A DOUBLE-BLIND, RANDOMIZED, CONTROLLED PHASE III STUDY TO ASSESS THE PROPHYLACT

评估预防措施的双盲、随机、对照 III 期研究

• 批准号: 7606167
• 负责人: Joel I. Ward
• 金额: $ 3.42万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606167
• 关键词: Age-Years; Blood Cells; Blood specimen; Cellular Immunity; Communities; Computer Retrieval of Information on Scientific Projects Database; Counseling; Dose; Double-Blind Method; Enrollment; Funding; Grant; Hepatitis A; Hepatitis A Vaccines; Herpesvirus 1; Human Herpesvirus 2; Institution; Participant; Phase; Phase III Clinical Trials; Prevention; Purpose; Randomized; Recording of previous events; Recruitment Activity; Research; Research Personnel; Resources; Safe Sex; Screening procedure; Serologic tests; Simplexvirus; Source; Study of serum; Symptoms; Testing; United States National Institutes of Health; Vaccines; Virus Shedding; Visit; Western Blotting; Woman; aluminum sulfate; college; efficacy trial; follow-up; genital herpes; prevent

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this multicenter, Phase III study is to evaluate the efficacy of a herpes vaccine (manufactured by GlaxoSmithKline Biologicals) in the prevention of genital herpes. This vaccine has been evaluated in 2 prior Phase III efficacy trials where the vaccine was found to be generally safe and effective in preventing genital herpes in women who had no prior history of herpes types 1 or 2 (HSV-1 or HSV-2). For this study, healthy women 18 to 30 years of age will be recruited from the community and from local college campuses. The UCLA CVR will oversee enrollment of 400 women: 150 at Harbor-UCLA, 150 at CSULB and 100 at CSUDH. At the screening visit, women will be tested for HSV by Western Blot, and may be eligible for enrollment if they are negative for HSV-1 and HSV-2, and if they are available for follow-up for a 20 month period. Study participants will be randomly assigned to receive 3 doses of the gD-Alum/MPL herpes vaccine or 3 doses of the hepatitis A (Havrix) vaccine at 0, 1 month and 6 months. At each study visit, they will be counseled about safe sex and means for preventing herpes. Blood samples will be obtained at 0, 2, 6, 7, 12, 16 and 20 months and tested for herpes. In addition, blood for cell mediated immunity (CMI) will be obtained at 2 and 7 months. Study participants who develop signs and/or symptoms of herpes during the 20 month follow-up period will be evaluated and a culture obtained. Participants who are found to be positive for herpes through serology or culture will be asked to take part in a herpes viral shedding sub-study. At the conclusion of the study, if the herpes vaccine is found to be effective, it will be offered to study participants who receive the hepatitis A vaccine.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这项多中心 III 期研究的目的是评估疱疹疫苗（由葛兰素史克生物制品公司制造）预防生殖器疱疹的功效。该疫苗已在先前的 2 项 III 期疗效试验中进行了评估，结果发现该疫苗对于既往无 1 型或 2 型疱疹（HSV-1 或 HSV-2）病史的女性预防生殖器疱疹通常是安全有效的。本研究将从社区和当地大学校园招募 18 至 30 岁的健康女性。 UCLA CVR 将监督 400 名女性的入学情况：Harbor-UCLA 150 名，CSULB 150 名，CSUDH 100 名。在筛选访视时，女性将通过蛋白质印迹法进行 HSV 检测，如果 HSV-1 和 HSV-2 呈阴性，并且可以进行 20 个月的随访，则可能有资格参加。研究参与者将被随机分配在第 0、1 个月和 6 个月时接受 3 剂 gD-Alum/MPL 疱疹疫苗或 3 剂甲型肝炎 (Havrix) 疫苗。每次研究访问时，他们都会接受有关安全性行为和预防疱疹方法的咨询。将在 0、2、6、7、12、16 和 20 个月时采集血样并进行疱疹检测。此外，将在 2 个月和 7 个月时获取用于细胞介导免疫 (CMI) 的血液。在 20 个月的随访期间出现疱疹体征和/或症状的研究参与者将接受评估并获得培养物。通过血清学或培养发现疱疹呈阳性的参与者将被要求参加疱疹病毒脱落子研究。研究结束时，如果发现疱疹疫苗有效，将提供给接受甲型肝炎疫苗的研究参与者。