BackgroundA birth dose strategy using a neonatal rotavirus vaccine to target early
prevention of rotavirus disease may address remaining barriers to global
vaccine implementation.MethodsWe conducted a randomized, placebo-controlled trial in Indonesia to evaluate
the efficacy of an oral human neonatal rotavirus vaccine (RV3-BB) to prevent
rotavirus gastroenteritis. Healthy newborns received three doses of RV3-BB
administered in a neonatal schedule at 0-5 days, 8 and 14 weeks or infant
schedule at 8, 14 and 18 weeks, or placebo. Laboratory-confirmed rotavirus
gastroenteritis was graded using a modified Vesikari score. The primary
analysis was efficacy against severe rotavirus gastroenteritis from two
weeks after all doses to 18 months in the combined vaccine group (neonatal
and infant schedule) compared with placebo.ResultsVaccine efficacy against severe rotavirus gastroenteritis to 18 months was
63% in the combined vaccine group (95% CI 34, 80; p<0.001), 75% in the
neonatal vaccine group (95% confidence interval [CI] 44, 91; p<0.001) and
51% in the infant vaccine group (95% CI 7, 76; p=0.03) in the per protocol
analysis, with similar results in the intention-to-treat analysis. Vaccine
efficacy to 12 months was 94% in the neonatal vaccine group (95%CI 56, 99;
p=0.006). Vaccine take occurred in 78/83 (94%) in the neonatal vaccine group
and 83/84 (99%) in the infant vaccine group. The vaccine was well tolerated,
with similar incidence of adverse events in vaccine and placebo
recipients.ConclusionRV3-BB was efficacious, immunogenic and well-tolerated when administered in a
neonatal or infant schedule in Indonesia.
Over the past 40 years at Royal Children's Hospital, Melbourne the hospitalization rate due to primary idiopathic intussusception has marginally increased from 0.19 to 0.27 per 1000 live births. Diagnosis and treatment using air enema has been highly successful, resulting in a reduction in patients requiring surgery and reduced hospital stays.
A complex diet was found to be superior to an elemental diet in terms of the morphological and functional features of adaptation following massive small bowel resection.
The clinical case definition for intussusception may assist in the prompt identification of patients with intussusception and may provide an important tool for the future trials of enteric vaccines.
Objective To test the sensitivity and specificity of a clinical case definition of acute intussusception in infants to assist health-care workers in settings where diagnostic facilities are not available. Methods Prospective studies were conducted at a major paediatric hospital in Viet Nam (the National Hospital of Pediatrics, Hanoi) from November 2002 to December 2003 and in Australia (the Royal Children's Hospital, Melbourne) from March 2002 to March 2004 using a clinical case definition of intussusception. Diagnosis of intussusception was confirmed by air enema or surgery and validated in a subset of participants by an independent clinician who was blinded to the participant's status. Sensitivity of the definition was evaluated in 584 infants aged < 2 years with suspected intussusception (533 infants in Hanoi; 51 in Melbourne). Specificity was evaluated in 638 infants aged < 2 years presenting with clinical features consistent with intussusception but for whom another diagnosis was established (234 infants in Hanoi; 404 in Melbourne). Findings In both locations the definition used was sensitive (96% sensitivity in Hanoi; 98% in Melbourne) and specific (95% specificity in Hanoi; 87% in Melbourne) for intussusception among infants with sufficient data to allow classification (449/533 in Hanoi; 50/51 in Melbourne). Reanalysis of patients with missing data suggests that modifying minor criteria would increase the applicability of the definition while maintaining good sensitivity (96-97%) and specificity (83-89%). Conclusion The clinical case definition was sensitive and specific for the diagnosis of acute intussusception in infants in both a developing country and a developed country but minor modifications would enable it to be used more widely. Voir page 574 le résumé en français. En la página 574 figura un resumen en español.
IntroductionThe withdrawal of the first rotavirus vacc c cine to be licensed in the United States (RotaShield, Wyeth-Lederle Vaccines, Philadelphia, PA, United States), due to an unexpected association with intusc c susception, resulted in a major setback in the effort to reduce the global burden of rotavirus gastroenteritis.1-3 Although the risk of intussusception following imc c munization with RotaShield is low, it has posed a major challenge to the future development of a safe and effective vacc c cine.2 Largecscale clinical trials are now required to detect a risk of intussusception of < 1 in 10 000. [4][5][6] Baseline intussuscepc c tion surveillance is needed in sites where trials of rotavirus vaccines are planned, and postclicensure intussusception surc c veillance may also be required by some licensing agencies. Intussusception is the invagination of the bowel by a more proximal segment. The intussusception can be propelled disc c tally by peristalsis, resulting in intestinal obstruction and vascular compromise of the intestine. Prompt identification and reduction by air enema or hydrostatic enema or by surgery is vital to minimize the morbidity and mortality that may be associat...
This study documents the epidemiology of intussusception in Australia from 1994 to 2000 and provides important baseline information for future rotavirus vaccines. A lower risk of intussusception was identified in indigenous compared to non-indigenous infants.
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