Abstract:
:The AV7909 vaccine, consists of the Anthrax Vaccine Adsorbed (AVA) bulk drug substance and the immunostimulatory Toll-like receptor 9 agonist oligodeoxynucleotide adjuvant CPG 7909. The purpose of this research was to evaluate the potential maternal, reproductive, and developmental toxicity of AV7909 in rats to support licensure for use in women of childbearing potential. Groups of first generation (F0 ) female Sprague Dawley rats were dosed by intramuscular injection with water for injection, adjuvant or AV7909 at a volume of 0.5 ml/dose. Each rat received three vaccinations: 14 days prior to start of the mating period, on the first day of the mating period and on gestation day (GD) 7. There was no maternal mortality. Body weights, weight gain, and food consumption were comparable between groups. Findings in F0 females were limited to transient injection site edema and nodules consistent with immunostimulatory effects of the vaccine and adjuvant. Administration of AV7909 did not affect mating, fertility, pregnancy, embryo-fetal viability, growth, or morphologic development, parturition, maternal care of offspring or postnatal survival, growth, or development. There was no evidence of systemic inflammation in pregnant rats, based on evaluation of serum concentrations of the acute phase proteins alpha-2-macroglobulin and alpha-1-acid glycoprotein on GD 21. Anthrax lethal toxin-neutralizing antibodies were detected in AV7909-vaccinated F0 females. The antibodies were also detected in the sera of fetuses and F1 pups. Exposure of the fetuses and pups to maternally derived anthrax lethal toxin-neutralizing antibodies was not associated with developmental toxicity.
journal_name
Birth Defects Resjournal_title
Birth defects researchauthors
Mylchreest E,Smiley MA,Ballin JD,Blauth B,Shearer J,Reece J,Ionin B,Savransky Vdoi
10.1002/bdr2.1815subject
Has Abstractpub_date
2021-01-01 00:00:00pages
32-42issue
1issn
2472-1727journal_volume
113pub_type
杂志文章abstract::OEIS is the acronym of a malformations complex association including omphalocele, exstrophy of bladder or cloaca, imperforate anus, and spinal defects. It has a very low prevalence, ranging from 1/82,000 to 1/200,000 live births (LB). The etiology of OEIS is unknown. Virtually all cases are sporadic, and specific asso...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1512
更新日期:2019-07-01 00:00:00
abstract:BACKGROUND:Cardiac fibrosis is a cardinal feature of multiple types of cardiovascular disease, which lead to heart failure. Multiple studies connect adverse maternal environment (AME) with cardiac fibrosis. AME does not always result in fibrosis, though. An additional "insult", such as an adult Western diet (WD), is fr...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1428
更新日期:2018-12-01 00:00:00
abstract::As a result of human socio-economic activity, industrial wastes have increased alarmingly. Plastic pollution is globally distributed across the world due to its properties of buoyancy and durability. Two broad classes of plastic-related chemicals are of critical concern for human health-bisphenol-A or BPA, and additiv...
journal_title:Birth defects research
pub_type: 杂志文章,评审
doi:10.1002/bdr2.1776
更新日期:2020-10-01 00:00:00
abstract::In 2016, Centers for Disease Control and Prevention (CDC) established surveillance of pregnant women with Zika virus infection and their infants in the U.S. states, territories, and freely associated states. To identify cases of Zika-associated birth defects, subject matter experts review data reported from medical re...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1767
更新日期:2020-11-01 00:00:00
abstract:OBJECTIVE:Assess temporal trends in congenital microcephaly. METHODS:We used Texas inpatient discharge diagnoses between 2000 and 2015, restricting to newborns. Between 2000 and 2003, the maximum number of fields for recording diagnostic codes was eight, and between 2004 and 2015 it was 24. Microcephaly was classified...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1491
更新日期:2019-06-01 00:00:00
abstract::Zika virus was first identified in Uganda in 1947 but received little attention until 2015 when a large outbreak of Zika virus illness followed by an increased number of babies born with microcephaly occurred in Brazil. Zika virus spread rapidly throughout the Americas, and in 2016 was identified as a cause of microce...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1781
更新日期:2020-09-01 00:00:00
abstract::The blood-brain barrier (BBB) serves as a gateway for passage of drugs, chemicals, nutrients, metabolites, and hormones between vascular and neural compartments in the brain. Here, we review BBB development with regard to the microphysiology of the neurovascular unit (NVU) and the impact of BBB disruption on brain dev...
