Affiliation: Food and Drug Administration
- Distinct cellular immune responses following primary and secondary influenza virus challenge in cotton ratsMaryna C Eichelberger
Virion Systems Inc, 9610 Medical Center Drive, Rockville, MD 20850, USA
Cell Immunol 243:67-74. 2006..These studies are the first to show evidence of a memory T cell response to influenza infection in cotton rats and show quantitative and qualitative differences between the recall response to homosubtypic and heterosubtypic viruses...
- The cotton rat as a model to study influenza pathogenesis and immunityMaryna C Eichelberger
Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland 20892, USA
Viral Immunol 20:243-9. 2007..This review describes innate and adaptive responses to influenza in infected cotton rats, and points out immune mechanisms that contribute to protection against disease...
- A miniaturized assay for influenza neuraminidase-inhibiting antibodies utilizing reverse genetics-derived antigensMatthew R Sandbulte
Division of Viral Products, Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, MD, USA
Influenza Other Respir Viruses 3:233-40. 2009..In addition, the assay is complicated by the need to use virus of a hemagglutinin (HA) subtype novel to the host to detect NA-specific antibodies only...
- Comparability of neuraminidase inhibition antibody titers measured by enzyme-linked lectin assay (ELLA) for the analysis of influenza vaccine immunogenicityMaryna C Eichelberger
Division of Viral Products, CBER, Food and Drug Administration, Silver Spring, MD, USA Electronic address
Vaccine 34:458-65. 2016..This study identified background signal and the amount of antigen in the assay as critical factors that influence titer, providing important information toward development of a consensus ELLA protocol. ..
- Influenza neuraminidase as a vaccine antigenMaryna C Eichelberger
Division of Viral Products, Office of Vaccine Research and Review, Center for Biologics Research and Regulation, US Food and Drug Administration, HFM445, Silver Spring, MD, 20892, USA
Curr Top Microbiol Immunol 386:275-99. 2015..Because NA induces heterologous immunity, it could be an important constituent of universal influenza vaccines that aim to protect against unexpected emerging viruses. ..
- Comparison of the effectiveness of antibody and cell-mediated immunity against inhaled and instilled influenza virus challengeKatie Rivers
Division of Viral Products, OVRR, CBER, FDA, 8800 Rockville Pike, Building 29A 1D24, Bethesda, MD 20892, USA
Virol J 10:198. 2013....
- Intramuscular immunization of mice with live influenza virus is more immunogenic and offers greater protection than immunization with inactivated virusKatie Harris
Division of Viral Products, Office of Vaccine Review and Research, Center for Biologics Evaluation and Research, Food and Drug Administration, USA
Virol J 8:251. 2011..A 2-dose regime of trivalent inactivated vaccine is required to generate protective levels of hemagglutination inhibiting (HAI) antibodies. A vaccine preparation with enhanced immunogenicity is therefore desirable...
- Antibody contributes to heterosubtypic protection against influenza A-induced tachypnea in cotton ratsTimothy M Straight
Department of Clinical Investigation, Brooke Army Medical Center, Fort Sam Houston, TX, USA
Virol J 5:44. 2008..Alternatively, H1N1-immune animals are protected from H3N2-induced tachypnea. The experiments described in this report were designed to elucidate the immune mechanism that prevents this very early sign of disease...
- Comparison of airway measurements during influenza-induced tachypnea in infant and adult cotton ratsElman L Trias
Children s National Medical Center, Washington, DC 20010, USA
BMC Pulm Med 9:28. 2009..We hypothesized that age-dependent differences in lung mechanics result in differences in ventilatory characteristics following influenza infection...
- Animal models to assess the toxicity, immunogenicity and effectiveness of candidate influenza vaccinesMaryna C Eichelberger
Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA
Expert Opin Drug Metab Toxicol 7:1117-27. 2011..To prevent adverse events that may be associated with these new vaccines, it is important to evaluate the toxicity of new formulations in animal models...
- Neuraminidase activity provides a practical read-out for a high throughput influenza antiviral screening assayMaryna C Eichelberger
Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD, USA
Virol J 5:109. 2008..To broaden the search for antivirals, cell-based replication assays can be performed, but these are often labor intensive and have limited throughput...
- Comparative glycomics analysis of influenza Hemagglutinin (H5N1) produced in vaccine relevant cell platformsYanming An
Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland 20892, USA
J Proteome Res 12:3707-20. 2013....
- Influenza-induced tachypnea is prevented in immune cotton rats, but cannot be treated with an anti-inflammatory steroid or a neuraminidase inhibitorMaryna C Eichelberger
Virion Systems Inc, Rockville MD 21205, USA
Virology 322:300-7. 2004..Therapeutic approaches need to be tailored to clear airway obstruction and restore an intact epithelium...
- The cotton rat provides a useful small-animal model for the study of influenza virus pathogenesisMartin G Ottolini
Department of Pediatrics, F Edward Hebert School of Medicine, The Uniformed Services University of the Health Sciences, Bethesda, MD 20814 4799, USA
J Gen Virol 86:2823-30. 2005..These results indicate that cotton rats will be useful for further studies of influenza pathogenesis and immunity...
- Label-free mass spectrometry-based quantification of hemagglutinin and neuraminidase in influenza virus preparations and vaccinesMelkamu Getie-Kebtie
Division of Cellular and Gene Therapies, OCTGT CBER FDA, Bethesda, MD, USA
Influenza Other Respir Viruses 7:521-30. 2013..An accurate rapid method to determine hemagglutinin (HA) concentration would facilitate reference antigen preparation and consequently expedite availability of seasonal as well as pandemic vaccines...
