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M Lourdes Guerrero

Publications and source records attributed to M Lourdes Guerrero.

9 recordsLinked to original sources
PubMed2006

Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis.

BACKGROUND: The safety and efficacy of an attenuated G1P[8] human rotavirus (HRV) vaccine were tested in a randomized, double-blind, phase 3 trial. METHODS: We studied 63,225 healthy infants from 11 Latin American countries and Finland who received two oral doses of either the HRV vaccine (31,673 infants) or placebo (31,552 infants) at approximately two months and four months of age. Severe gastroenteritis episodes were identified by active surveillance. The severity of disease was graded with the use of the 20-point Vesikari scale. Vaccine efficacy was evaluated in a subgroup of 20,169 infants (10,159 vaccinees and 10,010 placebo recipients). RESULTS: The efficacy of the vaccine against severe rotavirus gastroenteritis and against rotavirus-associated hospitalization was 85 percent (P<0.001 for the comparison with placebo) and reached 100 percent against more severe rotavirus gastroenteritis. Hospitalization for diarrhea of any cause was reduced by 42 percent (95 percent confidence interval, 29 to 53 percent; P<0.001). During the 31-day window after each dose, six vaccine recipients and seven placebo recipients had definite intussusception (difference in risk, -0.32 per 10,000 infants; 95 percent confidence interval, -2.91 to 2.18; P=0.78). CONCLUSIONS: Two oral doses of the live attenuated G1P[8] HRV vaccine were highly efficacious in protecting infants against severe rotavirus gastroenteritis, significantly reduced the rate of severe gastroenteritis from any cause, and were not associated with an increased risk of intussusception. (ClinicalTrials.gov numbers, NCT00139347 and NCT00263666.)

Administration, Oral↗
PubMed2006

Risk of infant anemia is associated with exclusive breast-feeding and maternal anemia in a Mexican cohort.

The WHO recommends exclusive breast-feeding (EBF) for the first 6 mo of life to decrease the burden of infectious disease. However, some are concerned about the effect of EBF >6 mo on iron status of children in developing countries in which anemia is prevalent. This study examines the risk of anemia in relation to the duration of EBF and maternal anemia in a birth cohort studied between March 1998 and April 2003. All infant birth weights were >or=2.2 kg. All mothers received home-based peer counseling to promote EBF. Infant feeding data were collected weekly. Nurses measured hemoglobin (Hb) values every 3 mo. Hb was measured in 183 infants at 9 mo of age. Anemia at 9 mo was defined as a Hb value <100 g/L. EBF was defined by WHO criteria and ranged in duration from 0 to 31 wk. At 9 mo, Hb (mean +/- SEM) was 114 +/- 0.9 g/L; 23 children (12.5%) had Hb levels <100 g/L. EBF >6 mo, but not EBF 4-6 mo, was associated with increased risk of infant anemia compared with EBF <4 mo (odds ratio=18.4, 95% CI=1.9, 174.0). Maternal anemia was independently (P=0.03) associated with a 3-fold increased risk of infant anemia. These associations were not explained by confounding with other maternal or infant factors. By linear regression, a lower infant Hb at 9 mo was associated with increased EBF duration among mothers who had a history of anemia (beta=-0.07, P=0.003), but not among mothers with no history of anemia. Infants who are exclusively breast-fed for >6 mo in developing countries may be at increased risk of anemia, especially among mothers with a poor iron status; greater attention to this issue is warranted.

Anemia↗
PubMed2005

Evaluation of safety, immunogenicity and efficacy of an attenuated rotavirus vaccine, RIX4414: A randomized, placebo-controlled trial in Latin American infants.

