Safety and efficacy of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine in healthy premature infants

BACKGROUND: Premature infants seem to be at greater risk of hospitalization from rotavirus gastroenteritis than term infants. Safety and efficacy of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine were assessed in premature infants enrolled in the large-scale, blinded, placebo-controlled rotavirus efficacy and safety trial (REST). METHODS: Healthy infants 6-12 weeks of chronologic age at study entry were randomized to receive 3 oral doses of pentavalent rotavirus vaccine or placebo at 4- to 10-week intervals. Infants born at < or =36 weeks of gestational age were eligible if thriving at the time of enrollment. Safety and efficacy were retrospectively assessed in these premature infants comparing vaccine with placebo recipients. Cases of rotavirus gastroenteritis were defined as forceful vomiting and/or > or =3 watery or looser-than-normal stools within a 24-hour period, accompanied by detection of rotavirus antigen in the stool. RESULTS: A total of 2070 infants between 25 and 36 gestational weeks received at least 1 dose of vaccine or placebo; 1005 vaccine recipients and 1061 placebo recipients were evaluable for safety. Serious adverse events occurred in 55 vaccine recipients (5.5%) and 62 placebo recipients (5.8%). In a nested substudy of 308 premature infants evaluable for detailed safety (154 in each group), the frequencies of fever, diarrhea, vomiting, and irritability were comparable between vaccine and placebo recipients. Overall, 3 doses of the pentavalent vaccine reduced the rate of hospitalizations and emergency department visits in premature infants due to rotavirus gastroenteritis by 100% (95% CI: 82.2-100) compared with placebo. The vaccine also prevented 73.0% (95% CI: -2.2-95.2) of rotavirus gastroenteritis cases of any severity. CONCLUSIONS: In this post hoc analysis of healthy premature infants, the pentavalent rotavirus vaccine was generally well-tolerated and substantially reduced rotavirus-attributable hospitalizations and emergency department visits compared with placebo. Overall, vaccine safety and efficacy seemed to be generally comparable to the results in the REST study population as a whole. These results support vaccinating healthy premature infants on the same schedule as term infants.     

Probiotics for preventing healthcare-associated diarrhea in children: A meta-analysis of randomized controlled trials

Aim

To systematically update evidence on the efficacy of using probiotics for the prevention of healthcare-associated diarrhea in children.

Methods

MEDLINE, EMBASE, The Cochrane Library, Health Source: Nursing/Academic Edition, two clinical trials and reference lists were searched in June 2013, for randomized controlled trials (RCTs) performed in children aged 1 month to 18 years that compared the effects of the administration of probiotics with placebo or no intervention. The primary outcome measure was the incidence of healthcare-associated diarrhea.

Results

Six RCTs involving 1343 children met the inclusion criteria. Administration of Lactobacillus rhamnosus GG (LGG) compared with placebo reduced the risk of healthcare-associated diarrhea (2 RCTs, n = 823, RR 0.37; 95% CI 0.23–0.59), reduced the risk of rotavirus gastroenteritis (3 RCTs, n = 1043, RR 0.49, 95% CI 0.28–0.86), but did not reduce the risk of asymptomatic rotavirus infection (2 RCTs, n = 301, RR 1.39, 95% CI 0.74–2.62). Administration of Bifidobacterium bifidum & Streptococcus thermophilus compared with placebo reduced the risk of healthcare-associated diarrhea (1 RCT, n = 55, RR 0.22, 95% CI 0.05–0.96), rotavirus gastroenteritis (1 RCT, n = 55, RR 0.27, 95% CI 0.08–0.87), and rotavirus asymptomatic infection (1 RCT, n = 55, RR 0.27, 95% CI 0.08–0.87). Administration of two other probiotics (i.e., Lactobacillus reuteri DSM 17938 and Lactobacillus delbrueckii H2B20) was ineffective.

