Human rotavirus vaccine Rotarix™ provides protection against diverse circulating rotavirus strains in African infants: a randomized controlled trial

Background Rotaviruses are the most important cause of severe acute gastroenteritis worldwide in children <5 years of age. The human, G1P[8] rotavirus vaccine Rotarix™ significantly reduced severe rotavirus gastroenteritis episodes in a Phase III clinical trial conducted in infants in South Afric...
Ausführliche Beschreibung

Background Rotaviruses are the most important cause of severe acute gastroenteritis worldwide in children <5 years of age. The human, G1P[8] rotavirus vaccine Rotarix™ significantly reduced severe rotavirus gastroenteritis episodes in a Phase III clinical trial conducted in infants in South Africa and Malawi. This paper examines rotavirus vaccine efficacy in preventing severe rotavirus gastroenteritis, during infancy, caused by the various G and P rotavirus types encountered during the first rotavirus-season. Methods Healthy infants aged 5–10 weeks were enrolled and randomized into three groups to receive either two (10 and 14 weeks) or three doses of Rotarix™ (together forming the pooled Rotarix™ group) or three doses of placebo at a 6,10,14-week schedule. Weekly home visits were conducted to identify gastroenteritis episodes. Rotaviruses were detected by ELISA and genotyped by RT-PCR and nucleotide sequencing. The percentage of infants with severe rotavirus gastroenteritis caused by the circulating G and P types from 2 weeks post-last dose until one year of age and the corresponding vaccine efficacy was calculated with 95% CI. Results Overall, 4939 infants were vaccinated and 4417 (pooled Rotarix™ = 2974; placebo = 1443) were included in the per protocol efficacy cohort. G1 wild-type was detected in 23 (1.6%) severe rotavirus gastroenteritis episodes from the placebo group. This was followed in order of detection by G12 (15 [1%] in placebo) and G8 types (15 [1%] in placebo). Vaccine efficacy against G1 wild-type, G12 and G8 types were 64.1% (95% CI: 29.9%; 82%), 51.5% (95% CI:-6.5%; 77.9%) and 64.4% (95% CI: 17.1%; 85.2%), respectively. Genotype P[8] was the predominant circulating P type and was detected in 38 (2.6%) severe rotavirus gastroenteritis cases in placebo group. The remaining circulating P types comprised of P[4] (20 [1.4%] in placebo) and P[6] (13 [0.9%] in placebo). Vaccine efficacy against P[8] was 59.1% (95% CI: 32.8%; 75.3%), P[4] was 70.9% (95% CI: 37.5%; 87.0%) and P[6] was 55.2% (95% CI: -6.5%; 81.3%) Conclusions Rotarix™ vaccine demonstrated efficacy against severe gastroenteritis caused by diverse circulating rotavirus types. These data add to a growing body of evidence supporting heterotypic protection provided by Rotarix™. Trial registration number NCT00241644 Ausführliche Beschreibung

Autor*in:	Steele, Andrew Duncan [verfasserIn] Neuzil, Kathleen M Cunliffe, Nigel A Madhi, Shabir A Bos, Pieter Ngwira, Bagrey Witte, Desiree Todd, Stacy Louw, Cheryl Kirsten, Mari Aspinall, Sanet Van Doorn, Leen Jan Bouckenooghe, Alain Suryakiran, Pemmaraju V Han, Htay Htay

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2012

Schlagwörter:	Gastroenteritis Vaccine Efficacy Rotarix Severe Gastroenteritis Gastroenteritis Episode

Anmerkung:	© Steele et al.; licensee BioMed Central Ltd. 2012

Übergeordnetes Werk:	Enthalten in: BMC infectious diseases - London : BioMed Central, 2001, 12(2012), 1 vom: 13. Sept.
Übergeordnetes Werk:	volume:12 ; year:2012 ; number:1 ; day:13 ; month:09

Links:	Volltext

DOI / URN:	10.1186/1471-2334-12-213

Katalog-ID:	SPR027868680