Clinical trial NCT01616693: Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
Official title: Supplementation With Zinc and/or Probiotics to Enhance the Immune Response of Oral Rotavirus and Polio Vaccines in Indian Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Immunity to Oral Rotavirus Vaccine
Immunity to Oral Polio Vaccine
Shedding of Oral Rotavirus Vaccine
Keywords: rotavirus
polio
zinc supplement
probiotic supplement
rotavirus vaccine shedding
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Christian Medical College, Vellore, India
name: Ministry of Science and Technology, India
First posted: 2012-06-12
Enrollment: 620
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: Co- Primary objectives:

1. 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.
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine
timeFrame: from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine
measure: Geometric Mean Concentration of Rotavirus-specific IgA
timeFrame: from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine
Secondary outcomes:
measure: Number/Percentage of Subjects With Immune Response to Trivalent Oral Poliovirus Vaccine (OPV)
timeFrame: from first dose of OPV to 4 weeks after last dose of OPV
measure: Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 1
timeFrame: 0, 4 and/or 7 day post dose 1 of rotavirus vaccine
measure: Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 2
timeFrame: 0, 4 and/or 7 day post dose 2 of rotavirus vaccine
measure: Serious Adverse Events (SAEs)
timeFrame: from first day of study to 4 weeks after last dose
Other outcomes:
Locations:
city: Vellore
country: India
facility: Christian Medical Center, Vellore
state: Tamil Nadu
Study officials:
affiliation: Christian Medical Center, Vellore, India
name: Gagandeep Kang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: