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

This study has been completed.
Sponsor:
Collaborators:
Christian Medical College, Vellore, India
Ministry of Science and Technology, India
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT01616693
First received: June 6, 2012
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

The percentage of participants with a serologic immune response (seroconversion or four-fold rise in rotavirus IgA antibodies) to rotavirus vaccine at 14 weeks of age among infants receiving zinc or probiotic supplements will be at least 15% higher and significantly better to that of infants who receive a placebo for zinc or probiotic supplement.


Condition Intervention Phase
Immunity to Oral Rotavirus Vaccine
Immunity to Oral Polio Vaccine
Shedding of Oral Rotavirus Vaccine
Biological: Rotavirus vaccine (Rotarix), oral polio vaccine (Bio-polio), zinc supplement and probiotic supplement (Culturelle)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Supplementation With Zinc and/or Probiotics to Enhance the Immune Response of Oral Rotavirus and Polio Vaccines in Indian Infants

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • Change in Rotavirus IgA immune response [ Time Frame: Baseline and 4 weeks post rotavirus vaccine dose 2 ] [ Designated as safety issue: No ]
    A serologic immune response to rotavirus vaccine will be defined as an increase in serum anti-rotavirus (RV) VP6 IgA antibodies consistent with seroconversion (detection of serum anti-RV VP6 IgA antibodies at a concentration ≥20 U/ml in a previously seronegative individual) or a fourfold rise in anti-RV VP6 IgA antibodies between baseline and 14 weeks of age.


Secondary Outcome Measures:
  • Change in Polio neutralizing antibody titer immune response [ Time Frame: Baseline and 4 weeks post OPV dose 2 ] [ Designated as safety issue: No ]
    A serologic immune response to oral polio vaccine will be defined as a neutralizing antibody titer to polio virus subtype 3 greater than or equal to 1:8 at 14 weeks of age. This antigen will be used because it is conservative in that it gives the lowest immune response of all three polio antigens.

  • Change in Rotavirus IgA immune response (GMTs) [ Time Frame: Baseline and 4 weeks post rotavirus vaccine dose 2 ] [ Designated as safety issue: No ]
    Geometric mean titers (GMTs) of serum anti-rotavirus VP6 IgA antibody

  • Serious adverse events (SAEs) [ Time Frame: Day 0, vaccine dose 1 to 4 weeks post vaccine dose 2 ] [ Designated as safety issue: Yes ]
    Serious adverse events (SAEs) and solicited adverse events (AEs) will be monitored.

  • Rotavirus vaccine shedding [ Time Frame: 0, 4 and/or 7 day post dose 1 and dose 2 rotavirus vaccine ] [ Designated as safety issue: No ]
    Shedding of rotavirus following vaccination through detection of rotavirus antigen by ELISA and confirmed as vaccine type by RT-PCR.


Enrollment: 620
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zinc and probiotic
Receives both zinc and probiotic supplements along with rotavirus and oral polio vaccines
Biological: Rotavirus vaccine (Rotarix), oral polio vaccine (Bio-polio), zinc supplement and probiotic supplement (Culturelle)

Oral rotavirus vaccine (Rotarix). 2 doses (1 ml) at 6 and 10 weeks of age.

Oral polio vaccine (Bio-polio). 3 doses (0.1 ml) at 6, 10 and 14 weeks of age.

Oral zinc sulphate syrup or placebo (1mg/ml; 5ml), given weekly starting 1 week pre-rotavirus vaccine dose 1 through 1 week post rotavirus vaccine dose 2.

Oral probiotic, Lactobacillus rhamnosus (Culturelle) or placebo (lx10^9; 20ml), given weekly starting 1 week pre-rotavirus vaccine dose 1 through 1 week post rotavirus vaccine dose 2.

Active Comparator: Zinc and probiotic placebo supplements
Receives zinc and probiotic placebo supplements along with rotavirus and oral polio vaccines
Biological: Rotavirus vaccine (Rotarix), oral polio vaccine (Bio-polio), zinc supplement and probiotic supplement (Culturelle)

Oral rotavirus vaccine (Rotarix). 2 doses (1 ml) at 6 and 10 weeks of age.

Oral polio vaccine (Bio-polio). 3 doses (0.1 ml) at 6, 10 and 14 weeks of age.

Oral zinc sulphate syrup or placebo (1mg/ml; 5ml), given weekly starting 1 week pre-rotavirus vaccine dose 1 through 1 week post rotavirus vaccine dose 2.

Oral probiotic, Lactobacillus rhamnosus (Culturelle) or placebo (lx10^9; 20ml), given weekly starting 1 week pre-rotavirus vaccine dose 1 through 1 week post rotavirus vaccine dose 2.

Active Comparator: Zinc placebo and probiotic supplements
Receives zinc placebo and probiotic supplements along with rotavirus and oral polio vaccines
Biological: Rotavirus vaccine (Rotarix), oral polio vaccine (Bio-polio), zinc supplement and probiotic supplement (Culturelle)

Oral rotavirus vaccine (Rotarix). 2 doses (1 ml) at 6 and 10 weeks of age.

Oral polio vaccine (Bio-polio). 3 doses (0.1 ml) at 6, 10 and 14 weeks of age.

Oral zinc sulphate syrup or placebo (1mg/ml; 5ml), given weekly starting 1 week pre-rotavirus vaccine dose 1 through 1 week post rotavirus vaccine dose 2.

Oral probiotic, Lactobacillus rhamnosus (Culturelle) or placebo (lx10^9; 20ml), given weekly starting 1 week pre-rotavirus vaccine dose 1 through 1 week post rotavirus vaccine dose 2.

Placebo Comparator: Zinc placebo and probiotic placebo
Receives zinc placebo and probiotic placebo along with rotavirus and oral polio vaccines
Biological: Rotavirus vaccine (Rotarix), oral polio vaccine (Bio-polio), zinc supplement and probiotic supplement (Culturelle)

Oral rotavirus vaccine (Rotarix). 2 doses (1 ml) at 6 and 10 weeks of age.

Oral polio vaccine (Bio-polio). 3 doses (0.1 ml) at 6, 10 and 14 weeks of age.

Oral zinc sulphate syrup or placebo (1mg/ml; 5ml), given weekly starting 1 week pre-rotavirus vaccine dose 1 through 1 week post rotavirus vaccine dose 2.

Oral probiotic, Lactobacillus rhamnosus (Culturelle) or placebo (lx10^9; 20ml), given weekly starting 1 week pre-rotavirus vaccine dose 1 through 1 week post rotavirus vaccine dose 2.


  Eligibility

Ages Eligible for Study:   5 Weeks to 16 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616693

Locations
India
Christian Medical Center, Vellore
Vellore, Tamil Nadu, India, 632 004
Sponsors and Collaborators
PATH
Christian Medical College, Vellore, India
Ministry of Science and Technology, India
Investigators
Principal Investigator: Gagandeep Kang, MD, PhD, FRCPath, FAAM, FASc Christian Medical Center, Vellore, India
  More Information

No publications provided

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01616693     History of Changes
Other Study ID Numbers: CMC ZP 2012; PATH HS-658
Study First Received: June 6, 2012
Last Updated: August 28, 2013
Health Authority: India: Christian Med College & Hosp IRB #1
United States: Western Institutional Review Board
United States: Centers for Disease Control and Prevention Institutional Review Board

Keywords provided by PATH:
rotavirus
polio
zinc supplement
probiotic supplement
rotavirus vaccine shedding

Additional relevant MeSH terms:
Poliomyelitis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014