- Rapid detection and differentiation of swine-origin influenza A virus (H1N1/2009) from other seasonal influenza A virusesJiangqin Zhao
Laboratory of Molecular Virology, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA
Viruses 4:3012-9. 2012..This new method may be useful for simultaneous detection and subtyping of influenza A viruses and can be rapidly modified to detect other emerging influenza strains in public health settings...
- A practical influenza neutralization assay to simultaneously quantify hemagglutinin and neuraminidase-inhibiting antibody responsesArash Hassantoufighi
Division of Viral Products, Office of Vaccine Research and Review, Center for Biologics Evaluation and Research, FDA, Bethesda, MD 20892, USA
Vaccine 28:790-7. 2010..The AVINA assay is therefore a practical, comprehensive method to determine influenza vaccine immunogenicity and potential efficacy...
- Co-infection of the cotton rat (Sigmodon hispidus) with Staphylococcus aureus and influenza A virus results in synergistic diseaseLoRanee E Braun
Department of Pediatrics, F Edward Hebert School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA
Microb Pathog 43:208-16. 2007..aureus co-infection, with increased mortality and hypothermia as well as prolonged bacterial duration indicative of synergistic disease that may be the result of increased induction of both pro- and anti-inflammatory cytokines...
- An optimized enzyme-linked lectin assay to measure influenza A virus neuraminidase inhibition antibody titers in human seraLaura Couzens
Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Building 72, HFM445, Silver Spring, MD 20993, USA Electronic address
J Virol Methods 210:7-14. 2014..The ELLA described in this report provides a practical format for routine evaluation of human antibody responses to NA. ..
- FDA/NIH/WHO public workshop on immune correlates of protection against influenza A viruses in support of pandemic vaccine development, Bethesda, Maryland, US, December 10-11, 2007Maryna Eichelberger
US Food and Drug Administration, Center for Biologics Evaluation and Research Office of Vaccines Research and Review, Division of Viral Products, Bethesda, MD 20892, USA
Vaccine 26:4299-303. 2008....
- Confronting the next pandemic-Workshop on lessons learned from potency testing of pandemic (H1N1) 2009 influenza vaccines and considerations for future potency tests, Ottawa, Canada, July 27-29, 2010Stephanie Hardy
Health Canada, Biologics and Genetic Therapies Directorate, Ottawa, ON, Canada US Food and Drug Administration, Center for Biologics Evaluation and Research, Bethesda, MD, USA World Health Organization, Geneva, Switzerland
Influenza Other Respi Viruses 5:438-42. 2011..Influenza and Other Respiratory Viruses 5(6), 438-442...
- Rapid selection of oseltamivir- and peramivir-resistant pandemic H1N1 virus during therapy in 2 immunocompromised hostsMatthew J Memoli
Viral Pathogenesis and Evolution Section, Laboratory of Infectious Diseases, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20892 3203, USA
Clin Infect Dis 50:1252-5. 2010..We describe rapid selection for the H275Y resistance mutation during therapy in 2 immunocompromised individuals at 9 and 14 days of therapy, as well as the first described case of clinically significant resistance to peramivir...
- Rapid selection of a transmissible multidrug-resistant influenza A/H3N2 virus in an immunocompromised hostMatthew J Memoli
Respiratory Virus Pathogenesis and Evolution Section, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, MSC 3203 33 North Dr, Bethesda, MD 20892 3203, USA
J Infect Dis 201:1397-403. 2010..Antigenic drift and genetic variations during prolonged influenza infection have been demonstrated. In this report we describe a multidrug-resistant H3N2 influenza virus isolated from an immunocompromised patient after 5 days of therapy...
- Antigen-dependent proliferation and cytokine induction in respiratory syncytial virus-infected cotton rats reflect the presence of effector-memory T cellsBettina W M Richter
Virion Systems, Inc, Rockville, MD 20850 3347, USA
Virology 337:102-10. 2005..This supports the idea that the presence of effector-memory rather than central-memory T cells contributes to the ineffectiveness of the immune response to RSV...
- Evidence of a cross-protective immune response to influenza A in the cotton rat modelTimothy M Straight
Department of Clinical Investigation, Brooke Army Medical Center, 3400 Rawley E Chambers Avenue, Fort Sam Houston, TX 78234, USA
Vaccine 24:6264-71. 2006..Identification of the mechanisms that contribute to cross-protection in cotton rats may lead to the development of influenza vaccine strategies that are broadly protective...
- Clinical evaluation of a single oral dose of human-bovine (UK) reassortant rotavirus vaccines Wa x UK (P1A,G6) and Wa x (DS-1 x UK) (P1A,G2)Maryna C Eichelberger
Center for Immunization Research, Department of International Health, Johns Hopkins School of Public Health, Baltimore, Maryland, USA
J Med Virol 66:407-16. 2002..Each of these vaccines appeared to be well-tolerated and immunogenic in infants less than 6 months of age following a single oral dose, and therefore should be evaluated further as vaccine candidates...
- INITIATION OF VIRUS SPECIFIC CD8+ T CELL RESPONSESMaryna Eichelberger; Fiscal Year: 2002..This proposal is designed as an essential step towards the development of more effective influenza vaccine. ..
- Accelerated Viral Inhibition AssayMaryna Eichelberger; Fiscal Year: 2006..unreadable] [unreadable] [unreadable] [unreadable]..