Phase 3
N=700
Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh
Rotavirus Diarrhea · Vaccine Virus Shedding · Tropical Enteropathy
Bottom Line
View on ClinicalTrials.gov: NCT01375647 ↗Enrolled (actual)
700
Serious AEs
10.4%
Results posted
Apr 2025
Primary outcome: Primary: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) — 99; 109 Participants — p=0.4
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IPV (inactivated polio vaccine) (Biological); Rotarix (Biological)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Vermont
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) |
99; 109 | 0.4 |
| PRIMARY Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial) |
67; 114 | 0.00004 sig |
| SECONDARY Duration of Fecal Shedding of Polio Vaccine Virus, Each Sabin Type (Polio Trial) |
17.9; 18.5; 18.4; 19.6; 17.7; 16.4 | 0.5 |
| SECONDARY Community Fecal Shedding of Polio Vaccine Virus Just Prior to Oral Polio Vaccine Dose at 52 Weeks (Polio Trial) |
— | — |
| SECONDARY Presence of Fecal Polio Virus Shedding Within the Three Sabin Strains (Polio Trial) |
67; 72; 22; 33; 40; 35 | — |
| SECONDARY Serum Neutralizing Antibody Response (Polio Trial) |
9; 79; 9; 62; 13; 110 | — |
| SECONDARY Total Number of Diarrheal Episodes (Rotavirus Trial) |
3; 3 | 0.981 |
| SECONDARY Total Duration of Rotavirus-associated Diarrheal Episodes (Rotavirus Trial) |
0; 0 | <0.0001 sig |
Summary
Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breastmilk antibodies, changes in gut microbiota, and genetic susceptibility.
Primary Objective: to determine whether tropical enteropathy impairs the efficacy of oral polio and rotavirus vaccines in children in Bangladesh.
Secondary Objectives: 1) to determine the impact of an IPV (inactivated polio vaccine) boost on the efficacy of OPV (oral polio vaccine) and 2) to determine the efficacy of Rotarix oral rotavirus vaccine to prevent rotavirus diarrhea
The polio and rotavirus randomized clinical trials are embedded as secondary objectives within the exploratory study of tropical enteropathy. The primary and secondary outcome measures are relevant to the randomized clinical trials.
Eligibility Criteria
Inclusion Criteria
- Mother willing to sign informed consent form.
- Healthy infant aged 0 to 7 days old.
- No obvious congenital abnormalities or birth defects.
- No abnormal (frequency and consistency) stools since birth.
- Stable household with no plans to leave the area for the next one year.
Exclusion Criteria
- Parents are not willing to have child vaccinated at the field clinic.
- Parents are not willing to have child's blood drawn.
- Parents are planning to enroll child into another clinical study during the time period of this trial.
- Mother not willing to have blood drawn and breast milk extracted.
- Parents not willing to have field research assistant in home two times per week.
- History of seizures or other apparent neurologic disorders.
- Infant received any vaccines before start of study, except Bacillus Calmette-Guerin (BCG).
- Infant has any sibling currently or previously enrolled in this study, including a twin.
Data sourced from ClinicalTrials.gov (NCT01375647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.