Conclusion

In hospitalized children, the administration of LGG, compared with placebo, reduced the incidence of healthcare-associated diarrhea, including rotavirus diarrhea. Evidence on the effects of other probiotics, whether positive or negative, is limited.     

Hospital surveillance of rotavirus infection and nosocomial transmission of rotavirus disease among children in Guinea-Bissau

BACKGROUND: Vaccination against rotavirus is protective against severe disease. Surveillance of rotavirus infection in developing countries might direct vaccination policy more efficiently. METHODS: We implemented WHO's generic protocols for hospital-and community-based surveillance of rotavirus gastroenteritis. From April 2001 to May 2002, and from January 2003 to June 2003, we conducted hospital surveillance for rotavirus infection at the only pediatric ward in the capital of Guinea-Bissau. Children less than 5 years of age admitted with diarrhea or developing diarrhea during hospitalization were enrolled in the study. Rotavirus infection was detected in the feces samples using an ELISA assay. Rectal swabs were also obtained and its use was validated against stool specimen. RESULTS: During the surveillance period, 161 cases of rotavirus infection were registered. During the season, rotavirus accounted for 35% of all hospitalized diarrhea cases. The rate of nosocomial disease was 1.6 per 1000 child-days (95% confidence interval [CI] = 1.02-2.51) with high rates for children aged 12 to 23 months of age (rate: 3.09; 95% CI = 1.47-6.48). Most of the rotavirus cases (93%) were in children less than 2 years of age and only 10 children aged less than 3 months were infected. Fever (risk ratio (RR) 1.56; 95% CI = 1.16-2.10) and vomiting (RR 1.38; 95% CI = 1.11-1.73) were more common in patients with rotavirus than in patients with nonrotavirus diarrhea. The case-fatality was 8%. Results from stool samples and rectal swabs were concordant in 96% of the pairs. Rectal swabs increased the detection of rotavirus cases by 6% and deaths by 33% over stool sample results. CONCLUSION: Rotavirus infections were confined to a 4-month period each year. It is an important cause of childhood diarrhea with high case-fatality ratio in Guinea-Bissau. The use of rectal swab appeared to increase the detection rate of rotavirus infection and the case-fatality rate. The high rate of nosocomial infections in hospitalized children emphasizes the need for prevention of disease.     

Efficacy of RIX4414 live attenuated human rotavirus vaccine in Finnish infants

BACKGROUND: Rotavirus gastroenteritis, a major cause of mortality and morbidity worldwide, is a vaccine-preventable disease. New safe and effective candidate rotavirus vaccines are needed to replace the withdrawn rhesus rotavirus-based oral vaccine. METHODS: We evaluated a monovalent human rotavirus vaccine, serotype G1, strain RIX4414, for efficacy, immunogenicity and safety in a randomized, double blind, placebo-controlled trial in Finland. We randomly allocated 405 healthy infants to receive 2 doses of vaccine or placebo (ratio 2:1) at approximately 2 and 4 months of age. The infants were followed during 2 rotavirus epidemic seasons (2000-2002) for acute gastroenteritis. Rotaviruses in diarrheal stool samples were primarily detected by enzyme-linked immunosorbent assay and confirmed and G-typed by reverse transciption-polymerase chain reaction. RESULTS: The vaccine was well-tolerated. No vaccine-related serious adverse events were observed during the study period. Rotavirus IgA (enzyme-linked immunosorbent assay) seroconversion rate was 80% after 2 doses. Thirty-eight cases of rotavirus gastroenteritis were detected during the entire follow-up period; 35 of these were of the G1 type. RIX4414 vaccine significantly decreased the occurrence of any rotavirus compared with placebo. Efficacy during the first rotavirus epidemic season was 73% [95% confidence interval (95% CI), 27-91%] and 90% (95% CI 10-100%) against any and severe rotavirus gastroenteritis, respectively, and during the entire follow-up period 72% (95% CI 42-87%) against any and 85% (95% CI 42-97%) against severe rotavirus gastroenteritis (P < 0.05 for all comparisons). CONCLUSIONS: RIX4414 strain of G1 human rotavirus vaccine was well-tolerated, immunogenic and efficacious in infants against rotavirus gastroenteritis during a 2-year period. To further increase vaccine "take" and efficacy, a higher dose of this vaccine may be considered for future efficacy trials.     

