Congenital Malformations in the Newborn Population: A Population Study and Analysis of the Effect of Sex and Prematurity

Egbe, Alexander C.; Uppu, Santosh C.; Lee, Simon; Stroustrup, Annemarie; Ho, Deborah; Srivastava, Shubhika

doi:10.1016/j.pedneo.2014.03.010

Cited by 62 publications

(57 citation statements)

References 20 publications

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“…Although a direct comparison was difficult, rates of pregnancy outcomes observed in this trial were found to be close to the reported rates available in the literature. [31][32][33][34][35] These observations are in line with results from pooled analyses and post-marketing studies conducted so far to assess pregnancy outcomes after exposure to AS04-HPV-16/18 vaccine. [36][37][38][39] The study has some limitations.…”

Section: Discussionsupporting

confidence: 77%

“…Among them, 138 (92%) were seronegative for anti-HPV-31 antibodies and 141 (94%) were seronegative for anti-HPV-45 antibodies at the baseline. All of those who were seronegative for the type analyzed at baseline had seroconverted for HPV- 31 significantly different as the 95% CIs were largely overlapping for both anti-HPV-31 and -45.…”

Section: Serum Antibody Response Against Hpv-31 and Hpv-45mentioning

confidence: 98%

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A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years

Schwarz

Huang

Valencia

et al. 2019

Human Vaccines & Immunotherapeutics

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This study assessed long-term immunogenicity and safety following 3 doses of AS04-adjuvanted human papillomavirus (HPV)-16/18 L1 virus-like particle (VLP) vaccine in females 10-14 years old. Girls included in the immunogenicity subset in the primary controlled, observer-blinded, randomized study (NCT00196924) who received 3 doses were invited for a 10-year follow-up (NCT00316706 and NCT00877877). Serum antibody responses against HPV-16/18 (vaccine types) and HPV-31/45 (nonvaccine types) were measured by enzyme-linked immunosorbent assay (ELISA) using type-specific VLP as coating antigens. Serious adverse events (SAEs) and pregnancy information were recorded. At Month (M) 120, all subjects (N = 418, according-to-protocol immunogenicity cohort) were seropositive for anti-HPV-16/18 antibodies. Geometric mean titers (GMTs) were 1589.9 ELISA Units [EU]/mL (95% confidence interval [CI]: 1459.8-1731.6) for anti-HPV-16 and 597.2 EU/mL (95% CI: 541.7-658.5) for anti-HPV-18 in subjects seronegative at baseline for the type analyzed. Post hoc mathematical modeling predicted a durability ≥50 years for anti-HPV-16 and anti-HPV-18. For the non-vaccine humoral type response, all initially seronegative subjects had seroconverted at M7, with anti-HPV-31 GMT of 2030.5 EU/mL (95% CI: 1766.2-2334.4) and anti-HPV-45 GMT of 2300.8 EU/mL (95% CI: 2036.8-2599.0). At M120, 87.7% and 85.1% remained seropositive for anti-HPV-31 with GMT of 242.9 EU/mL (95% CI: 201.4-293.0) and anti-HPV-45 with GMT of 204.7 EU/mL (95% CI: 170.0-246.6). During the 10-year follow-up, no SAEs or abnormal pregnancy outcomes were causally related to vaccination. Three doses of the AS04-HPV-16/18 vaccine induced high and sustained antibody response against HPV-16,18,31 and 45 in girls aged 10-14 years during the 10-year follow-up, with an acceptable long-term safety profile.

