Clinical trial NCT02992197: The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rotavirus Infection
Vaccine Response Impaired
Vaccine Virus Shedding
Keywords: Rotavirus
Oral vaccines
Vaccine underperformance
Vaccine shedding
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Charles H. Hood Foundation
name: Thrasher Research Fund
First posted: 2016-12-14
Enrollment: 220
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number (or Percentage) of Infants in Each Study Arm Who Test Positive for Fecal Rotavirus Vaccine-strain Virus Shedding Post-vaccination
timeFrame: Measured through week 12 of life
measure: Number (or Percentage) of Infants in Each Study Arm With Rotavirus-specific Plasma Immunoglobulin A (IgA) Seroconversion Post-vaccination
timeFrame: Measured at week 14 of life
measure: 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
timeFrame: Measured at week 14 of life
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Center for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Study officials:
affiliation: University of Vermont
name: Benjamin Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee B, Dickson DM, Alam M, Afreen S, Kader A, Afrin F, Ferdousi T, Damon CF, Gullickson SK, McNeal MM, Bak DM, Tolba M, Carmolli MP, Taniuchi M, Haque R, Kirkpatrick BD. The effect of increased inoculum on oral rotavirus vaccine take among infants in Dhaka, Bangladesh: A double-blind, parallel group, randomized, controlled trial. Vaccine. 2020 Jan 3;38(1):90-99. doi: 10.1016/j.vaccine.2019.09.088. Epub 2019 Oct 10.