A Double-blind, Randomized Controlled Trial of the Effect of Vaccine Inoculum on Oral Rotavirus Vaccine (Rotarix, GlaxoSmithKline) Take and Immunogenicity in Dhaka, Bangladesh
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Number (or Percentage) of Infants in Each Study Arm With Rotavirus-specific Plasma Immunoglobulin A (IgA) Seroconversion Post-vaccination
研究概览
简要总结
Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines work remarkably well in high-income countries, but for unclear reasons they underperform in low-income countries. A double-blind, randomized control trial will be performed to evaluate whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can improve immune responses among infants in Dhaka, Bangladesh.
Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6 and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum rotavirus-specific IgA responses to determine vaccine immunogenicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 15 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy infant (as determined by medical officers)
- •Age 0-7 days at enrolment
- •Mother willing and able to provide signed informed consent
- •Mother willing to allow infant to be vaccinated according to study schedule
- •Mother willing to allow biological specimens, including blood, stool, and saliva, to be collected from infant according to study protocol
- •Mother willing and able to adhere to study schedule
排除标准
- •Obvious congenital malformation
- •Birth weight (if known) or enrolment weight (if birth weight unknown) < 2000 gm
- •Known immunocompromising condition in infant
- •Enrolment in other vaccine research trials
- •Other household member enrolled in this study
研究组 & 干预措施
Rotarix, single dose
Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life
干预措施: Rotarix, dose 1 (Biological)
Rotarix, single dose
Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life
干预措施: Placebo (for Rotarix dose 2) (Drug)
Rotarix, double dose
Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life
干预措施: Rotarix, dose 1 (Biological)
Rotarix, double dose
Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life
干预措施: Rotarix, dose 2 (Biological)
结局指标
主要结局
Number (or Percentage) of Infants in Each Study Arm With Rotavirus-specific Plasma Immunoglobulin A (IgA) Seroconversion Post-vaccination
时间窗: Measured at week 14 of life
This outcome will measure seroconversion, i.e. the change in plasma rotavirus-specific IgA concentration at week 14 of life compared to week 6 of life (baseline). Blood will be collected from infants prior to the first dose of Rotarix at week 6 of life and again at week 14 of life (4 weeks following the second dose) for measurement of plasma rotavirus-specific IgA by enzyme immunoassay. Infants will be assessed for seroconversion (IgA concentration \<=20 U/mL pre-vaccination and \>20 post-vaccination). Infants who demonstrate rotavirus-specific IgA seroconversion will be categorized as having met the outcome measure.
Number (or Percentage) of Infants in Each Study Arm With Successful Vaccine Take, Defined as Positive Fecal Vaccine Shedding Post-vaccination OR Rotavirus-specific Plasma IgA Seroconversion Post-vaccination
时间窗: Measured at week 14 of life
Vaccine take is an aggregate, dichotomous immunogenicity measure (successful vaccine take vs no vaccine take). Infants positive for either fecal vaccine shedding OR plasma rotavirus-specific IgA seroconversion (as described in Outcomes 1 and 2, respectively) will be categorized as having met the outcome measure of successful vaccine take. Those who met neither outcome will be categorized as no vaccine take.
Number (or Percentage) of Infants in Each Study Arm Who Test Positive for Fecal Rotavirus Vaccine-strain Virus Shedding Post-vaccination
时间窗: Measured through week 12 of life
This will be an aggregate measure demonstrating a change from baseline. Infants will have stool collected immediately prior to Rotarix vaccination at weeks 6 and 10 of life, then 4, 7, and 14 days following each dose (i.e. last assessment at week 12 of life). Each specimen will be assessed for vaccine-strain virus (i.e. fecal vaccine shedding) at each time point by polymerase chain reaction. Any child who has a change in fecal vaccine shedding status, from negative at baseline (6 weeks) to positive at any subsequent time point, will be categorized as having met the outcome measure for positive fecal vaccine shedding.
次要结局
未报告次要终点
研究者
Benjamin Lee
Assistant Professor, Department of Pediatrics
University of Vermont