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

PATH

Status and phase: Completed; Phase 4

Conditions: Shedding of Oral Rotavirus Vaccine; Immunity to Oral Rotavirus Vaccine; Immunity to Oral Polio Vaccine

Treatments: Biological: Oral polio vaccine; Dietary Supplement: Probiotic placebo; Biological: Rotavirus vaccine; Dietary Supplement: Probiotic; Dietary Supplement: Zinc placebo; Dietary Supplement: Zinc

Study type: Interventional

Funder types: Other

Identifiers

NCT01616693

CMC ZP 2012 PATH HS-658;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 620 patients

Sex: All

Ages: 5 to 16 weeks old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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620 participants in 4 patient groups, including a placebo group

Zinc and probiotic

Experimental group

Description:

Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.

Treatment:

Dietary Supplement: Probiotic

Biological: Rotavirus vaccine

Biological: Oral polio vaccine

Dietary Supplement: Zinc

Zinc alone

Active Comparator group

Description:

Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.

Treatment:

Dietary Supplement: Probiotic placebo

Biological: Rotavirus vaccine

Biological: Oral polio vaccine

Dietary Supplement: Zinc

Probiotic alone

Active Comparator group

Description:

Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.

Treatment:

Dietary Supplement: Probiotic

Biological: Rotavirus vaccine

Dietary Supplement: Zinc placebo

Biological: Oral polio vaccine

Placebo

Placebo Comparator group

Description:

Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.

Treatment:

Dietary Supplement: Probiotic placebo

Biological: Rotavirus vaccine

Dietary Supplement: Zinc placebo

Biological: Oral polio vaccine