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Section: Discussionsupporting

confidence: 77%

Section: Serum Antibody Response Against Hpv-31 and Hpv-45mentioning

confidence: 98%

A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years

Schwarz

Huang

Valencia

et al. 2019

Human Vaccines & Immunotherapeutics

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“…Congenital anomalies are among the major causes of infant death worldwide (Brazilian Ministry of Health, MoH) (Egbe et al , 2015). In the United States, as in other high-income countries, birth defects are the main cause of infant mortality, being responsible for 1 out of 5 infant deaths (Petrini et al , 2002).…”

Section: Introductionmentioning

confidence: 99%

“…Within the main causes of infant deaths in the United States, congenital malformations, deformations and chromosomal abnormalities appear in first place, representing 20.3% of total infant deaths in 2013 (Xu et al , 2016). These are also the reasons for 12% of all pediatric hospitalizations (Egbe et al , 2015). In Latin America, congenital anomalies are between the second and fifth cause of death in children under 1 year of age (Bronberg et al.…”

Section: Introductionmentioning

confidence: 99%

Teratogens: a public health issue – a Brazilian overview

et al. 2017

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Congenital anomalies are already the second cause of infant mortality in Brazil, as in many other middle-income countries in Latin America. Birth defects are a result of both genetic and environmental factors, but a multifactorial etiology has been more frequently observed. Here, we address the environmental causes of birth defects – or teratogens – as a public health issue and present their mechanisms of action, categories and their respective maternal-fetal deleterious effects. We also present a survey from 2008 to 2013 of Brazilian cases involving congenital anomalies (annual average of 20,205), fetal deaths (annual average of 1,530), infant hospitalizations (annual average of 82,452), number of deaths of hospitalized infants (annual average of 2,175), and the average cost of hospitalizations (annual cost of $7,758). Moreover, we report on Brazilian cases of teratogenesis due to the recent Zika virus infection, and to the use of misoprostol, thalidomide, alcohol and illicit drugs. Special attention has been given to the Zika virus infection, now proven to be responsible for the microcephaly outbreak in Brazil, with 8,039 cases under investigation (from October 2015 to June 2016). From those cases, 1,616 were confirmed and 324 deaths occurred due to microcephaly complications or alterations on the central nervous system. Congenital anomalies impact life quality and raise costs in specialized care, justifying the classification of teratogens as a public health issue.

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“…Congenital anomalies (CAs) are the leading cause of death and morbidity in children. 1 An appropriate detection and prompt treatment are essential to reduce complications in these children. Multiple approaches have been made to better identify and study CAs.…”

Section: Introductionmentioning

confidence: 99%

Social and Clinical Impact of Congenital Urological Malformations in a Developing Country: The Need for a Transdisciplinary Way of Treatment

et al. 2018

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Introduction The prognosis of congenital anomalies (CAs) can be improved if detected and treated accurately. Given the complexity of some anomalies, it is almost always necessary to approach them with an interdisciplinary team. Our objective was to contact patients with congenital urological anomalies (CUAs) and follow them up during their first years of life and evaluate their clinical status, as well as their social and health care limitations. Method Based on the Bogota Congenital Malformations Surveillance Program (BCMSP), we have contacted by phone all the patients with CUAs and evaluated their follow-up. We have included all the registered patients from 2006 until 2015. A standardized questionnaire was applied by a trained staff. The questions assessed on each call included: evaluation of the clinical status of the patient, the clinical treatments and evaluations performed by clinical and surgical subspecialties, health care limitations, and social barriers. The first call was made at the 2nd month, then every 3 months during the 1st year and every 6 months thereafter. Results A total of 277 patients were contacted, 97.3% of whom have an increased risk of mortality or significant disability. The malformation related mortality was of 38.1%. Only 38.7% of the patients were evaluated by a specialist, while 57.4% where still waiting to be seen by a specialist. Ninety eight percent of the limitations related to the health care system were the long waiting lists to be seen by a specialist. Conclusion Many of the pathologies that we have found belong to the group that has a significant reduction in mortality when treated accurately and promptly. However, we have a profound problem in our health care system, in that many of the patients have not been seen by a specialist, which results in a worse prognosis and recovery rate.

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Congenital Malformations in the Newborn Population: A Population Study and Analysis of the Effect of Sex and Prematurity

Cited by 62 publications

References 20 publications

A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years

A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years

Teratogens: a public health issue – a Brazilian overview

Social and Clinical Impact of Congenital Urological Malformations in a Developing Country: The Need for a Transdisciplinary Way of Treatment

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