Supplementation With Zinc and/or Probiotics to Enhance the Immune Response of Oral Rotavirus and Polio Vaccines in Indian Infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 620
- 试验地点
- 2
- 主要终点
- Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine
研究概览
简要总结
Background: Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function.
This study enrolled infants 5 weeks old living in urban Vellore, India to assess the effects of daily zinc (5 mg), probiotic (1010 Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix,GlaxoSmithKline Biologicals) given at 6 and 10 weeks of age. Probiotics and zinc (or placebo) were provided for six weeks. A single dose of test product was administered daily one week prior to first study dose of rotavirus and polio vaccines through 1 week following second study dose of rotavirus and polio vaccines.
详细描述
Co- Primary objectives:
- To evaluate the serologic immune response to rotavirus vaccine (sero-conversion or four-fold rise in rotavirus immunoglobulin A (IgA) antibodies) among Indian infants receiving zinc supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a zinc placebo.
- To evaluate the serologic immune response to rotavirus vaccine (sero-conversion or four-fold rise in rotavirus IgA antibodies) among Indian infants receiving probiotic supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a probiotic placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Weeks 至 16 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants 35-41 days old
- •Live in area under surveillance
- •Current weight ≥3.2 kg
- •No syndromic evidence of immunocompromise as determined by medical doctor
- •No prior illness requiring hospitalization
- •No current medical condition as determined by medical doctor which precludes study involvement
- •Available for follow up for duration of study (through approximately 14 weeks of age)
- •Parents/guardians of infant are able to understand and follow study procedures and agree to participate in the study by providing signed informed consent
排除标准
- •Child has history of atopic symptoms
- •Child has a known digestive system defect
- •Child has history of chronic diarrhea
- •Child has major congenital anomalies
- •Child has received a prior dose of rotavirus vaccine
- •Child has received a prior dose of polio vaccine (beyond the birth dose)
研究组 & 干预措施
Zinc and probiotic
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
干预措施: Oral polio vaccine (Biological)
Zinc alone
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
干预措施: Oral polio vaccine (Biological)
Zinc and probiotic
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
干预措施: Zinc (Dietary Supplement)
Zinc and probiotic
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
干预措施: Probiotic (Dietary Supplement)
Zinc alone
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
干预措施: Probiotic placebo (Dietary Supplement)
Probiotic alone
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
干预措施: Probiotic (Dietary Supplement)
Probiotic alone
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
干预措施: Zinc placebo (Dietary Supplement)
Placebo
Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.
干预措施: Probiotic placebo (Dietary Supplement)
Placebo
Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.
干预措施: Zinc placebo (Dietary Supplement)
Placebo
Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.
干预措施: Oral polio vaccine (Biological)
Probiotic alone
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
干预措施: Oral polio vaccine (Biological)
Placebo
Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.
干预措施: Rotavirus vaccine (Biological)
Zinc alone
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
干预措施: Zinc (Dietary Supplement)
Probiotic alone
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
干预措施: Rotavirus vaccine (Biological)
Zinc and probiotic
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
干预措施: Rotavirus vaccine (Biological)
Zinc alone
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
干预措施: Rotavirus vaccine (Biological)
结局指标
主要结局
Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine
时间窗: from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine
Defined as an increase in serum anti-rotavirus (RV) VP6 IgA antibodies consistent with seroconversion (detection of serum anti-RV VP6 immunoglobulin A (IgA) antibodies at a concentration ≥20 U/ml in a previously seronegative individual) or a fourfold rise in anti-RV VP6 IgA antibodies between baseline and 14 weeks of age. Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus vaccine was administered (14 weeks of age).
Geometric Mean Concentration of Rotavirus-specific IgA
时间窗: from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine
Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus was administered (14 weeks of age). Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus vaccine was administered (14 weeks of age).
次要结局
- Number/Percentage of Subjects With Immune Response to Trivalent Oral Poliovirus Vaccine (OPV)(from first dose of OPV to 4 weeks after last dose of OPV)
- Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 1(0, 4 and/or 7 day post dose 1 of rotavirus vaccine)
- Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 2(0, 4 and/or 7 day post dose 2 of rotavirus vaccine)
- Serious Adverse Events (SAEs)(from first day of study to 4 weeks after last dose)