Trial reportThe Journal of infectious diseases2016
A Randomized, Controlled Trial of the Impact of Alternative Dosing Schedules on the Immune Response to Human Rotavirus Vaccine in Rural Ghanaian Infants.
Trial report in The Journal of infectious diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 42 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
42 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Vaccines for the common cold.The Cochrane database of systematic reviews · 2022Pooled it
- Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2021Pooled it
- Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019Pooled it
- Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019Pooled it
- Immunogenicity of different dosing schedules of the human live attenuate rotavirus vaccine (RV1) in infants and children: a meta-analysis.Human vaccines & immunotherapeutics · 2019Pooled it
- Trial
- Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants.Frontiers in public health · 2024Trial
- Timing of Rotavirus Vaccine Doses and Severe Rotavirus Gastroenteritis Among Vaccinated Infants in Low- and Middle-income Countries.Epidemiology (Cambridge, Mass.) · 2018Trial
- Effect of Antibiotic-Mediated Microbiome Modulation on Rotavirus Vaccine Immunogenicity: A Human, Randomized-Control Proof-of-Concept Trial.Cell host & microbe · 2018Trial
- Timing and predictors of severe rotavirus gastroenteritis among unvaccinated infants in low- and middle-income countries.Epidemiology and infection · 2018Trial
- Significant Correlation Between the Infant Gut Microbiome and Rotavirus Vaccine Response in Rural Ghana.The Journal of infectious diseases · 2017Trial
- Review
- Quantifying the Impact of Switching From Rotarix to Rotavac Rotavirus Vaccine in Ghana.The Journal of infectious diseases · 2026Article
- Mechanisms of maternal antibody interference with rotavirus vaccination.The EMBO journal · 2025Article
- Cost-effectiveness analysis of alternative infant and neonatal rotavirus vaccination schedules in Malawi.PLOS global public health · 2025Article
- Impact of dosing schedules on performance of rotavirus vaccines in Ghana.Science advances · 2024Article
- Impact of dosing schedules on performance of rotavirus vaccines in Ghana.medRxiv : the preprint server for health sciences · 2024Article
- Systematic review of the effect of additional doses of oral rotavirus vaccine on immunogenicity and reduction in diarrhoeal disease among young children.EClinicalMedicine · 2022Article
- Review
- Microneedle patch as a new platform to effectively deliver inactivated polio vaccine and inactivated rotavirus vaccine.NPJ vaccines · 2022Article
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe recommended schedule for receipt of 2-dose human rotavirus vaccine (HRV) coincides with receipt of the first and second doses of diphtheria, pertussis, and tetanus vaccine (ie, 6 and 10 weeks of age, respectively). Alternative schedules and additional doses of HRV have been proposed and may improve vaccine performance in low-income countries.
methodsIn this randomized trial in rural Ghana, HRV was administered at ages 6 and 10 weeks (group 1), 10 and 14 weeks (group 2), or 6, 10, and 14 weeks (group 3). We compared serum antirotavirus immunoglobulin A (IgA) seroconversion (≥20 U/mL) and geometric mean concentrations (GMCs) between group 1 and groups 2 and 3.
resultsNinety-three percent of participants (424 of 456) completed the study per protocol. In groups 1, 2, and 3, the IgA seroconversion frequencies among participants with IgA levels of <20 U/mL at baseline were 28.9%, 37.4%, and 43.4%, respectively (group 1 vs group 3, P = .014; group 1 vs group 2, P = .163). Postvaccination IgA GMCs were 22.1 U/mL, 26.5 U/mL, and 32.6 U/mL in groups 1, 2, and 3, respectively (group 1 vs group 3, P = .038; group 1 vs group 2, P = .304).
conclusionsA third dose of HRV resulted in increased seroconversion frequencies and GMCs, compared with 2 doses administered at 6 and 10 weeks of age. Since there is no correlate of protection, a postmarketing effectiveness study is required to determine whether the improvement in immune response translates into a public health benefit in low-income countries. CLINICAL TRIALS REGISTRATION: NCT015751.
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