- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02992197
The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity
A Double-blind, Randomized Controlled Trial of the Effect of Vaccine Inoculum on Oral Rotavirus Vaccine (Rotarix, GlaxoSmithKline) Take and Immunogenicity in Dhaka, Bangladesh
Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines work remarkably well in high-income countries, but for unclear reasons they underperform in low-income countries. A double-blind, randomized control trial will be performed to evaluate whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can improve immune responses among infants in Dhaka, Bangladesh.
Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6 and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum rotavirus-specific IgA responses to determine vaccine immunogenicity.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Dhaka, Bangladesh
- International Center for Diarrhoeal Disease Research, Bangladesh (icddr,b)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Generally healthy infant (as determined by medical officers)
- Age 0-7 days at enrolment
- Mother willing and able to provide signed informed consent
- Mother willing to allow infant to be vaccinated according to study schedule
- Mother willing to allow biological specimens, including blood, stool, and saliva, to be collected from infant according to study protocol
- Mother willing and able to adhere to study schedule
Exclusion Criteria:
- Obvious congenital malformation
- Birth weight (if known) or enrolment weight (if birth weight unknown) < 2000 gm
- Known immunocompromising condition in infant
- Enrolment in other vaccine research trials
- Other household member enrolled in this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Rotarix, single dose
Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life
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Rotarix, dose 1
Sterile water to provide volume equivalent as a second dose of Rotarix
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EXPERIMENTAL: Rotarix, double dose
Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life
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Rotarix, dose 1
Rotarix, dose 2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number (or Percentage) of Infants in Each Study Arm Who Test Positive for Fecal Rotavirus Vaccine-strain Virus Shedding Post-vaccination
Time Frame: Measured through week 12 of life
|
This will be an aggregate measure demonstrating a change from baseline.
Infants will have stool collected immediately prior to Rotarix vaccination at weeks 6 and 10 of life, then 4, 7, and 14 days following each dose (i.e. last assessment at week 12 of life).
Each specimen will be assessed for vaccine-strain virus (i.e.
fecal vaccine shedding) at each time point by polymerase chain reaction.
Any child who has a change in fecal vaccine shedding status, from negative at baseline (6 weeks) to positive at any subsequent time point, will be categorized as having met the outcome measure for positive fecal vaccine shedding.
|
Measured through week 12 of life
|
Number (or Percentage) of Infants in Each Study Arm With Rotavirus-specific Plasma Immunoglobulin A (IgA) Seroconversion Post-vaccination
Time Frame: Measured at week 14 of life
|
This outcome will measure seroconversion, i.e. the change in plasma rotavirus-specific IgA concentration at week 14 of life compared to week 6 of life (baseline).
Blood will be collected from infants prior to the first dose of Rotarix at week 6 of life and again at week 14 of life (4 weeks following the second dose) for measurement of plasma rotavirus-specific IgA by enzyme immunoassay.
Infants will be assessed for seroconversion (IgA concentration <=20 U/mL pre-vaccination and >20 post-vaccination).
Infants who demonstrate rotavirus-specific IgA seroconversion will be categorized as having met the outcome measure.
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Measured at week 14 of life
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Number (or Percentage) of Infants in Each Study Arm With Successful Vaccine Take, Defined as Positive Fecal Vaccine Shedding Post-vaccination OR Rotavirus-specific Plasma IgA Seroconversion Post-vaccination
Time Frame: Measured at week 14 of life
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Vaccine take is an aggregate, dichotomous immunogenicity measure (successful vaccine take vs no vaccine take).
Infants positive for either fecal vaccine shedding OR plasma rotavirus-specific IgA seroconversion (as described in Outcomes 1 and 2, respectively) will be categorized as having met the outcome measure of successful vaccine take.
Those who met neither outcome will be categorized as no vaccine take.
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Measured at week 14 of life
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Benjamin Lee, M.D., University of Vermont
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRMS 17-0166
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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