journal_title:Birth defects research
pub_type: 杂志文章,评审
doi:10.1002/bdr2.1180
更新日期:2017-12-01 00:00:00
abstract:BACKGROUND:The acronym VATER/VACTERL refers to the rare nonrandom association of the following component features (CF): vertebral defects (V), anorectal malformations (A), cardiac defects (C), tracheoesophageal fistula with or without esophageal atresia, renal malformations (R), and limb defects (L). Patients presentin...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1042
更新日期:2017-07-17 00:00:00
abstract:OBJECTIVES:Strategies for conducting juvenile dose ranging studies before definitive toxicity juvenile animal studies (JAS) have evolved, but the aim of demonstrating study design robustness and efficient animal use remains the same. The objective of dose selection is to identify a strategy to achieve consistent system...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1856
更新日期:2020-12-14 00:00:00
abstract:BACKGROUND:Despite the numerous reports on the limb body wall complex (LBWC), this association has never been adequately defined. Amniotic bands (AB) are frequently present but their role remains unclear. Since most reports were based on clinical and often subjective diagnoses, the aim of this work was to define LBWC a...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1442
更新日期:2019-03-01 00:00:00
abstract::Antibody-like biopharmaceuticals cross the placenta by utilizing existing transport pathways (e.g., FcRn receptor). There are limited data evaluating this transfer during organogenesis in any species. Understanding placental transfer of antibody-like biopharmaceuticals can help to predict risk of developmental toxicit...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1615
更新日期:2020-01-01 00:00:00
abstract::The World Health Organization currently recommends quinine+clindamycin for use against malaria in the first trimester. This may soon change to recommending artemisinin-based combination therapies (standard duration of dosing = 3 days). The non-artemisinin partner drugs include amodiaquine, lumefantrine, mefloquine, pi...
journal_title:Birth defects research
pub_type: 杂志文章,评审
doi:10.1002/bdr2.1035
更新日期:2017-08-15 00:00:00
abstract:BACKGROUND:During the Zika virus (ZIKV) outbreak, an urgent need existed for strong partnerships to disseminate Zika-related information to pregnant women and women of child-bearing age. METHODS:The Centers for Disease Control and Prevention (CDC) partnered with MotherToBaby, a national organization experienced in pro...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1787
更新日期:2020-11-01 00:00:00
abstract::Cytomegalovirus (CMV) is a DNA herpesvirus that is common worldwide. The two known main sources of primary CMV infection during pregnancy are through sexual activity and contact with young children. Primary infection occurs in approximately 1 to 4% of pregnancies, and is mostly asymptomatic in immunocompetent adults. ...
journal_title:Birth defects research
pub_type: 杂志文章,评审
doi:10.1002/bdra.23601
更新日期:2017-03-15 00:00:00
abstract:BACKGROUND:The tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine is recommended during pregnancy to protect newborns against pertussis infection in the months prior to their primary pertussis vaccination. Although research on the safety of the vaccine has been reassuring, most previous s...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1642
更新日期:2020-03-01 00:00:00
abstract:BACKGROUND:With the increasing birth prevalence of hypospadias, there is growing concern for pollutant exposure interfering with normal penile development. We assess the association between hypospadias and hormonally active hazardous air pollutants (HAHAPs) through a nationwide database of hazardous air pollutants and ...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1461
更新日期:2019-04-15 00:00:00
abstract:BACKGROUND:There is considerable variability in the prevalence of birth defects among racial/ethnic groups. This study estimated birth defect prevalence among the less studied non-Hispanic (NH) Asian/Pacific Islander (PI) and American Indian/Alaska Native (AI/AN) populations in Texas relative to NH Whites. METHODS:Dat...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1543
更新日期:2019-11-01 00:00:00
abstract::Neonatal cataracts remain the most common cause of visual loss in children worldwide and have diverse, often unknown, etiologies. This review summarizes current knowledge about the detection, treatment, genetics, risk factors, and molecular mechanisms of congenital cataracts. We emphasize significant progress and topi...
journal_title:Birth defects research
pub_type: 杂志文章,评审
doi:10.1002/bdr2.1050
更新日期:2017-06-01 00:00:00
abstract:OBJECTIVES:To explore the technical aspects and clinical utility of early fetal echocardiography and screening of the fetal heart in early pregnancy. Also, to document differences in cardiac structure and function which can be demonstrated in the late first/early second trimesters. METHODS:In addition to summarizing o...