A case-control study to determine risk factors for hospitalization for rotavirus gastroenteritis in U.S. children

OBJECTIVE: The objective of this case-control study nested within a surveillance study conducted at 3 hospitals (Cincinnati Children's Hospital Medical Center, Cincinnati, OH; Children's Hospital of New Orleans, New Orleans, LA; and Hasbro Children's Hospital, Providence, RI) was to identify risk factors for rotavirus gastroenteritis requiring hospitalization. PATIENTS: Cases were children < or =59 months of age who were admitted with acute gastroenteritis (AGE) and found to have rotavirus infection. Controls were selected from a birth certificate registry (Cincinnati and Providence) or a registry of patients from a large practice consortium in 11 locations (New Orleans). RESULTS: Three hundred forty-nine rotavirus-infected cases and 1242 control subjects were enrolled. Breast feeding was protective against hospitalization for rotavirus AGE for infants <6 months of age. (odds ratio [OR], 5.1; 95% confidence interval [CI], 1.2-13.2). Low-birth-weight (<2500 g) infants had increased risk for hospitalization even beyond the first few months of life (OR, 2.8; 95% CI, 1.6-5.0). Children in child care were more likely to be hospitalized for rotavirus AGE than those cared for at home, particularly those > or =24 months of age (OR, 3.0; 95% CI, 1.8-5.3). Other characteristics associated with rotavirus AGE hospitalization were children <24 months of age covered by Medicaid or without insurance (OR, 2.1; 95% CI, 1.4-3.2) and having another child in the house <24 months of age (OR, 1.6; 95% CI, 1.1-2.3). The data suggest that maternal age <25 years (OR, 1.4; 95% CI, 1.0-2.0) and a mother with less than a high school education (OR, 1.5; 95% CI, 1.0-2.3) may also increase risk of rotavirus hospitalization. CONCLUSION: There are socioeconomic and environmental factors and aspects of the child's medical and dietary history that identify children at risk for hospitalization with rotavirus AGE.     

Safety, efficacy, and immunogenicity of a live, quadrivalent human-bovine reassortant rotavirus vaccine in healthy infants

OBJECTIVES: To investigate safety, efficacy, and immunogenicity of live quadrivalent rotavirus vaccine (QRV) containing human-bovine (WC3) reassortant rotavirus serotypes G1, G2, G3, and P1a. STUDY DESIGN: This was a randomized, double-blinded, placebo-controlled trial. During 1993 to 1994, at 10 US study sites, 439 healthy infants approximately 2 to 6 months of age, were enrolled to receive 3 doses of oral QRV or placebo at approximately 8-week intervals. RESULTS: The vaccine was generally well tolerated; no serious vaccine-related adverse experiences were reported. Risk differences and 95% confidence intervals suggested no differences between vaccine and placebo recipients in the incidences of fever, irritability, vomiting, or diarrhea during the 14 days after any dose. QRV was 74.6% efficacious (95% CI: 49.5%, 88.3%) in preventing rotavirus acute gastroenteritis (AGE), regardless of severity and 100% efficacious (95% CI: 43.5%, 100%) in preventing severe rotavirus AGE through one rotavirus season. Serotype G1 was identified in most infants with rotavirus AGE. A >or=3-fold rise in serum neutralizing antibody to G1 was observed in 57% (45/79) of vaccinees. A >or=3-fold rise in serum anti-rotavirus IgA and fecal anti-rotavirus IgA was observed in 88% (162/185) and 65% (104/159) of vaccinees, respectively. CONCLUSIONS: QRV was generally well tolerated, immungenic, and highly effective against rotavirus gastroenteritis.     

