measurements.
时间窗: From day 0 until termination visit
The Multimeric-001 vaccine exhibits a positive safety profile. The number of subjects reporting adverse events (AEs) after treatment with active vaccines was similar to respective placebo cohorts. Overall AE frequencies for each active group were similar to those of placebo counterparts.
次要结局
- To characterize the immune response(21 days after second immunization with M-001 and 21 days after TIV boost)
- To monitor cellular immune responses(21 days after second M-001 immunization)
- To obtain preliminary data on the contribution of the adjuvant(21 days after second M-001 immunization and 21 days after TIV boost)
- To obtain preliminary evidence about the efficacy of M-001 as a primer(21 days after TIV boost)