Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
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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 |
- 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.
- 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.
| Estimated Enrollment: | 560 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated 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 |
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| Contact: Gagandeep Kang, MD, PhD, FRCPath, FAAM, FASc | +91-416-228-2052 | gkang@cmcvellore.ac.in |
| Contact: Jacob John, MD | +91-416-228-4207 | jacob@cmcsph.org |
| India | |
| Christian Medical Center, Vellore | Recruiting |
| Vellore, Tamil Nadu, India, 632 004 | |
| Principal Investigator: Gagandeep Kang, MD, PhD, FRCPath, FAAM, FASc | |
| Principal Investigator: | Gagandeep Kang, MD, PhD, FRCPath, FAAM, FASc | Christian Medical Center, Vellore, India |
More Information
No publications provided
| Responsible Party: | Program for Appropriate Technology in Health |
| 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: | July 25, 2012 |
| 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 Program for Appropriate Technology in Health:
|
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 May 19, 2013