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Completed

NCT Number: NCT02992197

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

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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Key information

Conditions

Rotavirus Infection Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Vaccine Response Impaired Vaccine Virus Shedding Virus Diseases

Age range

Up to 15 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

International Center for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotarix, dose 1

Biological

Rotarix, dose 1

Rotarix, dose 2

Biological

Rotarix, dose 2

Placebo (for Rotarix dose 2)

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

    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.

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • Charles H. Hood Foundation
  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Thrasher Research Fund

Registry information

Official study title

A Double-blind, Randomized Controlled Trial of the Effect of Vaccine Inoculum on Oral Rotavirus Vaccine (Rotarix, GlaxoSmithKline) Take and Immunogenicity in Dhaka, Bangladesh

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2016
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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