Current Clinical Microbiology Reports, Год журнала: 2025, Номер 12(1)
Опубликована: Апрель 10, 2025
Язык: Английский
JAMA Network Open, Год журнала: 2024, Номер 7(7), С. e2419268 - e2419268
Опубликована: Июль 8, 2024
Importance A nonadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF [Pfizer]) protein subunit vaccine was newly approved and recommended for pregnant individuals at 32 0/7 to 36 6/7 weeks’ gestation during the 2023 2024 RSV season; however, clinical data are lacking. Objective To evaluate association between prenatal vaccination status perinatal outcomes among patients who delivered season. Design, Setting, Participants This retrospective observational cohort study conducted 2 New York City hospitals within 1 health care system gave birth singleton gestations or later from September 22, 2023, January 31, 2024. Exposure Prenatal with RSVpreF captured system’s electronic records. Main Outcome Measures The primary outcome is preterm (PTB), defined as less than 37 gestation. Secondary included hypertensive disorders of pregnancy (HDP), stillbirth, small-for–gestational age weight, neonatal intensive unit (NICU) admission, distress NICU jaundice hyperbilirubinemia, hypoglycemia, sepsis. Logistic regression models were used estimate odds ratios (ORs), multivariable logistic time-dependent covariate Cox performed. Results Of 2973 (median [IQR] age, 34.9 [32.4-37.7] years), 1026 (34.5%) received vaccination. Fifteen inappropriately in nonvaccinated group. During period, 60 had evidence (5.9%) experienced PTB vs 131 those did not (6.7%). associated an increased risk after adjusting potential confounders (adjusted OR, 0.87; 95% CI, 0.62-1.20) addressing immortal time bias (hazard ratio [HR], 0.93; 0.64-1.34). There no significant differences based on models, but HDP model seen (HR, 1.43; 1.16-1.77). Conclusions Relevance In this later, outcomes. These support safety vaccination, further investigation into warranted.
Язык: Английский
Процитировано
24
The Lancet, Год журнала: 2024, Номер 404(10458), С. 1143 - 1156
Опубликована: Сен. 1, 2024
Язык: Английский
Процитировано
17
Obstetrics and Gynecology, Год журнала: 2025, Номер unknown
Опубликована: Янв. 2, 2025
OBJECTIVE: To describe preterm birth frequency and newborn infant outcomes overall among children in the MATISSE (Maternal Immunization Study for Safety Efficacy) trial of maternal vaccination with bivalent respiratory syncytial virus (RSV) prefusion F protein–based vaccine (RSVpreF) to protect infants against severe RSV-associated illness. METHODS: was a global, phase 3, randomized, double-blind trial. Pregnant individuals received single injections RSVpreF or placebo. Adverse events special interest, including (gestational age less than 37 weeks) low weight (2,500 g less), were collected through 6 months after delivery (pregnant participants) from 12 24 (pediatric participants). RESULTS: Overall, 7,386 pregnant participants (n=3,698) placebo (n=3,688); 7,305 newborns included analysis. Most both groups born full term (more 93%) normal (95% higher). Newborn outcomes, rates neonatal hospitalization, favorable comparable between groups. Preterm 5.7% arm 4.7% (relative risk [RR] 1.20, 95% CI, 0.98–1.46); most late preterm. Twenty-two deaths occurred during study (RSVpreF n=8, n=14). When stratified by income region, recipients 5.0% high-income countries. Rates non–high-income countries 7.0% 4.0% groups, respectively, 8.3% South Africa (RR 2.06, 1.21–3.51). CONCLUSION: In this vaccination, no clinically significant increase adverse birth, weight, observed people subgroup analysis countries, an elevated observed. More research is needed better ascertain factors, particularly aimed at minimizing disparities geographic regions. FUNDING SOURCE: This sponsored Pfizer. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04424316.
Язык: Английский
Процитировано
4
Therapeutic Advances in Vaccines and Immunotherapy, Год журнала: 2025, Номер 13
Опубликована: Янв. 1, 2025
Respiratory syncytial virus (RSV) causes a significant burden of acute respiratory illness across all ages, particularly for infants and older adults. Infants, especially those born prematurely or with underlying health conditions, face high risk severe RSV-related lower tract infections (LRTIs). Globally, RSV contributes to millions LRTI cases annually, disproportionate in low- middle-income countries (LMICs). The virion outer capsule contains glycoproteins G F which are essential viral entry into epithelial cells represent key targets therapeutics development. F-glycoprotein has several highly conserved antigenic sites that have proven useful the development monoclonal antibodies (mAbs) against RSV. Historically, prevention was limited mAb palivizumab, which, despite its efficacy, costly inaccessible many regions. Recent advancements include nirsevimab, long-acting shown substantial efficacy reducing medically attended disease infants, phase III clinical trials, early regional national real-world data. In addition, three new vaccines been approved: two protein subunit messenger RNA vaccine. licenced use adults, one also approved as maternal Promising candidates clesrovimab, an extended half-life levels nasal lining safety profiles late-stage trials. There wide range vaccine currently These developments signify major advancement strategies, offering improved protection high-risk populations. With ongoing rollout recently mAbs internationally, landscape care is rapidly changing. We must ensure these advances reach LMICs who need therapies most.
Язык: Английский
Процитировано
2
The Lancet, Год журнала: 2024, Номер 404(10458), С. 1157 - 1170
Опубликована: Сен. 1, 2024
Язык: Английский
Процитировано
12
New England Journal of Medicine, Год журнала: 2024, Номер 390(11), С. 1050 - 1051
Опубликована: Март 13, 2024
Respiratory syncytial virus (RSV) poses a substantial burden to the health of infants. An estimated 1.4 million RSV-associated hospitalizations and 45,700 RSV-attributable deaths occur worldwide each year in infants younger than 6 months age.1 In United States, RSV is leading cause hospitalization among infants, with 2 3% age hospitalized for infection annually.2 Recently, two agents protect young from severe disease have become available. July 2023, Food Drug Administration (FDA) approved nirsevimab, long-acting monoclonal antibody,3 use infants; 1 month .
