ISRCTN85988131进行中（未招募）Unknown
BIO-004: Reprogramming T cells for disease tolerance in falciparum malaria
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Participant inclusion criteria as of 30/04/2024:
- •1. Healthy, malaria-naïve adult aged 18 to 45 years old
- •2. Able and willing (in the Investigator’s opinion) to comply with all study requirements
- •3. Willing to allow the Investigators to access the volunteer’s electronic medical records or discuss the volunteer’s medical history with their GP
- •4. Participants of childbearing potential only: must practice continuous effective contraception for the duration of the study
- •5. Able and willing to provide written informed consent to participate in the trial
- •6. Negative haemoglobinopathy screen (including sickle cell disease and alpha and beta thalassaemia) and normal G6PD levels
- •7. Agreement to permanently refrain from blood donation during and after the study, as per current UK Blood Transfusion and Tissue Transplantation Services guidelines
- •8. Reachable (24 hours a day) by mobile phone during the period between CHMI and completion of anti-malarial treatment
- •9. Willing to take a curative anti-malarial treatment regimen following CHMI
- •10. Able to answer all questions on the informed consent questionnaire correctly at the first or second attempt
- •11. Able to travel to CCVTM
- •12. Willingness to be registered on the TOPS database (The Overvolunteering Prevention System; www.tops.org.uk).
- •Previous participant inclusion criteria:
- •1. Healthy, malaria-naïve, CMV-seropositive adult aged 18 to 45 years old
- •2. Able and willing (in the Investigator’s opinion) to comply with all study requirements
- •3. Willing to allow the Investigators to access the volunteer’s electronic medical records or discuss the volunteer’s medical history with their GP
- •4. Participants of childbearing potential only: must practice continuous effective contraception for the duration of the study
- •5. Able and willing to provide written informed consent to participate in the trial
- •6. Negative haemoglobinopathy screen (including sickle cell disease and alpha and beta thalassaemia) and normal G6PD levels
- •7. Agreement to permanently refrain from blood donation during and after the study, as per current UK Blood Transfusion and Tissue Transplantation Services guidelines
- •8. Reachable (24 hours a day) by mobile phone during the period between CHMI and completion of anti-malarial treatment
- •9. Willing to take a curative anti-malarial treatment regimen following CHMI
- •10. Able to answer all questions on the informed consent questionnaire correctly at the first or second attempt
- •11. Able to travel to CCVTM
- •12. Willingness to be registered on the TOPS database (The Overvolunteering Prevention System; www.tops.org.uk).
排除标准
- •Participant exclusion criteria as of 30/04/2024:
- •1. Red blood cells negative for the Duffy antigen/chemokine receptor (DARC) (this exclusion criterion is for Group 2 only)
- •2. Body weight < 50 kg or Body Mass Index (BMI) < 18.0 at screening
- •3. History of clinical malaria (any species) or previous participation in any malaria vaccine trial or CHMI
- •4. History of yellow fever virus infection or prior receipt of YFV
- •5. Travel to a clearly malaria endemic locality during the study period or within the preceding six months
- •6. Use of immunoglobulins or blood products (e.g. blood transfusion) in the last three months
- •7. Receipt of any vaccine (except the COVID-19 vaccine or flu) in the 30 days preceding enrolment, or planned receipt during the study period
- •8. Receipt of a COVID-19 or flu vaccine within 2 weeks before the day of CHMI or planned receipt of a COVID-19 or flu vaccine prior to expected completion of anti-malarial treatment (around 2 to 3 weeks after day of challenge based on experience in previous P. falciparum CHMI studies to date)
- •9. Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period
- •10. Concurrent involvement in another clinical trial involving an investigational product or planned involvement during the study period
- •11. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- •12. Previous thymectomy or known or suspected thymic disorder
- •13. Hypersensitivity reactions to eggs, chicken proteins or any component of Stamaril
- •14. Any history of anaphylaxis in reaction to vaccinations
- •15. Any confirmed or suspected bleeding disorders
- •16. Current use of anticoagulant medication e.g. low molecular weight heparin, warfarin, apixaban, edoxaban
- •17. Known allergy to local anaesthetics e.g. lidocaine
- •18. Use of systemic antibiotics with known anti-malarial activity within 30 days of CHMI (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin)
- •19. Use of anti-malarials within 30 days of CHMI
- •20. Any clinical condition known to prolong the QT interval
- •21. History of cardiac arrhythmia, including clinically relevant bradycardia
- •22. Disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia
- •23. Family history of congenital QT prolongation or sudden death
- •24. An estimated ten-year risk of fatal cardiovascular disease of > = 5% at screening, as determined by the Systematic Coronary Risk Evaluation (SCORE) shown in Appendix B in the protocol
- •25. Use of medications known to have a potentially clinically significant interaction with Riamet
- •26. Any other contraindications/known hypersensitivities to Riamet or Malarone
- •27. History of sickle cell anaemia, sickle cell trait, thalassaemia or thalassaemia trait, G6PD deficiency or any haematological condition that could affect susceptibility to malaria infection
- •28. Pregnancy, lactation or intention to become pregnant during the study
- •29. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- •30. History of serious psychiatric condition that may affect participation in the study
- •31. Any other serious chronic illness requiring hospital specialist supervision
- •32. Suspected or known current alcohol misuse as defined b
研究者
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