Increased beta-lactoglobulin absorption during rotavirus enteritis in infants: relationship to sugar permeability

We studied absorption of the potentially allergenic protein beta-lactoglobulin during acute rotavirus diarrhea in infants and assessed the relationship of this macromolecular absorption with intestinal sugar permeability. After oral rehydration, 38 patients with acute gastroenteritis were given orally a 100-ml solution containing 4 g (11.7 mmol/L) of lactulose and 0.8 g (4.4 mmol/L) of mannitol, and their recovery rate as shown in urine passed during the subsequent 5 h was measured. A blood sample was taken 2 h after a milk feed for ELISA measurement of beta-lactoglobulin in circulating immune complexes. Twelve nondiarrhea patients were studied after an overnight fast as controls. Immune complexes containing beta-lactoglobulin were found in the serum of all, but the levels [median (range)] were significantly higher in patients with rotavirus diarrhea [686 (36-4352)] than in nondiarrhea patients [165 (0-2594)]; p = 0.007. The mean (95% confidence interval) lactulose/mannitol urinary recovery ratios were increased in patients with acute diarrhea [0.19 (0.10, 0.30)] compared to nondiarrhea patients [0.01 (0.005, 0.02)]; p = 0.0001. Thus, a significant correlation between beta-lactoglobulin absorption and sugar permeability was found; Spearman's rank correlation coefficient = 0.42, p = 0.004. This correlation was not, however, direct but was due to an inverse relationship between urinary recovery of mannitol and serum beta-lactoglobulin immune complexes. These results indicate that rotavirus gastroenteritis is associated with enhanced beta-lactoglobulin absorption and elevated lactulose/mannitol permeability test results, but these represent different phenomena.     

Zinc with oral rehydration therapy reduces stool output and duration of diarrhea in hospitalized children: a randomized controlled trial

OBJECTIVES: The authors evaluated the effect of zinc treatment as an adjunct to oral rehydration therapy on stool output and diarrheal duration in children with acute noncholera diarrhea with dehydration. METHODS: This double-blind, randomized, controlled trial was conducted at two urban hospitals in New Delhi. A total of 287 dehydrated male patients, ages 3 to 36 months, with diarrhea for 12 months) and weight for height (65%-80% or >80% National Centre for Health Statistics median). Participants in the zinc group received 15 mg (12 months) elemental zinc daily in three divided doses for 14 days. The main outcome measures were stool output and diarrheal duration. RESULTS: Zinc treatment reduced total stool output (ratio of geometric means, 0.69; 95% confidence interval [CI]: 0.48, 0.99) and stool output per day of diarrhea (ratio of geometric means, 0.76; 95% CI: 0.59, 0.98). The risk of continued diarrhea was lower (relative hazards, 0.76; 95% CI: 0.59, 0.97) and the proportion of diarrheal episodes lasting >or= 5 days (odds ratio, 0.49; 95% CI: 0.25, 0.97) or >or= 7 days was less (odds ratio, 0.09; 95% CI: 0.01, 0.73) in the zinc group. CONCLUSIONS: This study demonstrates a beneficial effect of zinc administered during acute diarrhea on stool output, diarrheal duration, and proportion of episodes lasting more than 7 days. The effects are large enough to merit routine use of zinc during acute diarrhea in developing countries.     

Bovine lactoferrin supplementation for prevention of necrotizing enterocolitis in very-low-birth-weight neonates: a randomized clinical trial

