A Multicenter, Double-Blind, Randomized, Placebo-Controlled Probe Study With an Additional Open-Label Control Arm to Evaluate the Safety and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine in Subjects With Chronic Hepatitis C Virus Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE)
研究概览
简要总结
A Study to assess the general safety and tolerability of the administration of a 3-dose prime/boost regimen of the MRKAd5 HIV-1 gag vaccine (V520) in subjects with chronic hepatitis C virus infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who is of reproductive potential agrees to use a acceptable method of birth control through week 52 of the study
排除标准
- •Subject weighs less than 110 lbs.
- •Subject has received treatment for hepatitis C virus infection in the 3 months before enrollment in this study or is anticipated to begin treatment with in 1 year after enrollment
- •Subject has any history of anaphylaxis or allergy to vaccine components
- •Subject has any history of anaphylaxis or allergy to Tetanus and Diphtheria Toxoids Adsorbed (Td)
- •Subject has clinical signs suggestive of cirrhosis
- •Subject has had a liver biopsy showing bridging fibrosis or cirrhosis
- •Subject is HBsAg positive
- •Subject has other known chronic liver disease
- •Subject has evidence of hepatocellular carcinoma on liver biopsy
- •Subject has had a liver transplant or is anticipated to have a liver transplant within 1 year of enrollment
- •Subject has been vaccinated with a live virus vaccine in the past 30 days
- •Subject has been vaccinated with an inactive virus vaccine in the past 14 days
- •Female subject is pregnant or breast-feeding, Male subject is planning to impregnate
- •Subject has active drug or alcohol abuse
- •Subject is at high risk for HIV infection
研究组 & 干预措施
MRKAd5 HIV-1 gag vaccine 1x10^9 vp/dose
Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
干预措施: MRKAd5 HIV-1 gag vaccine (V520) (Biological)
MRKAd5 HIV-1 gag vaccine 1x10^10 vp/dose
Participants were to be administered MRKAd5 HIV-1 gag 1x10^10 vp/dose (V520) on Day 1, Week 4, and Week 26.
Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10^10 vp/dose.
干预措施: MRKAd5 HIV-1 gag vaccine (V520) (Biological)
Placebo
Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
干预措施: Comparator: Placebo (Biological)
Open Label Tetanus and Diptheria Toxoids Adsorbed
Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only.
Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group.
干预措施: Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed (Biological)
结局指标
主要结局
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE)
时间窗: up to Week 78 (52 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs
Serious and non serious clinical (systemic and injection-site AEs), and laboratory AEs were collected. Systemic and laboratory AEs reflect any unfavorable \& unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. Vaccine-related AEs are those determined by the investigator to be possibly, probably, or definitely related to the administration of the vaccine.
次要结局
- Number of Participants With Systemic and Laboratory Adverse Events (AE)(up to Week 260 (234 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs)
- Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen(Week 30 (4 weeks after boost injection))