The effect of increased inoculum on oral rotavirus vaccine take among infants in Dhaka, Bangladesh: A double-blind, parallel group, randomized, controlled trial

•Oral rotavirus vaccines underperform in low-income countries.•A double vaccine dose did not improve immune response among infants in Bangladesh.•Infants with vaccine replication had improved antibody responses.•Interventions to improve gut health and promote vaccine replication are needed. Oral, li...

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Bibliographic Details
Published in:Vaccine 2020-01, Vol.38 (1), p.90-99
Main Authors: Lee, Benjamin, Dickson, Dorothy M., Alam, Masud, Afreen, Sajia, Kader, Abdul, Afrin, Faria, Ferdousi, Tania, Damon, Christina F., Gullickson, Soyeon K., McNeal, Monica M., Bak, Daniel M., Tolba, Mona, Carmolli, Marya P., Taniuchi, Mami, Haque, Rashidul, Kirkpatrick, Beth D.
Format: Article
Language:English
Subjects:
Administration, Oral
Babies
Bangladesh - epidemiology
Childbirth & labor
Children
Clinical trials
Congenital defects
Dosage
Dose-Response Relationship, Drug
Double-Blind Method
Double-blind studies
Enrollments
Female
Humans
Immunization
Immunization, Secondary - methods
Immunogenicity
Immunoglobulin A
Income
Infant
Infants
Inoculum
Low income areas
Low income groups
Male
Oral vaccine
Pediatrics
Pharmacists
Polymerase chain reaction
Randomization
Replication
Reverse transcription
Rotavirus
Rotavirus Infections - epidemiology
Rotavirus Infections - immunology
Rotavirus Infections - prevention & control
Rotavirus Vaccines - administration & dosage
Rotavirus Vaccines - immunology
Seroconversion
Treatment Outcome
Vaccine shedding
Vaccine take
Vaccine underperformance
Vaccines
Vaccines, Attenuated - administration & dosage
Vaccines, Attenuated - immunology
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Summary:•Oral rotavirus vaccines underperform in low-income countries.•A double vaccine dose did not improve immune response among infants in Bangladesh.•Infants with vaccine replication had improved antibody responses.•Interventions to improve gut health and promote vaccine replication are needed. Oral, live-attenuated rotavirus vaccines suffer from impaired immunogenicity and efficacy in low-income countries. Increasing the inoculum of vaccine might improve vaccine response, but this approach has been inadequately explored in low-income countries. We performed a double-blind, parallel group, randomized controlled trial from June 2017 through June 2018 in the urban Mirpur slum of Dhaka, Bangladesh to compare vaccine take (primary outcome) among healthy infants randomized to receive either the standard dose or double the standard dose of oral Rotarix (GlaxoSmithKline) vaccine at 6 and 10 weeks of life. Infants with congenital malformations, birth or enrollment weight
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2019.09.088