ImportanceNEC is a common and severe complication in premature neonates, particularly those with very-low-birth-weight (VLBW, <1500 g at birth). Probiotics including lactobacillus rhamnosus GG (LGG) proved effective in preventing NEC in preterm infants in several RCTs.ObjectiveLactoferrin, a mammalian milk glycoprotein involved in innate immune host defences, can reduce the incidence of NEC in animal models, and its action is enhanced by LGG. We tried to assess whether bovine lactoferrin (BLF), alone or with the probiotic LGG, has a similar effect in human infants, something that has not yet been studied.DesignAn international, multicenter, randomized, double-blind, placebo-controlled trial conducted from October 1st, 2007 through July 31st, 2010.SettingThirteen Italian and New Zealand tertiary neonatal intensive care units.Participants743 VLBW neonates were assessed until discharge for development of NEC.InterventionInfants were randomly assigned to receive orally either BLF (100 mg/day) alone (group LF; n = 247) or with LGG (at 6×10⁹ CFU/day; group BLF + LGG; n = 238), or placebo (Control group; n = 258) from birth until day 30 of life (45 for neonates <1000 g at birth).Main outcome measures≥ stage 2 NEC; death-and/or-≥ stage 2 NEC prior to discharge.ResultsDemographics, clinical and management characteristics of the 3 groups were similar, including type of feeding and maternal milk intakes. NEC incidence was significantly lower in groups BLF and BLF + LGG [5/247 (2.0%)] and 0/238 (0%), respectively] than in controls [14/258 (5.4%)] (RR = 0.37; 95% CI: 0.136–1.005; p = 0.055 for BLF vs. control; RR = 0.00; p < 0.001 for BLF + LGG vs. control). The incidence of death-and/or-NEC was significantly lower in both treatment groups (4.0% and 3.8% in BLF and BLF + LGG vs. 10.1% in control; RR = 0.39; 95% CI: 0.19–0.80; p = 0.008. RR = 0.37; 95% CI: 0.18–0.77; p = 0.006, respectively). No adverse effects or intolerances to treatment occurred.Conclusions and relevanceCompared with placebo, BLF supplementation alone or in combination with LGG reduced the incidence of ≥ stage 2 NEC and of death-and/or ≥ stage 2 NEC in VLBW neonates. BLF might be a promising strategy to prevent NEC in NICU settings. Further data on larger sample sizes are warranted before BLF can be widespreadly used in clinical settings.Trial registrationISRCTN53107700–http://www.controlled-_trials.com/ISRCTN53107700.     

Effect of probiotic Lactobacillus strains on acute diarrhea in a cohort of nonhospitalized children attending day-care centers

BACKGROUND: Certain strains of lactobacilli have been shown to promote recovery from rotavirus enteritis in hospitalized children. Few studies have examined the effect of probiotics in nonhospitalized children with mild diarrhea. METHODS: We studied in a randomized placebo-controlled trial the effect of lyophilized Lactobacillus rhamnosus 19070-2 and Lactobacillus reuteri DSM 12246, 10(10) colony-forming units of each strain twice daily for 5 days, on acute diarrhea in children in a cohort of children recruited from local day-care centers. The duration of diarrhea and assessment of stool consistency were recorded by the parents. RESULTS: In patients treated with the selected Lactobacillus strains, the mean duration of diarrhea after intervention was reduced (76 h in patients treated with probiotics vs. 116 h in the placebo group; P = 0.05). In patients with diarrhea for <60 h before start of treatment (early intervention), a more pronounced effect of probiotics was found. The time to recovery after early treatment was 79 h vs. 139 h in the placebo group (P = 0.02); 1 of 17 patients treated early vs. 6 of 13 in the control group still had loose stools 120 h after start of treatment (P = 0.03). CONCLUSIONS: In children from day-care centers with mild gastroenteritis, the combination of L. rhamnosus 19070-2 and L. reuteri DSM 12246 was effective in reducing the duration of diarrhea.     

