Clinical Trial of Safety and Efficacy of IHN-A21 for the Prevention of Nosocomial Staphylococcal Bloodstream Infection in Premature Infants

DeJonge, Mitchell H.; Burchfield, David J.; Bloom, Barry T.; Dueñas, María; Walker, Whit; Polak, Mark J.; Jung, Elizabeth; Millard, Dietra D.; Schelonka, Robert L.; Eyal, Fabien G.; Morris, Amy; Kapik, Barry; Roberson, Destrey; Kesler, Karen; Patti, Joe; Hetherington, Seth

doi:10.1016/j.jpeds.2007.04.060

Cited by 140 publications

(84 citation statements)

References 34 publications

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“…In this study, no difference was observed between treatment groups in frequency of Staphylococcus aureus infections, 5% for INH-A21 vs 6% for placebo 23 . Pagibaximab, an anti-staphylococcal monoclonal antibody (anti-lipoteichoic acid) administered in 3 doses (7 days apart, 60 to 90 mg/kg/dose), was evaluated in a randomized, placebo controlled phase II study in infants with birth weight <1,300 g (n= 88).…”

Section: Ivig Prophylaxis and Adjuvant Therapycontrasting

confidence: 59%

Intravenous Immunoglobulin in Neonatal Sepsis

Jiang

Gautam

2013

J. Nepal Paedtr. Soc.

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Neonatal sepsis remains the major cause of mortality and morbidity including neurodevelopmental impairment and prolonged hospital stay in newborn infants. Despite of advances in technology and optimal antibiotic treatment, incidence of neonatal sepsis and its complications remains unacceptably high especially in developing countries. Premature neonates in particular are at higher risk due to developmentally immature host defense mechanisms. Though not approved by Food and Drug Administration (FDA) U.S.A, off label use of intravenous immunoglobulin continues in many countries. Recent evidences showed no significant decrease in the mortality rate or other outcomes when intravenous immunoglobulin is administered in addition to standard therapies. Hence, use of intravenous immunoglobulin in suspected or proven neonatal sepsis is not recommended. The expense of prophylactic use of intravenous immunoglobulin administration for both term and preterm newborn population, given the minimal benefit is not justified. Future studies are required which should focus on other prophylactic or adjuvant treatment modalities in addition to the standard therapy in neonatal sepsis.

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Section: Ivig Prophylaxis and Adjuvant Therapycontrasting

confidence: 59%

Intravenous Immunoglobulin in Neonatal Sepsis

Jiang

Gautam

2013

J. Nepal Paedtr. Soc.

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“…[100][101][102] There is very little literature published on reducing the risk of infection in preterm neonates and its effect on the incidence of ROP. Although there are single studies of interventions to prevent infection that also report ROP outcomes, [103][104][105] only those studying fluconazole prophylaxis had sufficient numbers for quantitative analysis. Despite a reduced risk of invasive fungal infection, fluconazole prophylaxis has no significant effect on the risk of developing severe ROP.…”

Section: Tablementioning

confidence: 99%

Interventions To Prevent Retinopathy of Prematurity: A Meta-analysis

Fang¹,

Sorita²,

Carey³

et al. 2016

Pediatrics

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CONTEXT: The effectiveness of many interventions aimed at reducing the risk of retinopathy has not been well established. OBJECTIVE:To estimate the effectiveness of nutritional interventions, oxygen saturation targeting, blood transfusion management, and infection prevention on the incidence of retinopathy of prematurity (ROP). DATA SOURCES:A comprehensive search of several databases was conducted, including Medline, Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus through March 2014. STUDY SELECTION:We included studies that evaluated nutritional interventions, management of supplemental oxygen, blood transfusions, or infection reduction and reported the incidence of ROP and mortality in neonates born at <32 weeks. DATA EXTRACTION:We extracted patient characteristics, interventions, and risk of bias indicators. Outcomes of interest were any stage ROP, severe ROP or ROP requiring treatment, and mortality. RESULTS:We identified 67 studies enrolling 21 819 infants. Lower oxygen saturation targets reduced the risk of developing any stage ROP (relative risk [RR] 0.86, 95% confidence interval [CI], 0.77-0.97) and severe ROP or ROP requiring intervention (RR 0.58, 95% CI, 0.45-0.74) but increased mortality (RR 1.15, 95% CI, 1.04-1.29). Aggressive parenteral nutrition reduced the risk of any stage ROP but not severe ROP. Supplementation of vitamin A, E, or inositol and breast milk feeding were beneficial but only in observational studies. Use of transfusion guidelines, erythropoietin, and antifungal agents were not beneficial. LIMITATIONS:Results of observational studies were not replicated in randomized trials. Interventions were heterogeneous across studies. CONCLUSIONS:At the present time, there are no safe interventions supported with high quality evidence to prevent severe ROP.

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“…To date, most of the clinical trials for vaccines or passive immunization against S. aureus, such as clinical trials of the Inhibitex vaccine, ClfA, SdrG (Veronate) (22,23), types 5 and 8 CPS conjugated to pseudomonal exoprotein A (17), and polyclonal antibodies to types 5 and 8 CPS (Altastaph) (24,25), have ended in failure. A recent review analyzed the reasons why many clinical trials of S. aureus vaccines have failed (26).…”

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confidence: 99%

Recombinant ESAT-6-Like Proteins Provoke Protective Immune Responses against Invasive Staphylococcus aureus Disease in a Murine Model

Zhang

Hua

et al. 2015

Infect Immun

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bStaphylococcus aureus is a common pathogen found in the community and in hospitals. Most notably, methicillin-resistant S. aureus is resistant to many antibiotics, which is a growing public health concern. The emergence of drug-resistant strains has prompted the search for alternative treatments, such as immunotherapeutic approaches. To date, most clinical trials of vaccines or of passive immunization against S. aureus have ended in failure. In this study, we investigated two ESAT-6-like proteins secreted by S. aureus, S. aureus EsxA (SaEsxA) and SaEsxB, as possible targets for a vaccine. Mice vaccinated with these purified proteins elicited high titers of anti-SaEsxA and anti-SaEsxB antibodies, but these antibodies could not prevent S. aureus infection. On the other hand, recombinant SaEsxA (rSaEsxA) and rSaEsxB could induce Th1-and Th17-biased immune responses in mice. Mice immunized with rSaEsxA and rSaEsxB had significantly improved survival rates when challenged with S. aureus compared with the controls. These findings indicate that SaEsxA and SaEsxB are two promising Th1 and Th17 candidate antigens which could be developed into multivalent and serotype-independent vaccines against S. aureus infection.

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Clinical Trial of Safety and Efficacy of IHN-A21 for the Prevention of Nosocomial Staphylococcal Bloodstream Infection in Premature Infants

Cited by 140 publications

References 34 publications

Intravenous Immunoglobulin in Neonatal Sepsis

Intravenous Immunoglobulin in Neonatal Sepsis

Interventions To Prevent Retinopathy of Prematurity: A Meta-analysis

Recombinant ESAT-6-Like Proteins Provoke Protective Immune Responses against Invasive Staphylococcus aureus Disease in a Murine Model

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