EUCTR2014-002978-36-GB进行中（未招募）不适用
Vaccines Against Salmonella Typhi: a phase IIb, single centre, observer-blind, randomised controlled trial to assess the immunogenicity and protective efficacy of Vi conjugated (Vi-TCV) and unconjugated (Vi-PS) polysaccharide vaccines in preventing typhoid infection compared to a control vaccine (meningococcal ACWY), using a human challenge model of typhoid infection - Vaccines Against Salmonella Typhi (VAST)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 99
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 all of the following criteria to be considered eligible for the study:
- •1.Agree to give informed consent for participation in the study.
- •2.Aged between 18 and 60 years inclusive at time of enrolment.
- •3.In good health as determined by medical history, physical examination and clinical judgment of the study team.
- •4.Agree (in the study team's opinion) to comply with all study requirements, including capacity to adhere to good personal hygiene and infection control precautions.
- •5.Agree to allow his or her General Practitioner (and/or Consultant if appropriate), to be notified of participation in the study.
- •6.Agree to allow study staff to contact his or her General Practitioner to access the participant's vaccination records.
- •7.Agree to allow Public Health England to be informed of their participation in the study.
- •8.Agree to give his or her close contacts written information informing them of the participant's involvement in the study and offer them voluntary screening for Salmonella Typhi carriage.
- •9.Agree to have 24-hour contact with study staff during the four weeks post challenge and are able to ensure that they are contactable by mobile phone for the duration of the challenge period until antibiotic completion.
- •10. Agree to allow the study team to hold the name and 24-hour contact number of a close friend, relative or housemate who will be kept informed of the study participant’s whereabouts for the duration of the challenge period (from the time of challenge until completion of antibiotic course). This person will be contacted if study staff are unable to contact the participant.
- •11.Have internet access to allow completion of the e-diary and real-time safety monitoring.
- •12.Agree to avoid antipyretic/anti-inflammatory treatment from the time of challenge (day 0) until advised by a study doctor or until 14 days after challenge.
- •13.Agree to refrain from donating blood for the duration of the study
- •14.Agree to provide their National Insurance/Passport number for the purposes of TOPS registration and for payment of reimbursement expenses.
- •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 99
- •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 will not be enrolled if any of the following apply:
- •1.History of significant organ/system disease that could interfere with trial conduct or completion. Including, for example, but not restricted to cardiovascular, respiratory, haematological, endocrine, neurological, metabolic, autoimmune, renal, bladder or infectious disease. Biliary tract disease, including biliary colic, asymptomatic gallstones or previous cholecystectomy. Gastro-intestinal disease including requirement for antacids, H2-receptor antagonists, proton pump inhibitors or laxatives. Psychiatric illness requiring hospitalisation or known or suspected drug and/or alcohol misuse (alcohol misuse defined as an intake exceeding 42 units per week).
- •2.Have any known or suspected impairment of immune function, alteration of immune function, or prior immune exposure that may alter immune function to typhoid resulting from, for example:
- •a.Congenital or acquired immunodeficiency, including IgA deficiency
- •b.Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition
- •c.Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy
- •d.Receipt of immunoglobulin or any blood product transfusion within 3 months of study start.
- •e.History of cancer (except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ).
- •3.Moderate or severe depression or anxiety as classified by the Hospital Anxiety and Depression Score at screening or challenge that is deemed clinically significant by the study doctors .
- •4.Weight less than 50kg .
- •5.Presence of implants or prosthesis.
- •6.Anyone taking long-term medication (e.g. analgesia, anti-inflammatories or antibiotics) that may affect symptom reporting or interpretation of the study results.
- •7.Contraindication to ciprofloxacin or macrolide antibiotics.
- •8.Female participants who are pregnant, lactating or who are unwilling to ensure that they or their partner use effective contraception one month prior to challenge and continue to do so until two negative stool samples, a minimum of 2 weeks after completion of antibiotic treatment, have been obtained.
- •9.Full-time, part-time or voluntary occupations involving clinical or social work with direct contact with young children (defined as those attending pre-school groups or nursery or aged under 2 years), or clinical or social work with direct contact with highly susceptible patients or persons in whom typhoid infection would have particularly serious consequences (unless willing to avoid work until demonstrated not to be infected with S. Typhi in accordance with guidance from Public Health England and willing to allow study staff to inform their employer).
- •10.Full time, part time or voluntary occupations involving commercial food handling (involving preparing or serving unwrapped foods not subjected to further heating)
- •11.Close household contact with young children (defined as those attending pre-school groups, nursery or those aged less than 2 years )or individual(s) who is (are) immunocompromised.
- •12.Scheduled elective surgery or other procedures requiring general anaesthesia during the study period.
- •13.Participants who have participated in another research study involving an investigational product that might affect risk of typhoid infection or compromise the integrity of the study within the 30 days prior to
研究者
相似试验
进行中（未招募）
不适用
Assessment of Salmonella Typhim Vi(TM) vaccine (Sanofi Pasteur MSD) for the investigation of selective antibody deficiency to polysaccharide. - Assessment of Salmonella Typhim Vi VaccineEUCTR2010-018596-24-GBOxford Radcliffe Hospital NHS Trust
进行中（未招募）
1 期
Therapeutic vaccination: Phase I / II clinical study on patients randomized blinded to the experimental vaccine or placebo regimen. we want to evaluate the safety and the immunogenicity of a vaccine that includes a first administration of theChAdOx1.tHIVconsvX product and a second one with MVA.tHIVconsvX in HIV-1 positive adults treated early and able to control the infection for a long time.HIV InfectionCTIS2024-514581-39-00Ospedale San Raffaele S.r.l.33
招募中
2 期
Phase II Clinical Trial of Safety, Immunogenicity, and Mucosal Immunotherapy of Recombinant Lactococcus lactis Expressing Human Papillomavirus Type 16 E6/E7 Oncoprotein Vaccine in Women having Cervical Intraepithelial Neoplasia (CIN)Genital Wart.Anogenital (venereal) wartsA63.0IRCT20190504043464N2Iran University of Medical Sciences220
招募中
2 期
Trial on efficacy and safety of vaccination of newly diagnosed glioblastoma patients with the patient's own immune cells.2024-514820-18-00Heinrich-Heine-Universitaet Duesseldorf, Heinrich-Heine-Universitaet Duesseldorf136
招募中
2 期
Phase II trial of vaccination with lysate-loaded, mature dendritic cells integrated into standard radiochemotherapy in newly diagnosed glioblastomaC71Malignant neoplasm of brainDRKS00013248Heinrich-Heine-Universität Düsseldorf136