A Probe Study of the Safety, Tolerability, and Immunogenicity of a 1-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine Versus the ALVAC-HIV (vCP205) Vaccine in Healthy Adults Who Previously Received a 3-Dose Regimen of MRKAd5, Ad5, or Placebo in Merck V520 Protocols 007 or 012
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 250
- 主要终点
- Safety and tolerability of ALVAC-HIV or MRKAd5 HIV-1 vaccine in subjects who previously received a 3-dose regimen of Ad5 HIV-1 gag vaccine measured by number of injection-site adverse experiences (AE), non serious systemic AE, lab AE, serious AE.
研究概览
简要总结
This study is designed to determine whether patients previously primed with Ad5 of MRKAd5 HIV-1 gag vaccine respond better when boosted with ALVAC-HIV vaccine than when boosted with MKRAd5 HIV-1 gag vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject was previously enrolled in Merck HIV Vaccine study V520 Protocol 007 or 012, and received the complete 3-dose regimen during participation
- •Subject is in good general health
- •Subject is not infected with HIV
- •Subject agrees not to donate blood during the first 52 weeks of the study
- •Subject agrees not to donate sperm during the first 12 weeks of the study
- •Subject who is of reproductive potential agrees to use an acceptable method of birth control through Week 12 of the study
排除标准
- •Subject has been administered immune globulin or blood product 3 months prior to receiving study vaccination
- •Subject has been vaccinated with a live virus vaccine in the past 30 days
- •Subject has been vaccinated with an inactivated vaccine in the past 14 days
- •Subject has an active medical disease
- •Subject is taking daily required prescription drugs
- •Female subject is pregnant, breastfeeding or expecting to conceive
- •Subject is positive for HIV
- •Subject has used injection drug within the past year
- •Subject has a sexual partner that is infected with HIV
- •Subject has a sexual partner that is an active injection drug user
- •Subject has been treated for or diagnosed with a new sexually transmitted disease in the past 6 months
- •Subject engaged in unprotected intercourse with more than 2 persons in the previous 6 months
- •Subject engaged in protected intercourse with more than 4 persons in the previous 6 months
- •Subject has previously participated in an HIV vaccine clinical trial (other than Merck V520 Protocols 007 and 012)
- •Subject weighs less than 110 lbs.
- •Subject has a recent history of alcohol abuse
- •Subject intends to donate blood in the first 52 weeks of the trial
研究组 & 干预措施
Stratum 1
Placebo recipients in the parent protocol (Merck V520 Protocols 007 or 012) will receive ALVAC-HIV Vaccine
干预措施: Comparator: ALVAC-HIV vaccine (Biological)
Stratum 2
Nonresponders who received active vaccine in parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine
干预措施: Comparator: ALVAC-HIV vaccine (Biological)
Stratum 3
Low responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine
干预措施: Comparator: ALVAC-HIV vaccine (Biological)
Stratum 4
High responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine
干预措施: Comparator: ALVAC-HIV vaccine (Biological)
Stratum 4
High responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine
干预措施: V520 (Biological)
Stratum 3
Low responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine
干预措施: V520 (Biological)
Stratum 2
Nonresponders who received active vaccine in parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine
干预措施: V520 (Biological)
结局指标
主要结局
Safety and tolerability of ALVAC-HIV or MRKAd5 HIV-1 vaccine in subjects who previously received a 3-dose regimen of Ad5 HIV-1 gag vaccine measured by number of injection-site adverse experiences (AE), non serious systemic AE, lab AE, serious AE.
时间窗: Injection-site AE up to 5 days after vaccination, non-serious systemic AE and Lab AE up to 29 days after vaccination, serious AE for the entire study period (Week 260).
次要结局
- immunogenicity of a single-dose regimen of the ALVAC-HIV vaccine or MRKAd5 HIV-1 vaccine measured by various assays(4 weeks following vaccination)