PACTR201412000957310尚未招募未知
A phase Ib, open-label, clinical trial to evaluate the safety, tolerability and immunogenicity of the Ebola chimpanzee adenovirus vector vaccines, vrc-eboadc069-00-vp (Cad3-Ebo) and vrc-eboadc076-00-vp (Cad3-Eboz), in healthy adults in Kampala, Uganda
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 90
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 Year(s) 至 65 Year(s)（—）
- 性别
- All
入选标准
- •1. 18 to 65 years old.
- •2. Available for clinical follow-up through Week 48 after enrollment.
- •3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- •4. Must be willing to be taken home at enrollment visit and allow home visits if participant does not keep appointments
- •5. Must complete an Assessment of Understanding (AoU) prior to enrollment by answering 9 out of 10 questions at least once in 3 attempts.
- •6. Able to read (English or Luganda) and willing to complete the informed consent process.
- •7. Willing to donate blood for sample storage to be used for future research.
- •8. In good general health without clinically significant medical history.
- •9. Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) ¿ 40 within the 56 days prior to enrollment.
- •Laboratory Criteria within 56 days prior to enrollment:
- •10. Hemoglobin ¿ 11.0 g/dL for women; ¿12.5 g/dL for men.
- •11. White blood cells (WBC) = 2,500-12,000 cells/mm3.
- •12. WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.
- •13. Total lymphocyte count ¿ 800 cells/mm3.
- •14. Platelets = 125,000 ¿ 400,000/mm3.
- •15. Alanine aminotransferase (ALT) ¿ 1.25 x upper limit of normal.
- •16. Serum creatinine ¿ 1 x upper limit of normal.
- •17. Partial thromboplastin time (PTT) within institutional normal range.
- •18. Prothrombin time (PT) within institutional normal range.
- •19. HIV-uninfected as evidenced by a negative FDA-approved HIV diagnostic test.
- •Female-Specific Criteria:
- •20. Negative ¿-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment if woman is presumed to be of reproductive potential.
- •21. Agrees to use an effective means of birth control from at least 21 days prior to enrollment through 24 weeks after study vaccination if presumed to be of reproductive potential.
排除标准
- •1.Investigational Ebola or Marburg vaccine (other than the Ebola DNA vaccine delivered in RV 247) in a prior clinical trial or prior receipt of a cAd3 adenoviral vectored investigational vaccine.
- •2. Chronic use of immunomodulators and systemic glucocorticoids in daily doses of glucocorticoid equivalence > 20 mg of prednisolone, for periods exceeding 10 days. Non-steroidal anti-inflammatory drugs [NSAIDS] are permitted. Participants that have used less than the stated glucocorticoid dose may still be excluded at the Investigator¿s discretion.
- •3. Blood products within 112 days (16 weeks) prior to enrollment.
- •4. Investigational research agents within 28 days (4 weeks) prior to enrollment.
- •5. Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.
- •6. Subunit or killed vaccines within 14 days (2 weeks) prior to enrollment.
- •7. Current anti-tuberculosis prophylaxis or therapy.
- •Female-specific criteria:
- •8. Woman who is breast-feeding or planning to become pregnant during the first 24 weeks after study vaccine administration.
- •Volunteer has a history of any of the following clinically significant conditions:
- •9. Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
- •10. Clinically significant autoimmune disease or immunodeficiency.
- •11. Asthma that is not well controlled.
- •12. Diabetes mellitus (type I or II), with the exception of gestational diabetes.
- •13. Thyroid disease that is not well controlled.
- •14. A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
- •15. Idiopathic urticaria within the last 1 year.
- •16. Hypertension that is not well controlled.
- •17. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
- •18. Malignancy that is active or history of a malignancy that is likely
研究者
相似试验
招募中
Unknown
A Clinical Trial Evaluating the Efficacy and Safety of METi-101 in Patients with Refractory Metastatic Colorectal CancerKCT0008491MetiMedi Pharmaceuticals30
已完成
不适用
A phase I open-label clinical trial, evaluating the therapeutic vaccine hVEGF26-104/RFASE in patients with advanced solid tumorsadvanced cancerAdvanced solid tumor10027655NL-OMON47883Vrije Universiteit Medisch Centrum27
已完成
不适用
A phase I-II open label clinical trial, evaluating the efficacy and safety of administration of the therapeutic vaccine PEP-223/CoVaccine HT, to hormone treatment naive, immunocompetent subjects with T1-3, N0-1/x, M0 prostate cancer, eligible for hormone therapy.prostate cancerNL-OMON35662Pepscan Therapeutics B.V.12
进行中（未招募）
1 期
A phase I-IIa clinical trial, evaluating the therapeutic vaccine hVEGF26-104/RFASE in patients with advanced cancerAdvanced solid tumorsMedDRA version: 16.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864EUCTR2013-002663-25-NLVU University Medical Center27
已完成
1 期
A Clinical study on quadrivalent Human Papilloma virus vaccineCTRI/2017/02/007785Serum Institute of India Pvt Ltd47