RSV Prefusion F Protein–Based Maternal Vaccine — Preterm Birth and Other Outcomes

New England Journal of Medicine, Год журнала: 2024, Номер 390(11), С. 1009 - 1021

Опубликована: Март 13, 2024

BackgroundVaccination against respiratory syncytial virus (RSV) during pregnancy may protect infants from RSV disease. Efficacy and safety data on a candidate prefusion F protein–based maternal vaccine (RSVPreF3-Mat) are needed.MethodsWe conducted phase 3 trial involving pregnant women 18 to 49 years of age assess the efficacy RSVPreF3-Mat. The were randomly assigned in 2:1 ratio receive RSVPreF3-Mat or placebo between 24 weeks 0 days 34 gestation. primary outcomes any severe medically assessed RSV-associated lower tract disease birth 6 months 12 age. After observation higher risk preterm group than group, enrollment vaccination stopped early, exploratory analyses signal performed.ResultsThe included 5328 5233 infants; target approximately 10,000 their was not reached because early. A total 3426 1711 followed age; 16 infants, respectively, had (vaccine efficacy, 65.5%; 95% credible interval, 37.5 82.0), 8 14, 69.0%; 33.0 87.6). Preterm occurred 6.8% (237 3494) 4.9% those (86 1739) (relative risk, 1.37; confidence interval [CI], 1.08 1.74; P=0.01); neonatal death 0.4% (13 0.2% (3 1739), respectively 2.16; CI, 0.62 7.56; P=0.23), an imbalance probably attributable greater percentage births group. No other observed.ConclusionsThe results this trial, which early concerns, suggest that risks among with but vaccine. (Funded by GlaxoSmithKline Biologicals; ClinicalTrials.gov number, NCT04605159.)

Язык: Английский

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Stillbirth: we can do better

American Journal of Obstetrics and Gynecology, Год журнала: 2024, Номер 231(2), С. 152 - 165

Опубликована: Май 23, 2024

Язык: Английский

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Influence of SARS-CoV-2 variants of concern and maternal vaccination status on neonatal outcome

BMJ Paediatrics Open, Год журнала: 2025, Номер 9(1), С. e003109 - e003109

Опубликована: Янв. 1, 2025

SARS-CoV-2 infection during pregnancy can adversely affect maternal and neonatal health, although risks vary depending on the variant of concern (VOC). Omicron, highly infectious, causes fewer complications than earlier VOC, so vaccination may be considered unnecessary in planned pregnancy. Using data from CRONOS registry, we compared outcomes according to VOC status. We found that reduced preterm birth rates with unvaccinated or vaccinated women Omicron infection, without increasing severe outcomes. Given associated birth, study consistently supports recommendations for planning

Язык: Английский

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Concordance of maternal and cord blood SARS-COV-2 immunoglobulin seropositivity after COVID-19 infection or vaccination in pregnancy

Journal of Neonatal-Perinatal Medicine, Год журнала: 2025, Номер unknown

Опубликована: Фев. 5, 2025

Objective To assess maternal antibody response to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection during pregnancy and subsequent transplacental transfer in cord blood. Study Design This is a prospective cohort study of Disease 2019 (COVID-19) polymerase chain reaction (PCR) positive pregnant women their newborns. SARS-CoV-2 PCR (+) were enrolled, with (−) as control. Maternal blood was obtained at enrollment collected delivery. Baseline infant characteristics neonatal outcomes collected. Samples analyzed using coronavirus antigen microarray containing immunologically significant antigens from (including nucleocapsid protein [NP], spike [S], S1, S2, receptor-binding domain [RBD]) which can detect immunoglobulin G (IgG) M (IgM). Results Thirty-seven maternal-cord paired samples for IgG or IgM antibodies; 15 out 20 14 17 mothers positive. the received COVID-19 vaccine pregnancy. Difference between seropositivity naturally infected versus vaccinated significant, 75% 100% ( p = 0.043). antibodies detected 10 but none Conclusions Excellent concordance exist Significantly higher SARS-COV-2 found mothers.

Язык: Английский

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Pregnancy and neonatal outcomes of SARS-CoV-2 infection discovered at the time of delivery: a tertiary center experience in North Italy

Journal of Perinatal Medicine, Год журнала: 2023, Номер 52(2), С. 215 - 221

Опубликована: Окт. 17, 2023

Abstract Objectives Although the knowledge on SARS-CoV-2 infection in pregnancy has greatly improved, there is still a lack of information its role later stages gestation. The aim this study to investigate whether discovered at delivery associated with any obstetric or neonatal complications. Methods A retrospective case-control was conducted Department Obstetrics, University Hospital Maggiore della Carità, Novara, Italy, from March 2020 2023. Pregnant women admitted were tested for SARS-CoV-2. 168 resulted positive time delivery; asymptomatic paucisymptomatic. 170 negative selected as controls, selecting, each patient, patient who gave birth right before, if negative. Demographic and anamnestic characteristics, pregnancy, labor, outcomes evaluated. Results patients more likely have gestational diabetes (13.7 vs. 5.3 %) required less frequently intrapartum analgesia (11.3 27 labor augmentation (7.3 16.5 %). Post-partum hemorrhage rate lower 22.9 shorter length first second stage occurred. There no statistically significant differences between two groups regarding mode outcomes. Conclusions incidence postpartum hemorrhage. Fewer interventions, well use oxytocin, could explain these findings. Moreover, increase susceptibility infection. paucisymptomatic does not appear cesarean other complications, worsened.