Randomized, placebo-controlled, clinical trial of hyperimmunized chicken egg yolk immunoglobulin in children with rotavirus diarrhea

BACKGROUND: Hyperimmunized bovine colostrum containing antibodies has been shown to be effective in the treatment of rotavirus diarrhea. Antibodies derived from eggs of immunized hens may be a less expensive and more practical alternative. In this study, children with proven rotavirus diarrhea were treated with immunoglobulin extracted from eggs of chicken immunized with human rotavirus strains. METHODS: In a randomized, double-blind study, 79 children with known rotavirus diarrhea were assigned to receive either 10 g hyperimmune egg yolk (HEY) daily in four equally divided doses for 4 days (HEY group) or a similar preparation obtained from nonimmunized chicken (placebo group). The daily stool frequency and amount, oral rehydration solution iORS) intake, and presence of rotavirus in the stool were monitored for 4 days. RESULTS: In the HEY-treated group, there was significant reduction in stool output (in grams per kilogram per day; HEY vs. placebo; 87+/-59 vs. 120+/-75, P = 0.03), and significant reduction of ORS intake (in milliliters per kilogram per day) (HEY vs. placebo; 84+/-46 vs. 122+/-72, P = 0.008) on day 1 and clearance of virus on day 4 (HEY vs. placebo; 73% vs. 46%, P = 0.02). There was, however, no difference in diarrheal duration between the groups. CONCLUSIONS: Treatment with HEY against four human rotavirus strains resulted in modest improvement of diarrhea associated with earlier clearance of rotavirus from stools. These results indicate an encouraging role of HEY in the treatment of rotavirus-induced diarrhea in children. Further studies are needed to optimize the dose and neutralization titer and thus improve the efficacy of egg yolk immunoglobulin IgY derived from immunized hens.     

Lactobacillus rhamnosus GG supplementation for preventing respiratory infections in children: A Meta-analysis of Randomized, Placebo-controlled Trials

Objective

To systematically review the effectiveness of administering Lactobacillus rhamnosus GG (LGG) for preventing respiratory infections in children.

Design

Systematic Review and Meta-analysis.

Data sources

Electronic databases and trial registries.

Results

Four RCTs involving 1805 participants met the inclusion criteria. Compared with placebo, LGG administration was associated with a reduced incidence of acute otitis media (four RCTs, n=1805, RR 0.76, 95% CI 0.64–0.91, fixed effects model, NNT 17, 95% CI 11–46), a reduced risk of upper respiratory infections (one RCT, n=281, RR 0.62, 95% CI 0.50–0.78, NNT 4, 95% CI 3–8) and antibiotic treatments (four RCTs, n=1805, RR 0.80, 95% CI 0.71–0.91, fixed effects model). There was no significant difference between the LGG and the control groups in the risk of overall respiratory infections and the incidence of lower respiratory infections. However, subgroup analysis of two studies on children older than 1 year showed significant reduction in the risk of overall respiratory infections (two RCTs, n=794, RR 0.73, 95% CI 0.57–0.92, random effects model, NNT 8, 95% CI 5–14). Adverse effects were similar in both groups. No serious adverse events were reported.

Conclusion

The administration of Lactobacillus rhamnosus GG compared with placebo has the potential to reduce the incidence of acute otitis media, the upper respiratory infections and antibiotic use in children.     

Impact of acute rotavirus gastroenteritis on pediatric outpatient practices in the United States

OBJECTIVES: The objectives of this study were to determine the presenting symptoms, healthcare utilization, and lost time from work and day care associated with acute rotavirus gastroenteritis. METHODS: During the winter to spring seasons of 2002-2003 or 2003-2004, children <36 months of age presenting with acute gastroenteritis to urban and suburban pediatric outpatient practices affiliated with 5 academic centers across the United States were enrolled in similarly designed studies. The case definition required >or=3 watery or looser-than-normal stools and/or forceful vomiting within a 24-hour period beginning 相似文献   

Nosocomial rotavirus infections in a general pediatric ward: epidemiology, molecular typing and risk factors]

