Effectiveness of Pentavalent Rotavirus Vaccine Against a Diverse Range of Circulating Strains in Nicaragua

Patel, Manish; Pedreira, Cristina; Oliveira, Lúcia Helena de; Tate, Jacqueline E.; Leshem, Eyal; Mercado, Juan Carlos; Umaña, Jazmina; Balmaceda, Angel; Reyes, Martha; Kerin, Tara; McDonald, Sharla; Gentsch, Jon R.; Bowen, Michael D.; Parashar, Umesh D.

doi:10.1093/cid/civ1017

Cited by 26 publications

(11 citation statements)

References 27 publications

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“…Similar observations were also reported in other developing and developed countries (37,39). In countries with high coverage of RotaTeq R , increases in the prevalence of uncommon and unusual strains were reported (40,41).…”

Section: Discussionsupporting

confidence: 86%

Genetic Diversity of Human Rotavirus A Among Hospitalized Children Under-5 Years in Lebanon

et al. 2020

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Human rotavirus remains a major cause of gastroenteritis worldwide despite the availability of effective vaccines. In this study, we investigated the genetic diversity of rotaviruses circulating in Lebanon. We genetically characterized the VP4 and VP7 genes encoding the outer capsid proteins of 132 rotavirus-associated gastroenteritis specimens, previously identified in hospitalized children (<5 years) from 2011 to 2013 in Lebanon. These included 43 vaccine-breakthrough specimens and the remainder were from non-vaccinated subjects. Phylogenetic analysis of VP4 and VP7 genes revealed distinct clustering compared to the vaccine strains, and several substitutions were identified in the antigenic epitopes of Lebanese specimens. No unique changes were identified in the breakthrough specimens compared to non-breakthroughs that could explain the occurrence of infection in vaccinated children. Further, we report the emergence of a rare P[8] OP354-like strain with a G9 VP7 in Lebanon, possessing high genetic variability in their VP4 compared to vaccine strains. Therefore, human rotavirus strains circulating in Lebanon and globally have accumulated numerous substitutions in their antigenic sites compared to those currently used in the licensed vaccines. The successful spread and continued genetic drift of these strains over time might undermine the effectiveness of the vaccines. The effect of such changes in the antigenic sites on vaccine efficacy remains to be assessed.

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Section: Discussionsupporting

confidence: 86%

Genetic Diversity of Human Rotavirus A Among Hospitalized Children Under-5 Years in Lebanon

et al. 2020

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“…In Latin America, countries including Nicaragua and Bolivia, and in Africa; Malawi, Ghana, Botswana, Rwanda, and Zambia have successfully demonstrated reductions in rotavirus associated hospitalizations (45–75%) (Table 1) [26], [27], [28], [29], [30], [31], [32], [33]. In a number of studies in these countries however, a decline in vaccine effectiveness in the second year of life has been reported.…”

Section: Rotavirus Disease Is a Vaccine Preventable Diseasementioning

confidence: 99%

The rotavirus vaccine development pipeline

Kirkwood

Carey

et al. 2019

Vaccine

106

177

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Rotavirus disease is a leading global cause of mortality and morbidity in children under 5years of age. The effectiveness of the two globally used oral rotavirus vaccines quickly became apparent when introduced into both developed and developing countries, with significant reductions in rotavirus-associated mortality and hospitalizations. However, the effectiveness and impact of the vaccines is reduced in developing country settings, where the burden and mortality is highest. New rotavirus vaccines, including live oral rotavirus candidates and non-replicating approaches continue to be developed, with the major aim to improve the global supply of rotavirus vaccines and for local implementation, and to improve vaccine effectiveness in developing settings. This review provides an overview of the new rotavirus vaccines in development by developing country manufacturers and provides a rationale why newer candidates continue to be explored. It describes the new live oral rotavirus vaccine candidates as well as the non-replicating rotavirus vaccines that are furthest along in development.

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“…1 Two rotavirus vaccines, Rotarix (GSK, Rixensart, Belgium) and RotaTeq (Merck, Whitehouse Station, USA) have reduced hospital admissions and child deaths from diarrhea in settings where vaccine has been introduced in national immunisation programs. [2][3][4][5][6][7] However, Rotarix and RotaTeq have lower vaccine effectiveness in low income countries when compared with high-income countries. [8][9][10] Several host and environmental factors have been suggested to play a role in the lower vaccine effectiveness.…”

Section: Introductionmentioning

confidence: 99%

Rotavirus shedding following administration of RV3-BB human neonatal rotavirus vaccine

Cowley

Boniface

Bogdanovic-Sakran

et al. 2017

Human Vaccines & Immunotherapeutics

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The RV3-BB human neonatal rotavirus vaccine aims to provide protection from severe rotavirus disease from birth. A phase IIa safety and immunogenicity trial was undertaken in Dunedin, New Zealand between January 2012 and April 2014. Healthy, full-term (≥ 36 weeks gestation) babies, who were 0-5 d old were randomly assigned (1:1:1) to receive 3 doses of oral RV3-BB vaccine with the first dose given at 0-5 d after birth (neonatal schedule), or the first dose given at about 8 weeks after birth (infant schedule), or to receive placebo (placebo schedule). Vaccine take (serum immune response or stool shedding of vaccine virus after any dose) was detected after 3 doses of RV3-BB vaccine in >90% of participants when the first dose was administered in the neonatal and infant schedules. The aim of the current study was to characterize RV3-BB shedding and virus replication following administration of RV3-BB in a neonatal and infant vaccination schedule. Shedding was defined as detection of rotavirus by VP6 reverse transcription polymerase chain reaction (RT-PCR) in stool on days 3-7 after administration of RV3-BB. Shedding of rotavirus was highest following vaccination at 8 weeks of age in both neonatal and infant schedules (19/30 and 17/27, respectively). Rotavirus was detected in stool on days 3-7, after at least one dose of RV3-BB, in 70% (21/30) of neonate, 78% (21/27) of infant and 3% (1/32) placebo participants. In participants who shed RV3-BB, rotavirus was detectable in stool on day 1 following RV3-BB administration and remained positive until day 4-5 after administration. The distinct pattern of RV3-BB stool viral load demonstrated using a NSP3 quantitative qRT-PCR in participants who shed RV3-BB, suggests that detection of RV3-BB at day 3-7 was the result of replication rather than passage through the gastrointestinal tract.

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Effectiveness of Pentavalent Rotavirus Vaccine Against a Diverse Range of Circulating Strains in Nicaragua

Abstract: Introduction of RotaTeq did not result in sustained emergence of any particular strain in Nicaragua. Variation in strain-specific effectiveness was due to an age-related decline in effectiveness rather than differences in protection against the observed strains.

Cited by 26 publications

References 27 publications

Genetic Diversity of Human Rotavirus A Among Hospitalized Children Under-5 Years in Lebanon

Genetic Diversity of Human Rotavirus A Among Hospitalized Children Under-5 Years in Lebanon

The rotavirus vaccine development pipeline

Rotavirus shedding following administration of RV3-BB human neonatal rotavirus vaccine

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