The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-12

Study Completion Date

2018-06-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Rotavirus Infection Vaccine Response Impaired Vaccine Virus Shedding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Rotarix, dose 1

Intervention Type BIOLOGICAL

Rotarix, dose 1

Placebo (for Rotarix dose 2)

Intervention Type DRUG

Sterile water to provide volume equivalent as a second dose of Rotarix

Rotarix, double dose

Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life

Group Type EXPERIMENTAL

Rotarix, dose 1

Intervention Type BIOLOGICAL

Rotarix, dose 1

Rotarix, dose 2

Intervention Type BIOLOGICAL

Rotarix, dose 2

Interventions

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Rotarix, dose 1

Intervention Type BIOLOGICAL

Rotarix, dose 2

Intervention Type BIOLOGICAL

Placebo (for Rotarix dose 2)

Sterile water to provide volume equivalent as a second dose of Rotarix

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Generally healthy infant (as determined by medical officers)
2. Age 0-7 days at enrolment
3. Mother willing and able to provide signed informed consent
4. Mother willing to allow infant to be vaccinated according to study schedule
5. Mother willing to allow biological specimens, including blood, stool, and saliva, to be collected from infant according to study protocol
6. Mother willing and able to adhere to study schedule

Exclusion Criteria

1. Obvious congenital malformation
2. Birth weight (if known) or enrolment weight (if birth weight unknown) \< 2000 gm
3. Known immunocompromising condition in infant
4. Enrolment in other vaccine research trials
5. Other household member enrolled in this study

Maximum Eligible Age

15 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes