EUCTR2006-002095-18-BE进行中（未招募）1 期
A phase II randomized, double-blind (observer blind), adjuvant justification study of RTS,S/AS01B and RTS,S/AS02A, candidate malaria vaccines, administered according to a 0, 1, 2 months schedule in malaria-naive adults aged 18 to 45 years. - Malaria-048
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- All
入选标准
- •A male or female between, and including, 18 and 45 years of age at the time of the first vaccination.
- •Written informed consent obtained from the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Have clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and differential at screening.
- •Be seronegative for human immunodeficiency virus 1 and 2 (HIV 1/2) antibodies, hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibodies.
- •Have anti HBs titre >=10mIU/ml at screening.
- •If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
- •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
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •Any history of clinical malaria.
- •Known exposure to malaria parasites within the previous 12 months.
- •Planned travel to a malaria endemic region during the study period.
- •History of allergic reactions (significant Immunoglobulin [IgE]-mediated events) or anaphylaxis to previous immunizations.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Personal history of autoimmune disease or subjects who describe a first-degree relative with clearly documented autoimmune disease. Exclusionary medical histories will include the following diagnoses: systemic lupus erythmatosus, rheumatoid arthritis, mixed connective tissue disease, scleroderma, vasculitis, and multiple sclerosis.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- •Major congenital defects or serious chronic illness(es).
- •History of any neurologic disorders or seizures.
- •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / axillary temperature <37.5°C (99.5°F).
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- •History of previous exposure to experimental products containing AS02A, AS01B or related products containing MPL and QS21.
- •Pregnant or lactating female.
- •History of chronic alcohol consumption and/or drug abuse.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
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