OBJECTIVES: Nosocomial rotavirus infections induce difficult problems for pediatric wards during winter epidemics. This prospective study was carried out to measure their incidence in a general pediatric ward by using epidemiological tools, clinical and molecular methods, and to examine the main factors increasing the risk of cross contamination. MATERIAL AND METHODS: The study was carried out on children, younger than three years old, hospitalized between 15 November 1996 and 1 March 1997. We examined the feces of all children for rotavirus on admission and during their hospital stay if they had developed diarrhea. The strains were typed by RNA electrophoresis. A cohort study was done to identify the factors of exposure to risk. RESULTS: Three hundred twenty-six of the 415 hospitalized infants were studied. One hundred and five were hospitalized for gastroenteritis, including 39 (37.1%) with rotavirus infection. Among 221 infants admitted without diarrhea, 11 (5.0%) had an asymptomatic community infection and nine (4.3%) developed nosocomial gastroenteritis. The only significant predisposing factor (P = 0.003) for nosocomial infection was the distance between the hospital rooms and the nurses station. Despite the low level of typing (51%), the molecular study suggested a wide diversity of nosocomial and community strains. CONCLUSION: The relatively low incidence of nosocomial infections found may be due to routine assignment to individual rooms, the isolation of infants admitted with acute diarrhea, and the policy of routine detection of asymptomatic carriers with the use of similar isolation measures for these children.     

Rotavirus gastroenteritis among children under five years of age in Izmir, Turkey

Little is known about the epidemiology of rotavirus infection in Turkey. The aim of the study was to determine the incidence and clinical significance of rotavirus gastroenteritis, in view of the potentially available prevention by rotavirus vaccination. The study also sought to determine possible risk factors for rotavirus gastroenteritis. Therefore, 920 children under five years of age with acute gastroenteritis admitted to three pediatric hospitals in Izmir were studied. Rotavirus was identified in 39.8% of the children. Most children with rotavirus gastroenteritis (80.7%) were younger than two years of age. Marked seasonality of rotavirus gastroenteritis was observed, with a peak incidence from January to March. A total of 91% of rotavirus strains that were typed were of serotypes G 1-4. There was no significant difference among rotavirus-positive and rotavirus-negative patients with regard to family income. Compared with children who were exclusively breast-fed, those who were not exclusively breast-fed were at a two-fold greater risk of rotavirus diarrhea. Rotavirus gastroenteritis was significantly more severe than non-rotavirus gastroenteritis; 69% of children with rotavirus infection had severe gastroenteritis (score > or = 11). In conclusion, rotavirus is the most common cause of severe gastroenteritis among children under five years of age in Izmir. A new potent rotavirus vaccine, when available, will provide effective protection against severe rotavirus infection. Promotion of breast-feeding would augment the impact of rotavirus vaccines in preventing severe childhood diarrhea.     

A trial in the Karelian Republic of oral rehydration and Lactobacillus GG for treatment of acute diarrhoea

In a controlled trial in Petrozavodsk, Karelia, the effects of oral rehydration and Lactobacillus strain GG (LGG) on recovery from acute diarrhoea (27% rotavirus, 21% bacterial aetiology) were studied in 123 children aged between 1 and 36 months of age. On admission to hospital, the patients were first randomized to receive either isotonic oral rehydration solution (ORS) with osmolality 311mosmol/l and sodium 90mmol/l (WHO-ORS), or a hypotonic ORS with osmolality 224mosmol/l and sodium 60mmol/l (Light-ORS), and thereafter randomized to receive either 5 × 10⁹ colony forming units of LGG or a matching placebo. The two ORS performed equally for acute rehydration, and oral rehydration with either ORS was associated with a shorter duration of diarrhoea than intravenous rehydration ( p = 0.036). Patients receiving LGG had a significantly shorter duration of watery diarrhoea [mean (SD) 2.7 (2.2) days] than those receiving the placebo [3.7 (2.8) days, p = 0.03]. LGG significantly shortened the duration of rotavirus diarrhoea but not diarrhoea with confirmed bacterial aetiology.     

