PACTR2009040001075080Other2 期
A phase I/II trial to assess safety & immunogenicity of a plasmid DNA-MVA prime boost HIV-1 vaccine candidate among volunteers in DaresSalaam, Tanzani
Swedish Institute for Infectious Disease Control (SMI)0 个研究点目标入组 0 人开始时间: 2008年11月26日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
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
- •18-40 years
- •Willing to be counseled & HIV tested
- •Negative HIV Ag/Ab ELISA
- •Informed consent
- •Minimum 7 years of 1° Education.
- •Resident in Dar es Salaam
- •At low risk of HIV, (absence of: sexual partner with HIV, partner with unknown HIV serostatus and unwilling to use protection in sexual relations, partner known to be at high risk for HIV, >1 sexual partner in last 6 months, alcoholic (>35 units/week), STI in past 6 months).
- •Assurances for birth control measures till 4 months after last vaccination
- •Negative UPT
- •Willingness for safe sex practice
- •Good health by clinical & lab parameters: (FBG <7.8 mmol/l, Hb >10.5g/dl, WBC count >1,300/mm3, Granulocytes >6.4/ mm3, Lymphocytes >1.0/ mm3, Platelets >120,000/ mm3, CD4 >400cells/mm3, RBG 2.5-7.0 mmol/L; if elevated, then a FBG <7.8 mmol/l, Bilirubin <1.25 x uln, ALT <1.25 x uln, Creatinine <1.25 x uln, -ve/trace urine dipstick for protein and blood)
排除标准
- •Active TB/other systemic infection
- •Positive HBsAg
- •Active syphilis
- •Immunodeficiency/chronic illness
- •Autoimmune disease
- •Severe eczema
- •Psychiatric/substance abuse problem in past 6 months
- •Grand-mal epilepsy, or current use of anti-epileptics
- •Blood/Blood products/immunoglobulins use in past 3 months
- •Immunosuppressive therapy.
- •Experimental therapeutic agents within 30 days of study entry
- •Any live, attenuated vaccination within 60 days of study entry
- •Receipt of an HIV candidate vaccine.
- •Severe local or general reaction to vaccination
- •Lactating mothers
- •Study site employees
- •Protocol non-compliance
研究者
相似试验
已完成
不适用
TaMoVac-01PACTR2010050002122368Swedish Institute for Infectious Disease Control120
招募中
1 期
A phase I trial to assess safety and immunogenicity of an HLAII-targeted DNA vaccine against influenza H7N9Influenza prophylaxisCTIS2022-500706-18-01Oslo University Hospital Hf30
招募中
不适用
A Phase I trial to assess safety and immunogenicity of i.d. DNA priming and i.m. MVA boosting in healthy volunteers in MozambiqueHIV/AIDSPACTR201106000304583Swedish Institute for Infectious Disease Control24
招募中
不适用
TaMoVaC IIPACTR201211000435126Swedish Institute for Infectious Disease Control198
已完成
1 期
Study to evaluate safety and possible adverse reactions, especially serious, with a vaccine for measles and rubella in healthy subjects.Measles and RubellaRBR-9hckj4Bio-Manguinhos/Fiocruz/MS