Rotavirus is the most common aetiology of serious diarrhoea in young children. Despite antibiotics not being indicated in its treatment, diarrhoea remains a very common cause for antibiotic prescribing in low-income settings. We hypothesized that effective rotavirus vaccination could reduce diarrhoeal episodes and thereby unnecessary antibiotic usage in young children in low-income settings. The study aimed to evaluate the impact of rotavirus vaccination on antibiotic usage. Specifically, the study quantified how differences in rotavirus vaccine efficacy would impact days of prescription and nonprescription antibiotic usage in the first 2 years of life among two large cohorts of children in Zambia and Ghana. The key goal was to understand the effect of rotavirus vaccine efficacy on antibiotic usage and household antibiotic costs. The goal was to generate evidence needed to inform policymakers seeking to introduce new rotavirus vaccines into national vaccination programs, of potential, and often under-appreciated, secondary effects of rotavirus vaccine implementation on antibiotic usage. The study was conducted within a Phase III randomised controlled trial comparing the efficacy of a new parenteral trivalent P2-VP8 subunit rotavirus vaccine to the oral live attenuated vaccine, Rotarix®, against severe rotavirus gastroenteritis in the first 2 years of life in Zambia and Ghana.
Study Type
OBSERVATIONAL
Enrollment
1,600
Trivalent P2-VP8 subunit rotavirus vaccine
Noguchi Memorial Institute of Medical Research-University of Ghana
Accra, Ghana
Center for Infectious Disease Research in Zambia
Lusaka, Lusaka Province, Zambia
To assess the relative efficacy of the TV P2-VP8 vaccine in comparison to Rotarix® in reducing prescription and non-prescription antibiotic consumption in the first two years of life.
Time frame: 2 years
• To assess the relative efficacy of the TV P2-VP8 vaccine in comparison to Rotarix® in reducing recurrent antibiotic consumption in the first two years of life.
Time frame: 2 years
• To assess the relative efficacy of the TV P2-VP8 vaccine in comparison to Rotarix® in reducing household prescription and non-prescription antibiotic costs in the first two years of life.
Time frame: 2 years
• To assess the background incidence of antibiotic usage in the community in the first two years of life.
Time frame: 2 years
• To assess the relationship between frequency of antibiotic use and faecal bacterial microbiome composition, ARG abundance and bacterial metabolites in the urine over the first two years of life.
Time frame: 2 years
• To assess the relationship between RVV efficacy (TV P2-VP8 and Rotarix) and faecal bacterial microbiome composition over the first two years of life.
Time frame: 2 years
• Verification of weekly recall and medicine cabinet review of antibiotic use through assessment of antibiotic metabolites in the urine.
Time frame: 2 years
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