EUCTR2009-011529-15-GB进行中（未招募）不适用
A Phase II Prospective, Randomised, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of the Influenza Vaccine GHB11L1 Administered Intranasally Against a Controlled Influenza Virus Challenge in Healthy Adults.
AVIR Green Hills Biotechnology Research Development Trade AG0 个研究点目标入组 80 人开始时间: 2009年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Male subjects aged 18 to 45 years.
- •2. In general good health determined by a screening evaluation =45 days prior to
- •double-blind IMP administration and on the day of double-blind IMP administration
- •3. Males should be willing to use a reliable form of contraception approved by the
- •Investigator (use of a condom plus spermicide, or a female partner fulfilling the
- •following criteria: hysterectomy or bilateral tubal ligation, oral or implanted
- •contraceptive use, intrauterine device or barrier method plus spermicide) from
- •immunisation phase baseline (Day -28±2) until 28 (±2) days after the influenza
- •4. Negative human immunodeficiency virus (HIV), hepatitis B and C antibody screen
- •5. Negative drugs of abuse, alcohol and nicotine screen
- •6. Seronegative for influenza A/Brisbane/59/07(H1N1) (antibody titres <1:10 detected in HAI assay).
- •7. Have not been vaccinated for influenza virus in 2006/2007 and/or later seasons or
- •had a known influenza infection in the current or latest season.
- •8. Give written informed consent to participate after reading the Consent Form and
- •after having adequate opportunity to discuss the study with an Investigator or
- •qualified deputy.
- •9. Willing and able to communicate with the Investigator and understand the
- •requirements of the study, including willingness to enter and remain in quarantine
- •until free of influenza infection.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A complete list of exclusion criteria is given in the respective clinical study protocol:
- •1. Presence or evidence of significant acute or chronic, uncontrolled medical or
- •psychiatric illness (subjects with uncomplicated chronic diagnoses stable and treated
- •for =3 months e.g. mild hypertension well-controlled with medication, may be
- •enrolled – provided the condition and its therapy are known not to be associated with an immunocompromised state or increased risks of complications of influenza)
- •2. Health care workers (including doctors, nurses, medical students and allied
- •healthcare professionals) anticipated to have patient contact within two weeks of
- •viral challenge. Healthcare workers who volunteer should not work with patients until
- •14 days after challenge or until their symptoms are fully resolved (whichever is the
- •longer). In particular, any health care workers who work in units housing severely
- •immunocompromised patients (e.g. bone marrow transplant units).
- •3. Presence of household member or close contact (for an additional two weeks after
- •discharge from the isolation facility) who is: less than 3 years of age; has any known
- •immunodeficiency; is receiving immunosuppressant medications; is undergoing or
- •soon to undergo cancer chemotherapy within 28 days of challenge; diagnosed with
- •emphysema or COPD; elderly residing in a nursing home, suffering from severe lung
- •disease or medical condition including but not exclusive to the conditions listed in
- •Section 18.4; or a transplant (bone marrow or solid organ) organ recipient
- •4. Any laboratory test which is abnormal and which is deemed by the Investigator(s) to be clinically significant, including blood chemistry, haematology or urinalysis.
- •5. Venous access inadequate for phlebotomy demands of the study
- •6. Clinically significant abnormality on ECG
- •7. Any history during adulthood of asthma, chronic obstructive pulmonary disease
- •(COPD) or any chronic lung condition of any aetiology
- •8. Smokers who have smoked at any time in the three months prior to study entry or
- •have a significant history of any tobacco/cannabis use at any time (tobacco: 10 pack
- •year history = one box a day for 10 years)
- •9. Any anatomic or neurologic abnormality impairing the gag reflex or associated with a risk of aspiration, or history suggestive of such a problem, or any clinically relevant abnormal paranasal anatomy
- •10. Subject is type I or II diabetic
- •11. History or evidence of autoimmune disease or known impaired immune
- •responsiveness (of any cause)
- •12. Receipt of systemic glucocorticoids (in a dose =5 mg prednisone daily or equivalent),antiviral drugs, immunoglobulins (Igs) or blood transfusions within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months
- •13. Presence of any febrile illness or symptoms of upper or lower tract respiratory
- •infection on the day of double-blind IMP administration (such subjects may be reevaluated for enrolment after resolution of the illness). On Day 0, before challenge,
- •symptoms of grade 1, mild”, are acceptable
- •14. Presence of any febrile illness or symptoms of upper viral respiratory infection:
- •Existing on the day of challenge or between admission for Influenza challenge and
- •administration of the challenge inoculum. Such subjects may be re-evaluated for
- •enrolment after resolution of the illness
- •Within 2 weeks prior to challenge or if challenge is set to occur during November,
- •December, January, February, or March if there are any symptoms suggestive of
研究者
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