Risk factors associated with nosocomial rotavirus infection

A prospective study of hospital-acquired rotavirus infection was undertaken on an infant and young toddler floor to assess the incidence of infection and risk factors associated with nosocomial transmission. During the seven-month study period, gastroenteritis accounted for 60 of 663 admissions, 23 (38%) of which were due to rotavirus. In spite of enteric isolation of 21 (91%) of 23 patients with community-acquired cases, 36 infants developed nosocomial rotavirus infections. The attack rate of hospital-acquired infection was 12.8%, ranging each month from 2% to 21%. Approximately three fourths of both community-acquired cases (17/23) and nosocomial cases (27/36) occurred during the late winter and early spring. Prolonged stays in the hospital were associated with an increased attack rate of rotavirus infection. The risk of nosocomial rotavirus infection was not significantly enhanced by room contact with a rotavirus-infected patient or by the sharing of staff. However, only 47% (17/36) of patients with nosocomial infections were appropriately isolated, despite symptoms of gastroenteritis in all cases. These findings indicate that hospital acquisition of rotavirus is common, and indicate that failure to isolate patients with nosocomial rotavirus infections could be an important factor in hospital transmission.     

Safety and immunogenicity of tetravalent rhesus-based rotavirus vaccine in Bangladesh.

BACKGROUND: Rotavirus is the most common cause of severe gastroenteritis among children worldwide. OBJECTIVES: To compare the safety, immunogenicity and shedding patterns of rhesus rotavirus (RRV)-tetravalent vaccine vs. placebo among infants in rural Bangladesh. METHODS: A double blinded, placebo-controlled trial was conducted in which infants (n = 120) were randomly assigned to receive three doses of either vaccine or placebo administered at approximately 6, 10 and 14 weeks of age together with routine immunizations. Data on possible adverse effects of vaccinations were collected daily for 7 days after each dose. Stool samples were collected after each dose, and serum samples were obtained before the first and after the third vaccination. RESULTS: Fever (> or = 38 degrees C), as measured by study assistants, was noted more frequently among vaccinees (15%) than among placebo recipients (2%) during the 7 days after vaccination but was not reported more frequently by parents of vaccinees vs. placebo recipients. Overall 87% of vaccinees had an antibody response (measured by IgA or anti-RRV-neutralizing antibodies) after vaccination compared with 32% of placebo recipients. Rates of seroconversion were higher among subjects with lower levels of prevaccination antibodies and those who shed rotavirus after vaccination. Vaccine strain viruses were detected in stools from placebo vaccine recipients who had evidence of IgA seroconversion. CONCLUSIONS: In this population RRV-tetravalent vaccine was comparably immunogenic and safe as in trials conducted in developed countries, where this vaccine has been proved effective in preventing severe rotavirus diarrhea. These data support continued evaluation of rotavirus vaccines in developing countries.     

Enteric adenovirus infection and childhood diarrhea: an epidemiologic study in three clinical settings

During a 2-year prospective study of gastroenteritis in children less than 2 years of age, the role of enteric adenovirus as a cause of infantile diarrhea was examined in three clinical settings in a case-control fashion. Using a monoclonal antibody-based enzyme-linked immunosorbent assay with specificity for adenovirus serotypes 40 and 41, enteric adenovirus was identified in 10 of 246 episodes of diarrhea in outpatients (4.1%), 13 of 211 children admitted to the hospital with diarrhea (6.2%), and 5 of 81 children in whom nosocomial diarrhea developed (6.2%), making this agent the third most commonly identified etiologic agent of diarrheal disease. Asymptomatic infections were uncommon (5 of 372 control subjects, or 1.3%) and were seen most frequently in the nosocomial setting. Cases occurred in every calendar month except March and April of each year. A syndrome of watery diarrhea of longer duration compared with other patients with diarrhea (mean 5.4 vs 3.8 days, P = .01), associated with vomiting and dehydration, was present in most cases. Compared with patients with rotavirus, patients were as likely to experience fever and dehydration and more likely to vomit. Household contact with gastroenteritis, often with a child 2 to 5 years of age, was a predisposing factor. It was concluded that enteric adenovirus is an important cause of infantile diarrhea in Baltimore children. Although far less common than rotavirus, this agent was associated with diarrheal illnesses that were at least as severe as those seen with rotavirus.