NCT01616693

Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines

Supplementation With Zinc and/or Probiotics to Enhance the Immune Response of Oral Rotavirus and Polio Vaccines in Indian Infants

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 620 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 5 Weeks – 16 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Immunity to Oral Rotavirus Vaccine
• Immunity to Oral Polio Vaccine
• Shedding of Oral Rotavirus Vaccine

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	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.
DIETARY_SUPPLEMENT	Zinc	Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
DIETARY_SUPPLEMENT	Probiotic placebo	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.
DIETARY_SUPPLEMENT	Zinc placebo	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.
BIOLOGICAL	Rotavirus vaccine	1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
BIOLOGICAL	Oral polio vaccine	A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-06-12
• Last updated: 2018-12-26
• Results posted: 2018-11-30

Locations

1 site across 1 country: India