CTRI/2017/02/007755已完成1 期
Phase-I open label, dose-escalation clinical trial to evaluate the safety, tolerability and immunogenicity of Chikungunya vaccine in healthy adults of 18 to 50 years age - Chikungunya vaccine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
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
入选标准
- •General Criteria:
- •>=18 and <=50 yrs inclusive on the day of screening
- •Able and willing to complete informed consent process with understanding of the purpose and procedures of the study
- •Medical history and physical examination without clinically significant findings at the time of screening
- •Haematological and biochemical values either within institutional normal range and accompanied by physician approval
- •Agree to keep a daily record of symptoms for the duration of the study
- •Available for clinical follow-up throughout the study period via telephone contact as well as clinic visits
- •Female specific criteria:
- •If female of child bearing potential- have a negative urine pregnancy test result within 24 hrs of the scheduled first vaccination.
排除标准
- •Female specific criteria:
- •Woman who is breast feeding or planning to become pregnant during the study period.
- •General Criteria:
- •History of suspected or confirmed Chikungunyafever
- •(Case definition for Suspected Chikungunya:
- •A subject meeting both the clinical and epidemiological criteria.
- •Clinical criteria: acute onset of fever >38.5°C and severe arthralgia/arthritis not explained by other medical conditions.
- •Epidemiological criteria: residing or having visited epidemic areas, having reported transmission within 15 days prior to the onset of symptoms.
- •Case definition for Confirmed Chikungunya:
- •Asubject meeting thelaboratory criteria of positive ELISA test for CHIKV IgG.)
- •Clinically significant abnormal clinical laboratory values including blood pressure( >140 mmHg systolic and >90 mmHg diastolic) when 3 measurements are taken 30 min apart , in seating position and at rest
- •Body mass index (BMI) >= 25 [BMI will be calculated as weight in Kilograms/(height in metres)2]
- •Test positive for HIV or Hepatitis B infection
- •History of cardiovascular disease
- •History of immune deficiency or autoimmune disease
- •Have active or history of arthritis (joint swelling, pain, tenderness, warmth or erythema) within the last 6 months from date of screening
- •Have an active or history of malignant conditions including haematological malignancy
- •Have a history of degenerative neurological disease (e.g. GuillainBarre Syndrome, multiple sclerosis)
- •Have received any vaccination within 4 weeks prior to the vaccination in this study
- •Have received blood transfusion or immunoglobulin within 30 days prior to vaccination in this study
- •Have a history of serious reactions to any vaccines that preclude receipt of study vaccinations as determined by the investigator
- •Have asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids
- •Have diabetes mellitus (type I or II), with the exception of history of gestational diabetes
- •Have received any investigational drug in 6 weeks prior to screening
- •Is currently participating in any form of clinical trial that involves intervention.
- •Is likely to participate in any other clinical trial during the study period.
研究者
相似试验
进行中（未招募）
不适用
An open-label, early stage, dose rising study of 2B3-101 in patients with solid tumors and brain metastases or recurrent malignant glioma.Solid tumors and brain metastases or recurrent malignant glioma, HER2-positive adenocarcinoma of the breast with brain metastasesMedDRA version: 14.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10006128Term: Brain metastasesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-001119-30-NLto-BBB technologies B.V.82
进行中（未招募）
不适用
An open-label, early stage, dose rising study of 2B3-101 in patients with solid tumors and brain metastases or recurrent malignant glioma.Solid tumors and brain metastases or recurrent malignant glioma, HER2-positive adenocarcinoma of the breast with brain metastases,MedDRA version: 17.0Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: LLTClassification code 10006128Term: Brain metastasesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10059514Term: Small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-001119-30-BEto-BBB technologies B.V.129
招募中
不适用
An open-label, Phase I/IIa, dose escalating study of 2B3-101 in patients with solid tumors and brain metastases or recurrent malignant glioma.or recurrent malignant gliomasolid neoplasmssolid tumors and brain metastases10006291NL-OMON39207to-BBB technologies B.V.45
招募中
1 期
A study to test different doses of BI 1810631 in people with different types of advanced cancer (solid tumours with changes in the HER2 gene).JPRN-jRCT2031210165Takeuchi Yoshito96
进行中（未招募）
1 期
A study to evaluate the safety and tolerability of ascending doses of UCART19 given as a single infusion in patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukaemia (B-ALL) and to determine the maximum tolerated dose (MTD).Patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukaemia (B-ALL).MedDRA version: 20.0Level: LLTClassification code 10060390Term: Leukaemia lymphoblastic acuteSystem Organ Class: 100000004864EUCTR2016-000296-24-GBInstitut de Recherches Internationales Servier (I.R.I.S)30