EUCTR2006-003796-12-BE进行中（未招募）不适用
A Phase I-II partially-blinded, randomized, dose- ranging study (10-30-90 mcg) to compare the safety and immunogenicity of GSK Biologicals’ candidate HIV vaccine F4co (p24-RT-Nef-p17), adjuvanted or not with AS01B, administered intramuscularly according to a vaccination schedule of 0, 1 month to healthy adult HIV seronegative volunteers, aged 18 to 40 years. - PRO HIV-005
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
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 18–40 years at the time of first vaccination.
- •Written informed consent obtained from the subject prior to any study procedure.
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards and return for follow-up visits).
- •Good general health without significant medical history, physical examination findings, or clinically significant abnormal laboratory results.
- •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.
- •Negative for antibodies against HIV-1, HIV-2 and negative for HIV p24 antigen, using Abbott AxSYM autoanalyser within 56 days (8 weeks) prior to enrolment.
- •Note: Subjects must be willing to accept HIV test results. Individuals who elect not to receive test results will not be enrolled.
- •Negative for anti-HBc Ab, HBsAg and anti-HCV Ab.
- •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
- •Women who are pregnant or breast-feeding.
- •Subjects with a history of, or current, alcohol or substance abuse.
- •The subject is at high risk of acquiring HIV according to the behavioural risk assessment questionnaire.
- •Morbid obesity
- •Previous inclusion in a HIV vaccines trial.
- •Receipt of live attenuated vaccines within 30 days of enrolment.
- •Receipt of medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) or allergy treatment with antigen injections (including a tuberculin skin test) within 14 days of study vaccine administration.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Prior receipt of HIV-1 vaccines or placebo in a previous HIV vaccine trial.
- •Receipt of blood products 120 days prior to HIV screening.
- •Receipt of immunoglobulin 120 days prior to HIV screening.
- •History of serious adverse reactions including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema and abdominal pain to vaccines.
- •History of serious allergic reaction to any substance requiring hospitalization or emergency medical care (e.g., Steven-Johnson syndrome, bronchospasm, or hypotension).
- •History of immunodeficiency or autoimmune disease.
- •History of malignancy (unless there has been surgical excision followed by a sufficient observation period, of at least 5 years, to give a reasonable assurance of sustained cure and which, in the estimate of the investigator, is not likely to recur 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 vaccination. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- •History of type I or type II diabetes mellitus including cases controlled with diet alone.
- •Note: A subject with past gestational diabetes is eligible.
- •Thyroid disease including history of thyroidectomy and diagnoses requiring medication.
- •Note: A subject not requiring thyroid medicine within the past 12 months is eligible.
- •Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever.
- •Asthma requiring daily steroid or long acting beta agonist prevention.
- •Unstable asthma defined as:
- •Sudden acute attacks occurring in less than three hours without an obvious trigger.
- •Hospitalization for asthma in the last two years.
- •Food- or wine-induced asthma
- •Known sensitivity to sulfites or aspirin
- •Bleeding disorder that was diagnosed by a physician; e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions.
- •Note: A subject who states that he or she has easy bruising or bleeding, but does not carry a formal diagnosis and has intramuscular (IM) injections and blood draws without any adverse experience is eligible.
- •History of any serious neurologic disorder or seizure
- •History of major congenital defect
- •History of chronic fatigue syndrome or fibromyalgia
- •Splenectomy
- •Hypertension.
- •Note: A subject with hypertension is eligible if he or she is controlled on medication and the documented blood pressure is less than 150/100.
- •Any medical, psychiatric or social condition, or occupational or other responsibility that, in the judgement of the investigator, would interfere wit
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