BACKGROUND: A live attenuated monovalent rotavirus vaccine RIX4414 was developed with a human strain of G1P1A P[8] specificity to reduce the rotavirus burden in children. METHODS: A double blind, randomized, placebo-controlled study evaluated the efficacy, immunogenicity, safety and reactogenicity of 2 oral doses of RIX4414 (10(4.7), 10(5.2) or 10(5.8) focus-forming units) at 2 and 4 months coadministered with routine vaccinations and oral poliovirus vaccine given for study purposes at least 14 days apart. The 2155 infants (1618 vaccine/537 placebo) enrolled in Brazil, Mexico and Venezuela were followed until 1 year of age. RESULTS: Antirotavirus IgA seroconversion rates 2 months after dose 2 ranged between 61% (10(4.7) ffu group) and 65% (10(5.8) ffu group), and most of the infants had seroprotective levels of antibodies to coadministered routine vaccinations. The reactogenicity profile of RIX4414 was similar to that of the placebo, and no vaccination-related serious adverse events were reported. Protective efficacy against severe and any rotavirus gastroenteritis from 15 days post-dose 2 was highest in the 10(5.8) ffu group [86%; 95% confidence interval (95% CI), 63-96% and 70% (95% CI 46-84%), P < 0.001, 2-sided Fisher's exact test]. The efficacy against hospitalization was 79% (95% CI 48-92%) for pooled vaccine groups. Multiple rotavirus serotypes [G1 (50%), G9 (40%), G2, G3 and G4] were identified from gastroenteritis stools (enzyme-linked immunosorbent assay and reverse transcription-polymerase chain reaction) during the study period. For severe gastroenteritis caused by G9 serotypes, the protection reached 77% (95% CI 18-96%) in the 10(5.8) ffu group, providing proof of concept that the monovalent G1P1A P[8] human rotavirus vaccine elicits cross-protection against the G9 strain. A reduction in any and severe rotavirus gastroenteritis was already observed at post-dose 1 (period: day of dose 1 to 14 days post-dose 2) in vaccinees compared with placebo recipients. CONCLUSIONS: Two doses of RIX4414 are highly efficacious, providing cross-protection (G1 and G9 strains, prevalent during this study) and early protection against any and severe rotavirus gastroenteritis and hospitalization to infants in Latin America.

Administration, Oral↗
PubMed2004

Human milk oligosaccharides are associated with protection against diarrhea in breast-fed infants.

OBJECTIVE: To determine the association between maternal milk levels of 2-linked fucosylated oligosaccharide and prevention of diarrhea as a result of Campylobacter, caliciviruses, and diarrhea of all causes in breast-fed infants. STUDY DESIGN: Data and banked samples were analyzed from 93 breast-feeding mother-infant pairs who were prospectively studied during 1988-1991 from birth to 2 years with infant feeding and diarrhea data collected weekly; diarrhea was diagnosed by a study physician. Milk samples obtained 1 to 5 weeks postpartum were analyzed for oligosaccharide content. Data were analyzed by Poisson regression. RESULTS: Total 2-linked fucosyloligosaccharide in maternal milk ranged from 0.8 to 20.8 mmol/L (50%-92% of milk oligosaccharide). Moderate-to-severe diarrhea of all causes (n=77 cases) occurred less often (P=.001) in infants whose milk contained high levels of total 2-linked fucosyloligosaccharide as a percent of milk oligosaccharide. Campylobacter diarrhea (n=31 cases) occurred less often (P=.004) in infants whose mother's milk contained high levels of 2'-FL, a specific 2-linked fucosyloligosaccharide, and calicivirus diarrhea (n=16 cases) occurred less often (P=.012) in infants whose mother's milk contained high levels of lacto-N-difucohexaose (LDFH-I), another 2-linked fucosyloligosaccharide. CONCLUSION: This study provides novel evidence suggesting that human milk oligosaccharides are clinically relevant to protection against infant diarrhea.

Adolescent↗
PubMed2004

Epidemiology of breastfeeding: advances and multidisciplinary applications.

