Long-term Consistency in Rotavirus Vaccine Protection: RV5 and RV1 Vaccine Effectiveness in US Children, 2012–2013

Abstract

Background. Using a multicenter, active surveillance network from 2 rotavirus seasons (2012 and 2013), we assessed the vaccine effectiveness of RV5 (RotaTeq) and RV1 (Rotarix) rotavirus vaccines in preventing rotavirus gastroenteritis hospitalizations and emergency department (ED) visits for numerous demographic and secular strata.Methods. We enrolled children hospitalized or visiting the ED with acute gastroenteritis (AGE) for the 2012 and 2013 seasons at 7 medical institutions. Stool specimens were tested for rotavirus by enzyme immunoassay and genotyped, and rotavirus vaccination histories were compared for rotavirus-positive cases and rotavirus-negative AGE controls. We calculated the vaccine effectiveness (VE) for preventing rotavirus associated hospitalizations and ED visits for each vaccine, stratified by vaccine dose, season, clinical setting, age, predominant genotype, and ethnicity.Results. RV5-specific VE analyses included 2961 subjects, 402 rotavirus cases (14%) and 2559 rotavirus-negative AGE controls. RV1-specific VE analyses included 904 subjects, 100 rotavirus cases (11%), and 804 rotavirus-negative AGE controls. Over the 2 rotavirus seasons, the VE for a complete 3-dose vaccination with RV5 was 80% (confidence interval [CI], 74%-84%), and VE for a complete 2-dose vaccination with RV1 was 80% (CI, 68%-88%).Statistically significant VE was observed for each year of life for which sufficient data allowed analysis (7 years for RV5 and 3 years for RV1). Both vaccines provided statistically significant genotype-specific protection against predominant circulating rotavirus strains.Conclusions. In this large, geographically and demographically diverse sample of US children, we observed that RV5 and RV1 rotavirus vaccines each provided a lasting and broadly heterologous protection against rotavirus gastroenteritis.

Changes in Rotavirus Genotypes before and after Vaccine Introduction: a Multicenter, Prospective Observational Study in Three Areas of Japan

“…However, G3P [8] drastically decreased after vaccine introduction, and G1P [8] predominated (97.1 ) in the 2012 13 season. Additionally, in the 2013 14 season, G2P [4] emerged, together with a decrease in the number of patients (Fig. 3A).…”

“…In Tsu City, G3P [8] was dominant (61.0-77.1 ) before vaccine introduction, but decreased after introduction. Meanwhile, in an inverse proportion to the decrease in G3P [8], G1P [8] increased until the 2013 14 season, when a sudden predominance of G2P [4] (100 ) occurred. A similar trend was observed in Kurashiki City in terms of the extent of reduction in G3P [8] and the emergence of G2P [4].…”

“…Meanwhile, in an inverse proportion to the decrease in G3P [8], G1P [8] increased until the 2013 14 season, when a sudden predominance of G2P [4] (100 ) occurred. A similar trend was observed in Kurashiki City in terms of the extent of reduction in G3P [8] and the emergence of G2P [4]. In Isumi City, G1P [8] was dominant (70.3 ) before vaccine introduction, and G9P [8] type.…”

“…In the second PCR am- plification, the T32 primer was used along with G1, G2, G3, G4, G8, and G9 genotype-specific primers, to identify the G types. For P typing, a pair of primers, 5′-TGGCTTCGTTCATTTATAGACA-3′ and 5′-CTA-AATGCTTTTGAATCATCCCA-3′, corresponding to the common sequences of the VP4 gene, including nucleotides 11-32 and 1,072-1,094, respectively, was used for the first amplification; a mixture of primers specific to each of the variable regions: P [8], P [4], P [6], and P [9], along with a primer corresponding to nucleotides 11-32, was used for the second amplification. The PCR products were separated using agarose gel electrophoresis, and the G and P types were confirmed based on the extent of migration (12,13).…”

“…Since 2006 when they were introduced, live attenuated RV vaccines have been part of the national immunization programs of various countries (2), and the efficacy and safety of these vaccines have been confirmed in many countries (3)(4)(5). In 2009, the World Health Organization recommended that all nations include an RV vaccine in their national immunization programs (1).…”