Rotavirus Vaccine Very Effective At Stopping Gastroenteritis Episodes In Children

Main Category: Pediatrics / Children's Health
Also Included In: GastroIntestinal / Gastroenterology;  Immune System / Vaccines
Article Date: 24 Nov 2007 - 0:00 PST

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Two doses of a rotavirus vaccine co-administered with childhood vaccines provides high protection against rotavirus gastroenteritis episodes of any severity in children, and also reduces the need for hospital treatment and medical attention related to the condition. These are the conclusions of authors of an Article in this week's edition of The Lancet.

Professor Timo Vesikari, Vaccine Research Centre, Medical School, University of Tampere, Finland, and colleagues, did a study of 3994 children aged between six and 14 weeks from France, Italy, Spain, Finland, Germany, and the Czech Republic, of which around two-thirds were randomly assigned two oral doses of the RIX4414 rotavirus vaccine and around one-third were randomly assigned placebo. The vaccine was co-administered with the first two doses of specific childhood immunisations. The children were then followed up from two-weeks post dose through the two consecutive rotavirus seasons, for an average 17 months. Stool specimens obtained during gastroenteritis episodes were tested for rotavirus.

The researchers found that during the first efficacy follow-up period (average 5•7 months), 24 of 2572 infants given the vaccine had rotavirus gastroenteritis episodes of any severity, versus 94 out of 1302 given placebo, giving a vaccine efficacy of 87•1%. After both doses, vaccine efficacy against any severity rotavirus gastroenteritis remained high at 78•9% over two consecutive rotavirus seasons; while against severe rotavirus gastroenteritis efficacy was 90•4%, for admission owing to rotavirus gastroenteritis it was 96•0%, and for rotavirus-related medical attention 83•8%. Further, significant protection against severe rotavirus gastroenteritis by various circulating rotavirus types was shown.

The authors say: "Our findings confirm the high incidence of rotavirus gastroenteritis during the first two years of life and, hence, a need for long-term protection induced by rotavirus vaccination. The human rotavirus vaccine RIX4414 showed high and sustained efficacy against severe rotavirus gastroenteritis and admission for rotavirus gastroenteritis."

They conclude: "Our study findings show that, if integrated into routine infant immunisation schedules, vaccination with RIX4414 could result in significant reduction not only of rotavirus disease burden but also of severe paediatric gastroenteritis during the first two years of life."

In an accompanying Comment, Professor Keith Grimwood, Royal Children's Hospital, Department of Paediatrics and Child Health, University of Queensland, Brisbane, QLD, Australia, and Prof Julie Bines, University of Melbourne and Royal Children's Hospital, Murdoch Children's Research Institute, Melbourne, VIC, Australia, say that due to rotavirus strain diversity in Africa and Asia, no global recommendations for rotavirus vaccines can be made until vaccine trials are completed in these regions.

They conclude: "Low-income countries must also address vaccine and delivery costs and the timing of immunisation, and develop communication strategies informing families that rotavirus vaccines cannot prevent all diarrhoeal episodes. If these goals are achieved the ultimate aim of reduction of death and suffering globally from rotavirus could finally be attained."

http://www.thelancet.com