EUCTR2011-003653-26-GB进行中（未招募）不适用
A phase II, single-centre, randomised, single-blind, study to evaluate Vi-CRM197 against historical unvaccinated controls in a healthy adult challenge model, with a Vi-PS vaccine control arm. - Understanding immunity after typhoid vaccination
Clinical Trials and Research Governance0 个研究点目标入组 36 人开始时间: 2011年12月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
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
- •Participants must satisfy each of the following criteria to be eligible for study inclusion: • Male or female aged 18 - 60 years inclusive. • Willing and able to give informed consent for participation after the nature of the study has been explained. • In good health as determined by: a) Medical history b) History-directed physical examination c) Clinical judgment of the investigators. • Have an abdominal ultrasound scan result documented demonstrating no evidence of gallbladder pathology or cholelithiasis/gall stones. • Able and willing (in the opinion of the investigators) to comply with all study requirements, including capacity for good personal hygiene • Able and willing to remain in proximity to Oxford for 14 days after challenge or until well on antibiotic treatment, at the discretion of the lead study doctor, nurse or chief investigator. • Willing to allow their general practitioner and/or hospital consultant (if relevant), to be notified of participation in the study. • Willing to allow the Health Protection Unit to be informed of participation in the study. • For those involved in provision of health or social care to vulnerable groups only – willing to allow their employer or occupational health department to be notified of participation in the study • Willing to give their close contacts (defined as someone who is likely to have been exposed to the excreta of a challenged participant, usually a household or sexual contact) letters informing them of the participants involvement in the study and offering the contacts screening for S Typhi carriage. • Agree to refrain from blood donation (to the National Blood Service) indefinitely in the future if they are diagnosed with typhoid fever. • Be willing to have 24-hour contact with study staff during the four weeks post-challenge, and to keep a 24-hour contact informed of their whereabouts.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •The participant may not enter the study if ANY of the following apply: • Are unwilling or unable to give written informed consent to participate in the study. • Have previously received any typhoid vaccine • Have previously been resident in a typhoid endemic country for >6 months • Have previously been diagnosed with probable or confirmed typhoid infection • Have previously been challenged with S. Typhi or enrolled in a typhoid challenge study. • Have received vaccination with a vaccine containing either CRM197 or diphtheria toxoid within the past 12 months • Have had previous confirmed infection due to C. diphtheriae in the past 5 years • Have any known or suspected impairment or alteration of immune function, resulting from, for example: Congenital or acquired immunodeficiency (including IgA deficiency); Receipt of immunosuppressive treatment/therapy such as chemo- or radiotherapy within the preceding 6 months or long-term systemic corticosteroid therapy; Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition; Autoimmune disease. • History of significant cardiovascular disease (including congenital heart disease, previous myocardial infarction, valvular heart disease (or history of rheumatic fever), previous bacterial endocarditis, history of cardiac surgery (including pacemaker insertion), personal or family history of cardiomyopathy or sudden adult death) • History of significant respiratory disease • History of significant endocrine disorder • History of significant renal or bladder disease • History of biliary tract disease • History of significant gastrointestinal disease (including inflammatory bowel disease, abdominal surgery, coeliac disease, liver disease(including hepatitis B or C infection, (as determined by detected hepatitis B surface antigen or hepatitis C antibody), or requirement for H2-receptor antagonists, proton pump inhibitors or laxatives) • History of significant neurological disease • History of significant metabolic disease • History of significant haematological diagnosis • History of psychiatric illness requiring hospitalisation, current known or suspected drug or alcohol misuse • Moderate or severe depression or anxiety as classified by the Hospital Anxiety and Depression Score at challenge, that is deemed clinical significant by the Chief Investigator or consultant physician. If elevated scores are due to temporary life-events, the questionnaire may be repeated after resolution of the event with a view to inclusion if normalised • History of significant infectious disease (e.g., previous or current schistosomiasis infection, history of positive syphilis serology (determined by non-treponemal test)) • History of non-benign cancer (except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ) • Presence of any implants or prostheses (e.g., artificial joints, pacemakers) • Any clinically significant abnormal finding on biochemistry or haematology blood tests or urine analysis • Known hypersensitivity to any component of the vaccine or hypersensitivity to ciprofloxacin (or other fluoroquinolone antibiotics) or azithromycin (or other macrolides). Hypersensitivity to other antibiotics will be reviewed on a case by case basis • Female participant who is pregnant, lactating or who is unwilling to ensure that they or their partner use effective contraception 28 days prior to vaccination and continue to do so until two negative stool samples obta
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