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

University of Vermont

Status and phase: Completed; Phase 4

Conditions: Vaccine Response Impaired; Vaccine Virus Shedding; Rotavirus Infection

Treatments: Drug: Placebo (for Rotarix dose 2); Biological: Rotarix, dose 1; Biological: Rotarix, dose 2

Study type: Interventional

Funder types: Other

Identifiers

NCT02992197

CHRMS 17-0166

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: Under 15 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups

Rotarix, single dose

Active Comparator group

Description:

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

Treatment:

Drug: Placebo (for Rotarix dose 2)

Biological: Rotarix, dose 1

Rotarix, double dose

Experimental group

Description:

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

Treatment:

Biological: Rotarix, dose 1

Biological: Rotarix, dose 2