Seroprevalence of Antibodies to Measles, Mumps, and Rubella, and Serologic Responses After Vaccination Among Human Immunodeficiency Virus (HIV)-1 Infected Adults in Northern Thailand
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 632
- 试验地点
- 1
- 主要终点
- Proportion of participants with protective antibodies to measles, mumps, and rubella
研究概览
简要总结
This is a prevalence study of protective antibodies to measles, mumps, and rubella (MMR) in HIV-infected adults and HIV-uninfected controls. MMR vaccination were provided to both groups who had no protective antibodies to at least one of the three viruses.
详细描述
From July to August 2011, 500 HIV-infected and 132 HIV-uninfected participants those met the eligibility criteria were enrolled and tested for protective antibodies to measles, mumps, and rubella.
All participants who had no protective antibody to at least one of the three viruses were recruited to vaccinate for MMR vaccine. Between June to September 2012, 249 HIV-infected and 46 HIV-uninfected adults were vaccinated. Antibodies to MMR were measured at week 8-12, and week 48 after vaccination, which were completed in August 2013. The results were ready for analysis in March 2014.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For HIV-infected participants, inclusions criteria were
- •20-59 years old, ability to provide informed consent
- •receiving cART
- •CD4 cell count ≥200 cell/mm3 within 6 months before enrollment
- •plasma HIV-1 RNA <50 copies/mL, and 5) ability to provide informed consent.
排除标准
- •For both groups
- •pregnancy or lactating
- •receiving cancer treatment, organ transplantation, ≥0.5 mg/kg/day of prednisolone or equivalent, or immunomodulating treatment
- •impaired renal function (creatinine clearance <30 mL/min)
- •impaired liver function as defined by Child-Pugh C.
研究组 & 干预措施
HIV-infected adults
Two-hundreds and forty-nine HIV-infected participants received a single dose of MMR vaccine (GlaxoSmithKline Biologicals) at deltoid region.
Interventions were a single dose of 0.5 ml of MMR vaccine. Each 0.5 ml of vaccine contained at least 1000 TCID50 of Schwarz measles strain, at least 1000 TCID50 of RIT 4385 mumps, and at least 1000 TCID50 of Wistar RA 27/3 rubella strains.
干预措施: 0.5 ml of MMR vaccine (Biological)
HIV-uninfected adults
Forty-six HIV-uninfected participants received a single dose of MMR vaccine (GlaxoSmithKline Biologic) at deltoid region.
Interventions were a single dose of 0.5 ml of MMR vaccine. Each 0.5 ml of vaccine contained at least 1000 TCID50 of Schwarz measles strain, at least 1000 TCID50 of RIT 4385 mumps, and at least 1000 TCID50 of Wistar RA 27/3 rubella strains.
干预措施: 0.5 ml of MMR vaccine (Biological)
结局指标
主要结局
Proportion of participants with protective antibodies to measles, mumps, and rubella
时间窗: Baseline
Comparison of proportions of participants who had protective antibodies to measles between HIV-infected participants and HIV-uninfected participants
次要结局
- The geometric means of anti-rubella IgG level(48 weeks after a single dose of MMR vaccination)
- Proportion of participants with protective antibodies to measles, mumps, and rubella(48 weeks after a single dose of MMR vaccination)
- The geometric means of anti-measles IgG level(48 weeks after a single dose of MMR vaccination)
- The geometric means of anti-mumps IgG titers(48 weeks after a single dose of MMR vaccination)
- Proportion of participants who had adverse effects from vaccination(72 hours after MMR vaccination)
- Proportion of participants with protective antibodies to measles, mumps, and rubella(8-12 weeks after a single dose of MMR vaccination)
- The geometric means of anti-measles IgG level(8-12 weeks after a single dose of MMR vaccination)
- The geometric means of anti-mumps IgG titers(8-12 weeks after a single dose of MMR vaccination)
- The geometric means of anti-rubella IgG level(8-12 weeks after a single dose of MMR vaccination)
研究者
Romanee Chaiwarith
Associate Professor
Chiang Mai University