A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 46
- 主要终点
- Comparison of measles seroconversion rates at 13 months of age between HIV-infected children vaccinated at 12 months of age and HIV-infected children vaccinated at 6 and 12 months of age
研究概览
简要总结
To compare measles seroconversion rates (development of antibodies) at 13 months of age in HIV-infected and uninfected children on one of two immunization schedules: attenuated measles/mumps/rubella virus (M-M-R II) vaccine at 12 months versus attenuated measles vaccine (Attenuvax) at 6 months plus M-M-R II vaccine at 12 months.
Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates. Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection. This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected children's humoral immune system.
详细描述
Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates. Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection. This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected children's humoral immune system.
Patients, HIV infected and uninfected, are randomized to one of two attenuated measles vaccine schedules: at 6 and 12 months of age, or at 12 months of age only. Attenuvax is administered as the month 6 vaccine and M-M-R II as the month 12 vaccine. Patients are followed for 24 months after the last vaccination.
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
- None
入排标准
- 年龄范围
- 6 Months 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must have:
- •Willing to have and receive results of HIV test
- •Been born to mothers with HIV infection or history of AIDS-defining condition by CDC criteria.
- •No history of opportunistic infection.
- •No known exposure to measles within 14 days prior to study entry.
- •CD4+ lymphocyte count >= 750 cells/mm3 or more than 15% at 6 months of age.
- •Parent or legal guardian available to give written informed consent and be willing to comply with all study requirements.
- •Childhood immunizations (other than measles) according to current recommendations of the Immunization Practice Advisory Committee and American Academy of Pediatrics.
- •Coenrollment on other therapeutic protocols (except for ACTG 185) is permitted.
- •Patients must be located in a geographical area where measles immunization at 12 months is standard of care.
- •Recommended:
- •Childhood immunizations other than measles according to current guidelines.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Intercurrent illness and/or fever for 7 days.
- •Known sensitivity or allergy to neomycin or eggs.
- •Concurrent Medication:
- •Uninterrupted or anticipated steroid therapy (>= 2 mg/kg/day) for more than 2 weeks duration.
- •Patients with the prior condition are excluded:
- •Platelet count < 50,000/mm3 at any time prior to study entry.
- •Prior Medication:
- •Any IgG preparation within the past 6 months.
研究组 & 干预措施
1
Participants who receive vaccination at 6 and 12 months of age
干预措施: Attenuvax (Biological)
1
Participants who receive vaccination at 6 and 12 months of age
干预措施: M-M-R-II (Biological)
2
Participants who receive vaccination only at 12 months of age
干预措施: M-M-R-II (Biological)
结局指标
主要结局
Comparison of measles seroconversion rates at 13 months of age between HIV-infected children vaccinated at 12 months of age and HIV-infected children vaccinated at 6 and 12 months of age
时间窗: Throughout study
Comparison of seroconversion rates at 13 months of age (following second vaccination) of HIV-uninfected children with HIV-infected children.
时间窗: Throughout study
Comparison of seroconversion rates at 13 months of age (following single vaccination) of HIV-uninfected children with HIV-infected children following vaccination at 12 months of age
时间窗: Throughout study
次要结局
- Evaluation of adverse effects and immune reactions to vaccine in HIV-infected children and HIV-uninfected vaccinees(Throughout study)
- Comparison of measles seroconversion rates in HIV-infected children vaccinated at 6 months of age with HIV-infected children vaccinated at 12 months of age(Throughout study)
- Assessment of measles antibody decay and persistence in HIV-infected and HIV-unifected vaccinees(Throughout study)