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

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Christian Medical College, Vellore, India

  collaborator OTHER

• Ministry of Science and Technology, India

  collaborator OTHER_GOV

• PATH

  lead OTHER

Principal Investigators

• Gagandeep Kang, MD, PhD · Christian Medical Center, Vellore, India

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

5 Weeks

Max Age

16 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2013-07-31

Completion

2013-07-31

Countries

• India

Study Locations