Norovirus gastroenteritis in young children receiving human rotavirus vaccine

Abstract

We explored whether human rotavirus vaccine had any efficacy against norovirus (NV)-associated gastroenteritis in young children. In an efficacy trial of rotavirus vaccine, 405 infants were immunized with a human rotavirus vaccine or placebo at a ratio of 2:1, and prospectively followed for acute gastroenteritis (AGE) from approximately 2 months to 2 y of age. Multiplex real-time reverse transcription polymerase chain reaction (Mrt RT-PCR) assays were used for detection and quantitation of NVs of genogroup I (GI) and genogroup II (GII) in stool specimens. NVs were detected in 155 (32%) of 485 episodes of AGE. Of these, NV was the only gastroenteritis virus detected in the stools in 142 (29%) episodes. GI and GII NVs were found in 12% and 88% of the cases, respectively. NV as the only gastroenteritis virus was detected in 36% of the infants in the rotavirus vaccine group and 27% in the placebo group. The clinical severity of NV-associated AGE in the vaccine and placebo recipients was not different. NVs were the most common etiologic agents of AGE in children under 2 y of age. Human rotavirus vaccine did not protect against NV gastroenteritis.

Acknowledgements

We thank the study physicians and study nurses for the collection of clinical information and stool specimens, and Silvia Damaso of GlaxoSmithKline Biologicals for collaboration in the data analysis. We thank Mika Helminen for statistical analyses. We also acknowledge all the technicians who work at the laboratory of the Vaccine Research Centre at the University of Tampere Medical School for their technical assistance.

Declaration of interest: The trial of RIX4414 rotavirus vaccine was supported by GlaxoSmithKline.