Язык: Английский
Процитировано
10
Vaccines, Год журнала: 2024, Номер 12(6), С. 640 - 640
Опубликована: Июнь 8, 2024
A systematic review with a meta-analysis was performed to gather available evidence on the effectiveness of monoclonal antibody nirsevimab in prevention lower respiratory tract diseases (LRTDs) due syncytial virus (RSV) children and newborns (CRD42024540669). Studies reporting real-world experience randomized controlled trials (RCTs) were searched for three databases (PubMed, Embase, Scopus) until 1 May 2024. Our analysis included five RCTs, seven reports, one official report from health authorities. Due cross-reporting RCTs inclusion multiple series single study, 45,238 infants 19 series. The documented pooled immunization efficacy 88.40% (95% confidence interval CI) 84.70 91.21) occurrence hospital admission RSV, moderate heterogeneity (I2 24.3%, 95% CI 0.0 56.6). Immunization decreased overall length observation time (Spearman’s r = −0.546, p 0.016), risk breakthrough infections substantially greater studies times ≥150 days compared lasting <150 (risk ratio 2.170, 1.860 2.532). However, effect meta-regression conflicting (β 0.001, −0.001 0.002; 0.092). In conclusion, delivery quite effective preventing admissions LRTDs. further analyses whole RSV season are required before tailoring specific public interventions.
Язык: Английский
Процитировано
10
Human Vaccines & Immunotherapeutics, Год журнала: 2024, Номер 20(1)
Опубликована: Май 9, 2024
Respiratory Syncytial Virus poses a significant global public health threat, particularly affecting infants aged less than one year of age. Recently, two forms passive immunization against infant RSV have been developed and brought to market; nirsevimab long-acting monoclonal antibody (mAb) RSV-PreF, maternal vaccine. The acceptability uptake these products will play pivotal role in determining the success any national strategy aimed at safeguarding from RSV. It is crucial this time reflect on factors that influence parental decisions surrounding facilitate more informed discussions, enhance healthcare communication, contribute design effective prevention strategies resonate with concerns aspirations parents worldwide.
Язык: Английский
Процитировано
8
Vaccines, Год журнала: 2025, Номер 13(2), С. 97 - 97
Опубликована: Янв. 21, 2025
Respiratory syncytial virus (RSV) causes significant morbidity and mortality, especially in young children the elderly. RSV vaccine development puzzled vaccinologists for years. Safety concerns of initial formulations, lack an absolute correlate protection, need selecting appropriate attenuation antigen–adjuvant combinations contributed to delayed production. The recent stabilization RSV-F glycoprotein prefusion (preF) conformation that constitutes primary target RSV-neutralizing antibodies was key efficient design. Two protein subunit vaccines (GSK’s Arexvy Pfizer’s Abrysvo) one mRNA (Moderna’s mRESVIA) are now available. This article aims provide a comparative overview safety efficacy novel approved prevention RSV-lower respiratory tract disease (LRTD) adults 60 years age older, with updated recommendations calling expansion vaccination all at increased risk severe disease. Abrysvo is only indicated use pregnancy prevent RSV-LRTD infants from birth 6 months age. We assessment over maximum three seasons, summarizing currently available data. conclude despite decreasing time, which should be anticipated characterized by short-term immunity, clinically meaningful placebo. Guillain–Barré syndrome post or Arexvy, prompted FDA require inclusion such warnings prescribing information these two vaccines, prioritized investigated thoroughly. Furthermore, ongoing surveillance further evaluation, particularly among immunocompromised patients, frail elderly subjects, were under- not represented pivotal clinical trials, necessary. As success story combined pediatric combination conferring protection against several illnesses dose, could help improve acceptance coverage rates older adults.
Язык: Английский
Процитировано
1
BMJ Open, Год журнала: 2025, Номер 15(4), С. e087850 - e087850
Опубликована: Апрель 1, 2025
Objectives To describe the post-marketing safety profile of respiratory syncytial virus prefusion F (RSVpreF) vaccine among pregnant individuals. Design This study analysed adverse event (AE) reports submitted to U.S. Food and Drug Administration’s Vaccine Adverse Event Reporting System (VAERS) database following RSVpreF immunisation from 1 September 2023 23 February 2024. Setting VAERS, as a national spontaneous surveillance system, provides insights into in real-world setting. Participants Surveillance data included all AE VAERS individuals vaccination. Exposure Receipt USA. Primary secondary outcome measures Descriptive statistics were used assess with RSVpreF, including frequency, gestational age at vaccination, time onset, reported outcomes proportion serious reports. Data mining techniques employed identify disproportionate reporting RSVpreF-event pairs. Reports preterm births clinically reviewed. Results received 77 pertaining vaccination individuals, 42 (54.55%) classified serious. The most frequently non-pregnancy-specific AEs headache, injection site erythema pain. For pregnancy-specific AEs, birth was (12.8%), followed by terms such premature rupture membranes caesarean section (each 3.3%), cervical dilatation, haemorrhage during pregnancy uterine contractions 1.4%). Our disproportionality analysis indicated signals for various particularly birth, indicating that conjunction observed more than statistically expected. Most moderate late, occurring between 32 less 37 weeks gestation. median onset 3 days, two-thirds cases within week Conclusions vaccinated largely aligned prelicensure studies; however, this also highlights previously signal birth. Active studies focusing on maternal perinatal are needed further evaluate guide future clinical recommendations.
Язык: Английский
Процитировано
1