Язык: Английский

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Impact of Infections During Pregnancy on Transplacental Antibody Transfer

Vaccines, Год журнала: 2024, Номер 12(10), С. 1199 - 1199

Опубликована: Окт. 21, 2024

Vaccination in pregnancy is important to protect the mother and fetus from infectious diseases. The transfer of maternal antibodies across placenta during can continue neonate for several months after birth while neonatal adaptive immune system develops. Several pathogens have been shown impair transplacental antibodies, including human immunodeficiency virus, malaria, severe acute respiratory syndrome coronavirus 2, cytomegalovirus. This review discusses mechanisms contributing decreased antibody setting infections, such as changes glycosylation profile, hypergammaglobulinemia, placental injury. frequency epidemics increasing, pregnant people are more likely become exposed novel now than they were past. Understanding by which diseases maternal-fetal pandemic preparedness maximize impact vaccination child health.

Язык: Английский

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Neonatal outcomes of maternal prenatal coronavirus infection

Pediatric Research, Год журнала: 2023, Номер 95(2), С. 445 - 455

Опубликована: Дек. 6, 2023

Язык: Английский

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Covid-19 vaccine safety in pregnancy, a nested case-control study in births from April 2021 to March 2022, England

medRxiv (Cold Spring Harbor Laboratory), Год журнала: 2023, Номер unknown

Опубликована: Окт. 9, 2023

Abstract Introduction Vaccine safety in pregnancy is always of paramount importance. Current evidence COVID-19 vaccine has been reassuring with no association found negative maternal and neonatal outcomes. However, very few studies are conducted on a national level investigate dosage, timing vaccination as well manufacturer. To fill this knowledge gap, we population based evaluation England, including by trimester, dosage manufacturer received pregnancy. Method A matched case control study nested retrospective cohort where adverse outcomes were compared across several exposures using conditional multivariable logistic regression, adjusting for range demographic health characteristics. Eligible participants identified from the maternity services dataset (MSDS) records linked to hospital admission, testing databases. Matching criteria differed outcome but included participant’s age estimated week conception. Results 514,013 pregnant individuals aged between 18 50 years during period (births 16th April 2021-31st March 2022). Receiving at least one dose conferred lower odds giving birth baby who was low birthweight (aOR=0.86, 95% CI: 0.79 – 0.93), preterm (aOR=0.89, 0.85 - 0.92) or had an Apgar score less than 7 five mins 0.80 0.98). There stillbirth (aOR=0.90, 0.76 1.07), death (aOR=1.27, 0.91 1.77) perinatal (aOR=0.98, 0.83 1.16), venous thromboembolism (aOR=0.82, 0.43 1.56). The admission intensive care unit vaccinated women (aOR=0.85, 0.95). Conclusion vaccines safe use they confer protection against SARS-CoV-2 infection which can lead both mother infant. Our findings generated important information communicate professionals support programmes. What already known topic shows that first trimester late Most geographically limited, allowing inclusion representative country’s inhabitants. adds This population-based England investigating We used English data enabling huge numbers country. As such, able relevant research questions such administration before pregnancy, number doses How might affect research, practice policy further existing demonstrating all any point time gives confidence programme. demonstrated receiving multiple not associated additionally it there increased risk type.

Язык: Английский

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COVID‐19 Vaccine Safety in Pregnancy, A Nested Case–Control Study in Births From April 2021 to March 2022, England

BJOG An International Journal of Obstetrics & Gynaecology, Год журнала: 2024, Номер 131(13), С. 1882 - 1893

Опубликована: Сен. 16, 2024

ABSTRACT Objective Assessment of COVID‐19 vaccine safety in pregnancy using population‐based data. Design Matched case–control study nested a retrospective cohort. Setting April 2021–March 2022, England. Population or Sample All pregnant individuals aged between 18 and 50 years with valid health records. Methods Individuals identified from the national Maternity Services Data Set (MSDS) had their records linked to hospital admission, testing databases. Matching included participant's age estimated week conception. We compared outcomes across multiple exposures conditional multivariable logistic regression, adjusting for demographic characteristics. Main Outcome Measures Adverse pregnancy, maternal neonatal outcomes. Results 514 013 were included. found lower odds giving birth baby who was low birthweight (aOR = 0.86, 95% CI: 0.79–0.93), preterm 0.89, 0.85–0.92) an Apgar score < 7 at 5 min 0.80–0.98) received least one dose during pregnancy. The admission intensive care unit those vaccinated 0.85, 0.76–0.95). There no association vaccination stillbirth, death, perinatal death venous thromboembolism Conclusions vaccines are safe use Our findings generated important information communicate professionals support programmes.

Язык: Английский

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Maternal and Newborn Outcomes of SARS-CoV-2/COVID-19 and Pregnancy: Parallels and Contrasts with Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome

Medical Research Archives, Год журнала: 2024, Номер 12(4)

Опубликована: Янв. 1, 2024

Our review aims to compare and contrast Human Immunodeficiency Virus/Acquired Syndrome SARS-CoV-2/COVID-19's impact on maternal neonatal outcomes. We have made significant progress in prevention treatment over the last few decades. Drawing empirical evidence with past public health crises can offer valuable insights into dealing current future pandemics. Therefore, it is imperative conduct a comparative analysis of resemblances disparities existing between SARS-CoV-2/COVID-19.This research endeavor represents pioneering all-encompassing examination, aiming discern comprehend parallels contrasts respective impacts SARS-CoV-2 Virus pregnancy.

Язык: Английский

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