A Phase II, Randomized, Two Stage, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of an Intramuscular Influenza Vaccine (Multimeric-001) Injected to Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
This is a multi-center, randomized, two stage, double-blind, placebo-controlled administration study comprising 200 healthy participants.
详细描述
This is a Phase II multi-center, randomized, two stage, double-blind, placebo-controlled study comprising 200 participants. Eligible subjects will be randomized to receive one of the following administrations (as two single IM injections with an interval of 21 days between each injection Administration A: Prime twice with Adjuvanted Multimeric-001 500 mcg - 64 subjects.
Administration B: PBS (Placebo) twice - 32 subjects. Administration C: Adjuvanted PBS (Placebo)twice - 32 subjects. Participants from administrations A and B will be further immunized with a 15% dose of commercial seasonal trivalent vaccine for 2011 on day 81.
Administration D: Adjuvanted Multimeric-001 500 mcg coadministered once with 15% of TIV dose - 24 subjects. Administration E: Adjuvanted Multimeric-001 500 mcg coadministered once with 50% of TIV dose - 24 subjects Administration group F: PBS (Placebo) co-administered once with 50% of TIV dose - 24 subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Healthy males and females between the age of 18 and 49 years (inclusive).
- •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 (until termination visit) if female partner is not using an effective contraceptive method.
- •Subjects who are seronegative to at least one of the strains included in the seasonal vaccine against influenza for 2011.
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.
- •Subjects with known Guillain Barré Syndrome in the past.
- •Two or more hospitalizations within the last year prior to screening visit.
- •Known 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.
- •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 any 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
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: From day 0 until day 221
Number of Participants with Adverse Events possible/probably related to the study drug in each group were similar in the experimental and control groups.
Anti Multimeric-001 antibodies
时间窗: 21 days after second immunization with M-001
Direct Elisa assay to test the titer of human antibodies that recognize the Multimeric-001 protein. Humoral immunity was manifested 21 and 60 days post immunization by significantly elevated anti-M-001 IgG levels among subjects administered twice with adjuvanted M-001
次要结局
- Hemagglutination Inhibition (HAI) test for anti influenza antibodies(21 days post co administration of M-001 and TIV 50%)