A Simulated Vaccine Efficacy Trial Using MMR and Tdap-IPV Vaccines in Healthy, HIV Negative Women at High Risk of HIV Infection in Lusaka and Ndola, Zambia.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Number of participants who receive 1 Vaccine
研究概览
简要总结
Participants will receive vaccination for measles, mumps, and rubella (MMR) and tetanus, diphtheria, pertussis, and inactivated polio (Tdap-IPV). The study schedule design is to simulate a vaccine efficacy trial to see if single women can participate in studies that mimic actual HIV vaccine studies.
详细描述
This study will evaluate if women at high risk for HIV infection residing in Lusaka, Zambia and Ndola, Zambia are willing to participate and can be retained in future HIV vaccine trials. 150 women will be enrolled that are either sex workers or single women that were identified at infant vaccination clinics (at risk due to a recent pregnancy indicating unprotected sexual contact outside of marriage or cohabitation). Two licensed vaccines will be administered as proxies for HIV vaccine administration. The clinic and laboratory procedures will simulate HIV vaccine trial procedures and will therefore inform recruitment and retention strategies and HIV incidence among high risk women in future HIV vaccine trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At high risk of HIV, defined by occupation (female sex workers) or recent delivery (single mothers)
- •Planning to stay in Lusaka or Ndola for at least 12 months
- •Willing to undergo HIV testing, counseling and receive HIV test results Able and willing to provide adequate locator information for tracking purposes, and willing to be contacted by the study staff
- •Willing and able to provide adequate locator information and willing to be contacted by phone if available or home visit by study staff.
- •Willing to answer questions on HIV risk factors, and if infected, questions related to the route and timing of exposure
- •Willing and able to return for follow-up visits
- •Willing and able to provide informed consent
- •Willing to undergo pregnancy testing and use an injectable, implant or intrauterine device (IUD) from screening until four months after the last vaccination during the study
排除标准
- •HIV-1/2 infection
- •Pregnant or intending to become pregnant during the study
- •History of severe allergic reaction to any substance including eggs, gelatin, and neomycin
- •Any clinically significant acute illness or chronic medical condition that is considered progressive, or in the opinion of the investigator, makes the volunteer unsuitable for participation in the study
- •Immunosuppressive therapy
- •Women who opt out of HIV counseling and testing services provided by the clinic
- •Women who have any condition that in the opinion of the Investigator or designee, would preclude provision of informed consent, or otherwise interfere with achieving the study objectives
- •Participation in another clinical trial unless approved by the Principal Investigator and the International AIDS Vaccine Initiative (IAVI)
- •Recent receipt of an investigational blood product or vaccine
- •Failure of assessment of understanding
研究组 & 干预措施
Tdap-IPV/MMR
Participants receiving Tdap-IPV vaccine (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) at 0 months/at enrollment, followed by MMR vaccine (Measles, mumps, and rubella) at 3 months.
干预措施: MMR Vaccine (Biological)
MMR/Tdap-IPV
Participants receiving MMR vaccine (Measles, mumps, and rubella) at 0 months/at enrollment, followed by Tdap-IPV vaccine (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) at 3 months.
干预措施: Tdap - IPV Vaccine (Biological)
Tdap-IPV/MMR
Participants receiving Tdap-IPV vaccine (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) at 0 months/at enrollment, followed by MMR vaccine (Measles, mumps, and rubella) at 3 months.
干预措施: Tdap - IPV Vaccine (Biological)
MMR/Tdap-IPV
Participants receiving MMR vaccine (Measles, mumps, and rubella) at 0 months/at enrollment, followed by Tdap-IPV vaccine (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) at 3 months.
干预措施: MMR Vaccine (Biological)
结局指标
主要结局
Number of participants who receive 1 Vaccine
时间窗: 12 Months from Baseline
The number of participants who receive at least 1 of the vaccines at the end of the study will be recorded by the study staff.
Number of protocol violations
时间窗: 12 Months from Baseline
The number of protocol violations that occur in the course of the study will be recorded.
Number of Corrective Action Plans
时间窗: 12 Months from Baseline
The total number of Corrective and Preventative Action Plans implemented in the course of the study to address protocol deviations will be recorded.
Time to Achieve Target Enrollment
时间窗: 12 Months from Baseline
The total time from the enrollment of first participant until enrollment of last participant will be recorded.
Number of participants retained
时间窗: 12 Months from Baseline
The number of participants who complete the study versus the number of participants enrolled will be calculated at the end of the study.
Number of participants who receive both vaccines
时间窗: 12 Months from Baseline
The number of participants who receive both vaccines at the end of the study will be recorded by the study staff.
Ratio of Female Sex Workers vs Single Mothers who adhere to study procedures
时间窗: 12 Months from Baseline
The number of female sex workers and single mothers who adhere to all study procedures will be recorded and the ratio calculated.
次要结局
未报告次要终点