Advancing understanding of the importance of breastfeeding (BF) has required advances in application of epidemiologic methods to BF research. This chapter considers, in the context of BF epidemiology, how different research designs complement each other to establish firmer causal inferences, the need for multidisciplinary collaborations, and the application of powerful analytical methods to strengthen epidemiologic studies. A recent global meta-analysis of 47 studies documenting the inverse association between lifetime BF duration and breast cancer risk illustrates the value of longitudinal (cohort) studies to establish the temporal sequence of events and to rule out differential recall biases that can threaten the internal validity of case-control studies. The discovery of the transmission of human immunodeficiency virus (HIV) via human milk has led epidemiologists to provide important hypotheses to be tested at the molecular and cellular level and in turn test hypotheses generated in laboratory studies. Application of powerful statistical methods to BF epidemiology has helped strengthen causal inferences. A retrospective analysis of the 1976--1977 Malaysian Family Life Survey found interactive multivariate statistical models to better understand how different socioeconomic and cultural contexts modify the influence of BF on child health. Further, a study conducted in Cebu City, Philippines, demonstrated how structural equation models can be used to test the pathways through which proximate (e.g., BF) and distal (e.g., socioeconomic status) determinants affect child health after adjusting for reverse causality (i.e., child health influencing maternal BF choice). For ethical reasons, BF randomized controlled trials (RCTs) have seldom been conducted. Recent RCTs examining the link between BF peer counseling and BF outcomes in diverse settings provides a unique opportunity to firmly establish the causal inferences regarding BF and the prevention of diarrheal diseases. The value of rapid assessment anthropologic methods to guide development of peer counseling interventions subsequently tested through RCTs is presented. This chapter also illustrates how Cox regression and logistic regression can be applied to BF research.

Breast Feeding↗
PubMed2003

Human milk secretory antibodies against attaching and effacing Escherichia coli antigens.

Secretory immunoglobulin A (sIgA) is a primary factor responsible for preventing attachment of enteropathogens to gut epithelium in breastfeeding infants. We compared the frequency of sIgA to major surface antigens of enterohemorrhagic Escherichia coli (EHEC) in milk of 123 women from the United States and Mexico to determine whether regional differences existed in the frequency of antibodies to these surface antigens. In both groups of women, milk commonly has sIgA against various EHEC lipopolysaccharides, EspA, EspB, intimin, and less frequently against Shiga toxin. The study suggests that persons living in the United States are exposed to attaching/effacing enteropathogens more frequently than is generally assumed. The low frequency of antibodies to Stx1 (in 12% of Mexican and in 22% of U.S. samples) suggests that the rare appearance of hemolytic uremic syndrome in adults is not due to neutralization of toxin at the gut level. Only anti-EspA is found in most milk samples from both populations of women. EspA may represent a useful target for an immunization strategy to prevent EHEC disease in humans.

Adult↗
PubMed1993

Cohort study of rotavirus serotype patterns in symptomatic and asymptomatic infections in Mexican children.

A cohort of 200 Mexican children from a low income periurban community was monitored from birth to the age of 2 years to determine the serotype-specific incidence, morbidity and seasonal pattern of symptomatic and asymptomatic human rotavirus (HRV) infections. A total of 177 HRV infections occurred in 134 (67%) children; 50% of these infections were asymptomatic. The incidence of all HRV infections was 0.6 episode/child year and was inversely related to age (r = -0.93; P < 0.01). The incidence of HRV-associated diarrhea was 0.3 episode/child year, with the highest frequency and severity occurring in infants between 4 and 6 months of age. HRV infections were more frequent each autumn, with a changing sequential pattern of predominant serotypes. Overall serotype 3 (34%) was the most frequent, followed by serotypes 1 (16%), 2 (15%) and 4 (6%). The 4 serotypes were associated with a similar risk for diarrhea and severity of diarrhea. In 23 (26%) HRV diarrhea-associated infections, an additional enteropathogen was identified; these mixed infections were more frequent in older children (chi square, 4.45; P < 0.05) but were not more severe (chi square, 0.02; P > 0.05). Our data indicate that HRV infections were common early in life, seasonal, frequently asymptomatic and caused by a variety of serotypes, none of which was a risk factor for diarrhea or severity of diarrhea.

Cohort Studies↗