ISRCTN15485902进行中（未招募）未知
Development of a live attenuated vaccine against Salmonella Paratyphi A
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 76
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37225278/ (added 25/05/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 23/03/2023:
- •1. Willing and able to give informed consent for participation in the study
- •2. Aged between 18 and 55 years inclusive at time of vaccination
- •3. In good health as determined by medical history, physical examination and clinical judgment of the study team
- •4. Willing to be available for all required appointments and if applicable to travel to vaccination and challenge site
- •5. 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
- •6. Agree to allow study staff to contact his or her GP or equivalent NHS databases to access the participant’s vaccination records, medical history and have their opinion solicited as to the participant’s appropriateness for inclusion
- •7. Agree to allow study staff to access NHS health records and participant identifiable data as required for study purposes
- •8. Agree to allow his or her GP (and/or Consultant if appropriate), to be notified of participation in the study
- •9. Agree to allow Public Health England to be informed of their participation in the study
- •10. Agree to give his or her close household contacts written information informing them of the participant's involvement in the study and offering them voluntary screening for S. Paratyphi A carriage
- •11. Agree to have 24-hour contact with study staff during the 4 weeks post-challenge and are able to ensure that they are contactable by mobile phone for the duration of the vaccination and challenge period until antibiotic completion
- •12. Have internet access to allow completion of the e-diary and real-time safety monitoring
- •13. Agree to avoid antipyretic/anti-inflammatory treatment from challenge until advised by a study doctor or until 14 days after challenge
- •14. Agree to refrain from donating blood for the duration of the study
- •15. Agree to provide their National Insurance/Passport number for the purposes of TOPS registration and for payment of reimbursement expenses
- •16. Participants must have received at least one dose of a SARS-CoV-2 vaccine that has been approved for use by the MHRA (or other national regulatory authority) >4 weeks prior to enrollment
- •17. Agree to not receive other vaccinations (eg Covid-19 vaccines) during the 7 days before and after study vaccination and during the 21 days post-challenge
- •Previous inclusion criteria as of 14/04/2022:
- •1. Willing and able to give informed consent for participation in the study
- •2. Aged between 18 and 55 years inclusive at time of vaccination
- •3. In good health as determined by medical history, physical examination and clinical judgment of the study team
- •4. Willing to be available in Oxford for all required appointments
- •5. 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
- •6. Agree to allow study staff to contact his or her GP to access the participant’s vaccination records, medical history and have their opinion solicited as to the participant’s appropriateness for inclusion
- •7. Agree to allow study staff to access NHS health records as required for study purposes
- •8. Agree to allow his or her GP (and/or Consultant if appropriate), to be notified of participation in the study
- •9. Agree to allow Public Health England to be informed of their participation in the study
- •10. Agree to give his or her close household contacts written information infor
排除标准
- •Updated 12/09/2023: Female participants changed to participants of childbearing potential.
- •Current exclusion criteria as of 23/03/2023:
- •1. History of significant organ/system disease that could interfere with trial conduct or completion. Including, for example, but not restricted to:
- •1.1. Cardiovascular disease including a diagnosis of hypertension
- •1.2. Respiratory disease
- •1.3. Haematological disease
- •1.4. Endocrine disorders
- •1.5. Renal or bladder disease, including history of renal calculi
- •1.6. Biliary tract disease, including biliary colic, asymptomatic gallstones or previous cholecystectomy
- •1.7. Gastro-intestinal disease including requirement for antacids, H2-receptor antagonists, proton pump inhibitors or laxatives
- •1.8. Neurological disease
- •1.9. Metabolic disease
- •1.10. Autoimmune disease
- •1.11. Psychiatric illness requiring hospitalisation
- •1.12. Known or suspected drug misuse
- •1.13. Known or suspected alcohol misuse (alcohol misuse defined as an intake exceeding 42 units per week)
- •1.14. Infectious disease
- •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:
- •2.1. Congenital or acquired immunodeficiency, including IgA deficiency
- •2.2. Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition
- •2.3. Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy.
- •2.4. Receipt of immunoglobulin or any blood product transfusion within 3 months of study start
- •2.5. History of cancer (except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ)
- •3. HLA-B27 positive
- •4. 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
- •5. Weight less than 50kg
- •6. Presence of implants or prosthesis
- •7. Anyone taking long-term medication (e.g. analgesia, anti-inflammatories or antibiotics) that may affect symptom reporting or interpretation of the study results
- •8. Contraindication to fluoroquinolones, macrolide antibiotics, co-trimoxazole or ceftriaxone
- •9. Family history of aneurysmal disease
- •10. Participants of childbearing potential who are pregnant, lactating or who are unwilling to ensure that they or their partner use effective contraception 30 days prior to vaccination and continue to do so until three negative stool samples have been obtained at least one week after completion of antibiotic treatment
- •11. Full-time, part-time or voluntary occupations involving:
- •11.1. 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
- •11.2. Clinical or social work with direct contact with highly susceptible patients or persons in whom typhoid infection would have particularly serious consequences
- •11.3. Commercial food handling (involving preparing or serving unwrapped foods not subjected to further heating)
- •11.4. (unless willing to avoid work from vaccination until demonstrated not to be infected with S. Paratyphi A after challenge by clearance samples in accordance with guidance from Public Health England and willing to allow study staff to inform their employer)
- •12. Close household contact with:
- •12.1. Young children (defined as those attending p
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