TCTR20220706004尚未招募1 期
Safety, Virological and Immunological Assessment of the Controlled Dengue Human Infection Model in Thailand
Division of Dengue Hemorrhagic Fever Research, Faculty of Medicine Siriraj Hospital, Mahidol University0 个研究点目标入组 5 人开始时间: 2022年7月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
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
- 年龄范围
- 18 Years 至 30 Years（—）
- 性别
- All
入选标准
- •1. Thai healthy volunteers, aged between 18 to 30 years old and weight is greater than or equal to 45 kg and have Thai language literacy.
- •2. Don't have any history of previous dengue, zika or Japanese encephalitis virus infection
- •3. Have not given blood donation in the past 3 months
- •4. Education: higher than high school
- •5. Display flavivirus immunity profile defined by the standard PRNT 50% (PRNT50) as follows: flavivirus naive is defined as the PRNT50 titer against
- •DENV1 < 1:5
- •DENV2 < 1:5
- •DENV3 < 1:5
- •DENV4 < 1:5
- •ZIKV < 1:5
- •6. Willingness to participate in the study as evidenced by signing the informed consent document.
- •7. Female participants of childbearing potential should be agreed to either abstinence or use at least one primary form of contraception from the time of screening for rDEN2delta30-7169 administration until 1 month after complete course of Dengvaxia vaccination (Study Day 568).
排除标准
- •1. For female participants: Currently pregnant, as determined by positive beta-human choriogonadotropin (HCG) test or breast-feeding, and given birth or abortion within 6 months.
- •2. History of previous acute undifferentiated febrile illness leading to hospitalization in the past 3 months
- •3. Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the subject's ability to understand and cooperate with the requirements of the study protocol.
- •4. Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by subject history.
- •5. History of a severe allergic reaction or anaphylaxis
- •6. Severe asthma (emergency room visit or hospitalization within the last 6 months).
- •7. Any known immunodeficiency syndrome.
- •8. Having any pre-existing medical conditions consist of thrombocytopenia, autoimmune disease and cancer based on history, physical examination, and/or laboratory studies.
- •9. Current use of anticoagulant medications (this includes anti-platelet medication such as aspirin or non-steroidal anti-inflammatory medications).
- •10. Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following vaccination. An immunosuppressive dose of corticosteroids is defined as equal or greater than 10 mg of a prednisone equivalent per day for equal or greater than 14 days.
- •11. Asplenia
- •12. Receipt of any vaccine within 28 days or a killed vaccine within 14 days prior to receive virus administration, or anticipated receipt of any vaccine during the 28 days following rDEN2delta30-7169 administration.
- •13. Receipt of blood products within the past 6 months, including transfusions or immunoglobulin, or anticipated receipt of any blood products or immunoglobulin during the 28 days following rDEN2delta30-7169 administration.
- •14. Previous receipt of a flavivirus vaccine (licensed or experimental).
- •15. Screening laboratory values of Grade 1 or above (as defined in this protocol) for ANC (<750 /mm3), Platelet (<100,000 /mm3), PT (> 1.25 x ULN), APTT (> 1.66 x ULN), ALT (>2.5 x ULN) and serum creatinine (> 1.3 x ULN OR Increase to >1.3 x participant's baseline)
- •16. Body temperature higher than 37.5 degree Celsius
- •17. HIV infection, as indicated by anti-HIV screening assays.
- •18. Hepatitis C virus (HCV) infection, as indicated by anti-HCV screening assays.
- •19. Hepatitis B virus (HBV) infection, as indicated by hepatitis B surface antigen (HBsAg) and/or anti-HBc screening.
- •20. Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, or would render the subject unable to comply with the protocol.
研究者
相似试验
招募中
不适用
Assessment of clinical, virological and immunological characteristics in high-risk COVID-19 patients with mild to moderate symptoms – a non-interventional cohort studyU07.1COVID-19, virus identifiedDRKS00031503Charité Universitätsmedizin Berlin, Klinik m.S. Infektiologie und Pneumologie225
尚未招募
4 期
Assessment of the protection offered by single dose of COVID-19 vaccines in individuals previously affected with COVID-19CTRI/2021/10/037099Indian Council of Medical research ICMR
尚未招募
4 期
A Clinical study to evaluate the immune response and safety of double dose of live attenuated Chicken Pox vaccine among Indian children : 12 month follow up studyCTRI/2016/11/007452Wockhardt Ltd305
招募中
1 期
A study to Evaluate Immunogenicity, Safety and Tolerability of a Single Dose of ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2COVID-19 diseaseMedDRA version: 23.1Level: PTClassification code 10084457Term: COVID-19 immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2021-005504-36-DKBavarian Nordic A/S4,000
已完成
3 期
Safety and immunogenicity of rabies vaccines in animal bite cases administered using new one week intradermal regimeCTRI/2012/12/003230Department of Community Medicine Kempegowda Institute of Medical Sciences KIMS80