Immunogenicity of Inactivated Polio Vaccine in Puerto Rico; A Comparative Cohort Study of Two Vaccination Schedules
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 473
- 试验地点
- 1
- 主要终点
- Serum collection and antibody titers
研究概览
简要总结
As poliovirus eradication progresses rapidly, strategies to discontinue oral poliovirus vaccination need to be established. One strategy would be to use inactivated poliovirus vaccine (IPV) transitionally, and this has already occurred in the United States. It is not clear, however, if 3 doses of IPV provide sufficient immunogenicity when administered according to World Health Organization (WHO)/Expanded Programme on Immunization (EPI) schedule in a tropical, developing area where no wild-poliovirus circulates.
Puerto Rico will be the study site for this randomized clinical trial. Healthy infants will be identified at birth in a hospital-system, enrolled within 4 weeks of birth, and randomized into one of two arms: United States of America (U.S.A.) schedule (8, 16, 24 weeks/2, 4, 6 months) or WHO schedule (6, 10, 14 weeks). Both groups will receive IPV at visits 1, 2 and 3. Infants will receive all age-appropriate EPI childhood vaccinations along with IPV, to decrease confusion and inconvenience to the parent. Serum will be collected twice, at visit 1 and visit 4 (30-45 days after IPV-3), to measure antibody titers. Sera will be measured for neutralizing antibodies at the Centers for Disease Control (CDC). Based on the lowest seroconversion rate estimate of 85%, and to have a probability of .80 that the estimate from this study is in error by no more than 10%, the investigators will need to enroll 220 infants in each arm. To compensate for attrition and retain statistical power, the investigators plan to enroll up to 250 infants in each arm. This study is expected to require at least 20 months to complete. Results will provide valuable and timely information applicable to global polio eradication efforts. Any participant found not to be protected after 3 doses of IPV will be given a booster at 9-12 months. Results will provide valuable and timely information applicable to global polio eradication efforts.
详细描述
The proposed study will be a prospective, randomized clinical trial of the immunogenicity of IPV among two groups of infants using different immunization schedules (WHO/EPI and US).
Study will begin with an enrollment period up to 10 months. All infants born at San Lucas Hospital will be eligible unless otherwise excluded. The study will continue until 10 months after the last infant is enrolled. There will be four or five study visits, depending on the cohort.
Study Population:
Infants will be identified at birth at San Lucas Hospital; all babies born during the enrollment period at the selected hospital will be considered eligible. Mothers will be approached in the hospital by the study -nurse after infant's birth and be informed about the study. Inclusion and exclusion criteria will be assessed at this time and if the mother agrees to the study, informed consent will be obtained.
Randomization will be based on what day the baby was born. Even days will be assigned to the WHO schedule and odd days to the US schedule. The mother will be told which cohort the infant is in and given an immunization card with dates that the infant is to return to receive vaccinations. The card will also include study contact phone numbers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Hour 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants under 48 hours of age born at San Lucas Hospital during study enrollment period
- •Infants with gestational age of > 37 weeks as assessed by neonatologist
- •Mother/guardian gives informed consent
- •Infant is expected to reside in Puerto Rico for the following 8 months
排除标准
- •Mother/guardian does not speak English or Spanish
- •Mother/guardian has religious/philosophical objection to immunizations
- •Infant has serious chronic or acute health problems that require hospitalization immediately (within 1 day) after birth (assessed by infant not being placed in San Lucas Hospital well-baby clinic)
- •Mother expects to travel with infant during study period to a country known to have circulating poliovirus or that uses oral poliovirus vaccine (OPV)
结局指标
主要结局
Serum collection and antibody titers
时间窗: 30-45 days after vaccination
Serum will be collected twice, at visit 1 and visit 4 (30-45 days after IPV-3), to measure antibody titers.
次要结局
- Adverse Events(7 days after vaccination)