journal_title:Birth defects research
pub_type: 杂志文章,评审
doi:10.1002/bdr2.1414
更新日期:2019-05-01 00:00:00
abstract:BACKGROUND:Antecedents for infantile hypertrophic pyloric stenosis (IHPS) vary across studies; therefore, we conducted a multistate, population-based retrospective study of the prevalence and descriptive epidemiology of IHPS in the United States (US). METHODS:Data for IHPS cases (n = 29,554) delivered from 1999-2010 a...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1439
更新日期:2019-02-01 00:00:00
abstract::Birth defects are the leading cause of infant death in the United States and among the top causes of pediatric death and hospitalization. Despite the devastating impact of birth defects, we understand little of their etiology impeding progress towards treatment and prevention. Moreover, while surgical interventions ha...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdra.23590
更新日期:2017-01-30 00:00:00
abstract:BACKGROUND:It is estimated that 20 to 30% of infants with birth defects have two or more birth defects. Among these infants with multiple congenital anomalies (MCA), co-occurring anomalies may represent either chance (i.e., unrelated etiologies) or pathogenically associated patterns of anomalies. While some MCA pattern...
journal_title:Birth defects research
pub_type: 杂志文章,评审
doi:10.1002/bdr2.1115
更新日期:2018-01-15 00:00:00
abstract:BACKGROUND:Hypoplastic right heart syndrome (HRHS) is a rare congenital defect characterized by underdevelopment of the right heart structures commonly accompanied by an atrial septal defect. Familial HRHS reports suggest genetic factor involvement. We examined the role of copy number variants (CNVs) in HRHS. METHODS:...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdra.23586
更新日期:2017-01-20 00:00:00
abstract:BACKGROUND:As a result of human socioeconomic activity, industrial wastes have increased distressingly. Plastic pollution is globally distributed across the world due to its properties of buoyancy and durability. A big health hazard is the sorption of toxicants to plastic while traveling through the environment. Two br...
journal_title:Birth defects research
pub_type: 杂志文章,评审
doi:10.1002/bdr2.1779
更新日期:2020-10-01 00:00:00
abstract:BACKGROUND:Obstetricians usually prescribe supplements during pregnancy without actual indication. The use of selenium during pregnancy has increased, due to its function in several antioxidant mechanisms. CASE:A pregnant woman received 200,000 micrograms (μg) per day of a selenium galenic formulation, since gestation...
journal_title:Birth defects research
pub_type: 杂志文章,评审
doi:10.1002/bdr2.1148
更新日期:2018-03-01 00:00:00
abstract:BACKGROUND:The different mechanisms leading to a solitary kidney should be differentiated because the long-term outcome might be different. The fetal period is the best moment to make a true diagnosis of congenital unilateral renal agenesis (URA). The objective was to determine the prevalence of URA at birth. The secon...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1065
更新日期:2017-09-01 00:00:00
abstract:BACKGROUND:Many therapies to treat cancer are gonadotoxic and can lead to infertility. New strategies to diminish the side effects and protective plans during and after chemotherapy are needed. Therefore, bone marrow mesenchymal stem cells (BM-MSCs) as a novel solution were investigated against doxorubicin (Dox)-induce...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1535
更新日期:2019-08-01 00:00:00
abstract:BACKGROUND:Maternal smoking or passive smoking during gestation increases the risk of congenital birth defects, including neural tube defects (NTDs). Cigarette smoke is a recognized teratogen that causes NTDs, although the mechanisms are not well understood. METHODS:An established model of passive smoking in pregnant ...
journal_title:Birth defects research
pub_type: 杂志文章
doi:10.1002/bdr2.1804
更新日期:2021-01-01 00:00:00
abstract::Mouse models are invaluable for investigating the developmental etiology and molecular pathogenesis of structural birth defects. While this has been deployed for studying a wide spectrum of birth defects, mice are particularly valuable for modeling congenital heart disease, given they have the same four-chamber cardia...
journal_title:Birth defects research
pub_type: 杂志文章,评审
doi:10.1002/bdr2.1048
更新日期:2017-06-01 00:00:00
abstract::Cannabis use during adolescence has been linked to deleterious effects on brain integrity. This article summarizes findings from two prospective investigations (3 and 6 years, on average) on adolescent cannabis use from our laboratory that utilize structural neuroimaging and neurocognitive assessment approaches. Acros...
journal_title:Birth defects research
pub_type: 杂志文章,评审
doi:10.1002/bdr2.1572
更新日期:2019-10-15 00:00:00