ISRCTN60284968已完成1 期
A phase I, double-blind, randomised, placebo-controlled trial to assess the safety and feasibility of administering plasmid DNA carrying multiple HIV-1 genes together with dermal electroporation
Swedish Institute for Infectious Disease Control (SMI) (Sweden)0 个研究点目标入组 48 人开始时间: 2010年9月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
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
- •1. Men and women 18 to 40 years of age
- •2. Negative antibody/antigen test for HIV infection
- •3. Willing to undergo HIV testing
- •4. Residents in Stockholm, at low risk of HIV and willing to remain so for the duration of the study
- •5. Low risk of HIV infection defined as:
- •5.1. No history of injecting drug use in the previous ten years
- •5.2. No gonorrhoea, chlamydia or syphilis during the last six months
- •5.3. No high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months
- •6. Willing to undergo a genital infection screening if need arises
- •7. Participants will agree to practice effective contraception from study entry until 4 months after the last immunization
- •8. Willing to practice safer sex for the duration of the study to avoid sexually transmitted infections
- •9. Good health as determined by medical history, physical examination and clinical judgment
- •10. No grade 1 or higher routine laboratory parameters
- •10.1. Hb >10.5g/dL
- •10.2. White blood cell count <13.000/mm3
- •10.3. Neutrophils >1500/mm3
- •10.4. Lymphocytes >1.0
- •10.5. Platelets >120.000/mm3
- •10.6. CD4 >400/mm3
- •10.7. Glucose 2.5-7.0 mmol/L
- •10.8. Bilirubin <1.25xULN
- •10.9. Aspartate Aminostransferase (AST) <1.25xUNL
- •10.10. Alanine Aminotransferase (ALT) <1,25xUNL
- •10.11. Alkaline Phosphatase (ALP) <1.25xUNL
- •10.12. Creatinine <1.0xUNL
- •10.13. Complete urinalysis (UA). If microscopic UA confirms evidence of hematuria or proteinuria = 1+, the volunteer is ineligible)
- •11. Availability for the duration of the study
- •12. Able to give fully informed consent at screening visits 1 and 2
排除标准
- •1. Have active tuberculosis or other systemic infectious process, such as laboratory detection of tuberculosis bacteria, Hepatitis antigen, acute Hepatitis C, acute or active syphilis
- •2. Have a history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention, autoimmune disease, severe eczema
- •3. Have history of psychiatric, medical and/or substance abuse problems during the past 6 months that the investigator believes would adversely affect the volunteer's ability to participate in the trial
- •4. History of grand-mal epilepsy, or currently taking anti-epileptics
- •5. Have received blood products or immunoglobulin in the past 3 months
- •6. Are receiving ongoing therapy with immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy
- •7. Have used experimental therapeutic agents within 30 days of study entry
- •8. Have ECG deviations that indicate heart disease or would make interpretation of vaccine induced effect difficult
- •9. Have received any live, attenuated vaccine within 60 days of study entry (NOTE: Medically indicated subunit or killed vaccines [e.g., Hepatitis or influenza] are not exclusionary but should be given at least 2 weeks before or after HIV immunization to avoid potential confusion of adverse reactions)
- •10. Have previously received an HIV vaccine
- •11. History of severe local or general reaction to vaccination defined as
- •11.1. Local: extensive, indurated redness and swelling involving most of the antero-lateral thigh or the major circumference of the arm, not resolving within 72 hours
- •11.2. General: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours.
- •12. Are study site employees who are involved in the protocol and may have access to the immunogenicity results
- •13. Unlikely to comply with protocol
研究者
相似试验
已完成
1 期
Assessment of the safety and distribution of NVB302 in healthy volunteersClostridium difficile infectionInfections and InfestationsISRCTN40071144ovacta Biosystems Limited (UK)72
已完成
不适用
A phase I, double-blind, randomised, placebo-controlled study, in three parts (parts A, B and C) to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BIM23B065 administered subcutaneously as single and multiple ascending doses to young healthy male subjectsgigantism.10021112acromegalyNL-OMON41949Centre for Human Drug Research80
进行中（未招募）
不适用
A study to evaluate reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated liquid human rotavirus (HRV) vaccine 444563, in healthy infants.EUCTR2012-001481-16-Outside-EU/EEAGlaxoSmithKline Biologicals50
已完成
不适用
A Phase I, double-blind, randomised, placebo-controlled, multiple dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of two dosages of estetrol in healthy meProstate cancerNL-OMON43503Pantarhei Oncology45
招募中
1 期
A Phase I, double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetesThis is a phase I clinical trial which includes only healthy subjects and subjects with prediabetes.DRKS00030865niversitätsklinikum Schleswig-Holstein, Campus Kiel66