Meta-analysis of the effectiveness of pentavalent live oral vaccine for the prevention of severe forms of rotavirus gastroenteritis in children

Rotavirus infection is ubiquitously distributed and represents a global public health problem. Some studies showed that vaccination with pentavalent oral live vaccine was effective in prevention of severe forms of rotavirus gastroenteritis among children up to 3 years of age. Previous randomized placebo-controlled studies assessing this issue were repeatedly conducted. However, due to the features of the epidemiology of pediatric rotavirus infection in Russia, a metaanalysis was conducted in the risk group — children under the age of 3 years by administering a full vaccination course for a single vaccine registered in the Russian Federation. A search was performed by two independent reviewers covering 1994 to February 2019, without restrictions on language, in five databases on medical and biological publications: Russian Science Citation Index, PubMed, Web of Science, MEDLINE, Scopus, and in contents of thematic journals and bibliographic lists. The meta-analysis included multicenter randomized controlled trials comparing the efficacy of placebo and completed full vaccination course with pentavalent live oral rotavirus vaccine in children under 3 years of age. The primary endpoint of the study was the incidence of severe gastroenteritis among children according to the Vesikari evaluation system. Data processing and generation of forest-plots to evaluate summarized results were carried out by the RevMan 5.3 free software distributed on the Cochrane Community website. The implementation of the “trim and fill” method was performed by using Stata 14.2 software. The meta-analysis consisted of 7 original publications performed as multicenter randomized, placebo-controlled double-blind studies. In the experimental and control group there were enrolled 19,384 and 19,425 subjects, respectively. Three-dose vaccination protocol markedly reduced a risk of infection with severe rotavirus gastroenteritis in the experimental group compared to control group, the odds ratio was 0.34 [95%, CI 0.19—0.60]. Cluster analysis also confirmed the protective effect of the full vaccination course. Group assessment of the vaccination effectiveness against rotavirus infection in countries of Africa and Southeast Asia showed significant protection, the odds ratio was 0.60 [95%, CI 0.52—0.70]. While evaluating the effectiveness of vaccination against rotavirus infection in Finland, the odds ratio was set at the level of statistical significance and reached 0.07 [95%, CI 0.04—0.11]. Thus, a full vaccination course with pentavalent live oral vaccine against rotavirus infection lowers a risk of developing severe rotavirus gastroenteritis in young children.