Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
Condition: Immunity to Oral Rotavirus Vaccine; Immunity to Oral Polio Vaccine; Shedding of Oral Rotavirus Vaccine
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Probiotic; Zinc; Probiotic placebo; Zinc placebo; Rotavirus vaccine; Oral polio vaccine
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Biological; Biological
Intervention description(s): A capsule that contains at least 1 x 10^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.; Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.; The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no Lactobacillus rhamnosus GG. The contents of the capsule were given once daily orally.; The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.; 1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.; A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
Other intervention name(s): Culturelle; Rotarix®; Biopolio®
Intervention MeSH terms: Zinc; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: rotavirus; polio; zinc supplement; probiotic supplement; rotavirus vaccine shedding