Immunity to Oral Polio Vaccine Clinical Trial
Official title:
Supplementation With Zinc and/or Probiotics to Enhance the Immune Response of Oral Rotavirus and Polio Vaccines in Indian Infants
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.
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.
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