97 research outputs found

    Data in Support of Novavax XBB.1.5 Vaccine

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    09-COVID-Dubovsky-508.pd

    NVX-CoV2373 (Novavax COVID-19 vaccine) in adults ( 65 18 years of age)

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    04-COVID-Dubovsky-508.pd

    Data in Support of Novavax XBB.1.5 Vaccine

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    09-COVID-Dubovsky-508.pd

    Malaria vaccines

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    Quantitative detection of Plasmodium falciparum DNA in saliva, blood, and urine.

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    BACKGROUND: Current methods for detecting malaria parasites are invasive and associated with poor compliance when repeated sampling is required. New methods to detect and quantify parasites in a less-invasive manner would greatly enhance the potential for longitudinal surveillance in clinical trials. METHODS: Saliva, urine, and blood samples from 386 Gambian outpatients with suspected malaria infections were analyzed by nested polymerase chain reaction (nPCR) to detect infection and to evaluate diagnostic accuracy in comparison to expert microscopy. The amount of parasite DNA in malaria-positive samples was estimated using real-time quantitative PCR (qPCR). RESULTS: Blood parasite density as estimated by qPCR correlated well with parasite counts established by microscopy (p = 0.94; P or = 1000 parasites/microL. nPCR of urine had a sensitivity of 32% and a specificity of 98%. CONCLUSION: Saliva sampling is a promising less-invasive approach for detecting malaria infection

    History of Medicine - Correspondence with a pioneer, Jürgen Lehmann (1898 - 1989), producer of tl"le first effective antituberculosis specific

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    Correspondence between the author and Lehmann provided evidence that the latter evolved the first effective antituberculosis drug, para-aminosalicylic acid (PAS), contrary to accepted belief that this honour belonged to Nobel Prizewinner Selman A. Waksman for his production of streptomycin. While both drugs appeared in 1943, successful animal and clinical trials of PAS preceded those of streptomycin. PAS has been discarded in modern treatment regimens because of gastric side-effects, but was available at a critical time to demonstrate the principle of multiple therapy in prevention of bacterial resistance in tuberculosis therapy. It probably saved streptomycin, which causes bacterial resistance and clinical regression within 3 months when used alone, from being discarded as an unsuitable drug of temporary benefit and a public health hazard

    Biological Technical Publication FWS/BTP-R6017-2013

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    Blue-winged Teal (Anas discors; BWTE) are the second most abundant duck (family Anatidae) species in North America and are widely distributed (Rowher et al. 2002). Its breeding range stretches from the southern high-plains of New Mexico and Texas in the U.S., north to the boreal forest of Canada and Alaska, and from the Pacific to the Atlantic coast above approximately 40°N. from the southern high-plains of New Mexico and Texas in the U.S., north to the boreal forest of Canada and Alaska, and from the Pacific to the Atlantic coast above approximately 40°NU.S. Fish & Wildlife Service Distribution and Derivation of the Blue-winged Teal (Anas discors) Harvest, 1970 – 2003 Biological Technical Publication BTP-R6017-2013 Photo by Craig Bihrle i U.S. Fish & Wildlife Service Distribution and Derivation of the Blue-winged Teal (Anas discors) Harvest, 1970 – 2003 Biological Technical Publication BTP-R6017-2013 Michael L. Szymanski 1 James A. Dubovsky 2 1 North Dakota Game and Fish Department, Bismarck, ND 2 U. S. Fish and Wildlife Service, Division of Migratory Bird Management, Denver, CO Cover image: Blue-winged Teal Photo credit: Craig Bihrle, North Dakota Game and Fish Department ii Distribution and Derivation of the Blue-winged Teal Harvest Author Contact Information: Michael L. Szymanski North Dakota Game and Fish Department Migratory Game Bird Biologist 100 N. Bismarck Expressway Bismarck, ND 58501 Phone: (701) 328-6360 Email: [email protected] James A. Dubovsky U.S. Fish and Wildlife Service Central Flyway Representative Division of Migratory Bird Management 755 Parfet Street, Suite 235 Lakewood, CO 80215 Phone: (303) 275-2386 E-mail: [email protected] Recommended citation: Szymanski, M. L., and J. A. Dubovsky. 2013. Dis-tribution and derivation of the Blue-winged Teal (Anas discors) harvest, 1970–2003. U.S. Depart-ment of Interior, Fish and Wildlife Service, Biologi-cal Technical Publication FWS/BTP-R6017-2013, Washington, D.C. For additional copies or information, contact: Michael L. Szymanski North Dakota Game and Fish Department Migratory Game Bird Biologist 100 N. Bismarck Expressway Bismarck, ND 58501 Phone: (701) 328-6360 Email: [email protected] Series Senior Technical Editor: Stephanie L. Jones U.S. Fish and Wildlife Service Region 6 Nongame Migratory Bird Coordinator P.O. Box 25486-DFC Denver, CO 80225-0486 ISSN 2160-9498 Electronic ISSN 2160-9497 Biological Technical Publications online: http://library.fws.gov/BiologicalTechnicalPublications.html Table of Contents iii Table of Contents List of Figures .......................................................................................................................................................vii List of Tables .........................................................................................................................................................xi Acknowledgments .............................................................................................................................................. xii Executive Summary ........................................................................................................................................... xiii Introduction ........................................................................................................................................................... 1 Objectives .............................................................................................................................................................. 4 Methods ................................................................................................................................................................. 5 Datasets Used ..................................................................................................................................................... 5 Breeding population data............................................................................................................................... 5 Banding and band recovery data ................................................................................................................... 5 Harvest data ..................................................................................................................................................... 5 Development of Breeding Reference Areas .................................................................................................... 6 Development of Harvest Areas ......................................................................................................................... 6 Calculation of Distribution and Derivation of the Harvest ............................................................................ 6 Recovery weights................................................................................................................................................ 8 Pooling data among years ............................................................................................................................... 8 Band-reporting rates ....................................................................................................................................... 8 Estimation of the age and sex structure of the preseason population ........................................................9 Spatial Analysis of Recoveries ...........................................................................................................................10 Results and Discussion ........................................................................................................................................11 Breeding Reference Areas and Harvest Areas................................................................................................11 Recovery Weight Components............................................................................................................................11 Composite reporting rates...............................................................................................................................12 Harvest rates.......................................................................................................................................................13 Preseason population structure......................................................................................................................13 Band recovery rates.........................................................................................................................................14 Distribution and Relative Density of the Blue-winged Teal Harvest from Breeding Reference Areas to Major and Minor Harvest Areas, 1970 – 2003.............................................................................................14 All age/sex classes............................................................................................................................................14 Breeding reference areas west of 87°W..........................................................................................................14 Central Alberta BRA....................................................................................................................................14 Southern Alberta BRA.................................................................................................................................14 Western Saskatchewan BRA........................................................................................................................14 iv Distribution and Derivation of the Blue-winged Teal Harvest Eastern Saskatchewan/Southwest Manitoba BRA..................................................................................14 West-central Manitoba BRA........................................................................................................................20 Northern Great Plains BRA....................................................................................................................... 20 Eastern Dakotas BRA................................................................................................................................ 23 Upper Midwest BRA................................................................................................................................... 23 Breeding reference areas east of 87°W.......................................................................................................... 23 U.S. Great Lakes BRA................................................................................................................................ 23 Eastern Ontario/Southern Quebec BRA......................................................................................................... 23 Maritimes/Maine BRA............................................................................................................................... 23 Northeast States BRA..................................................................................................................................23 All breeding reference areas by age/sex class............................................................................................. 23 Adult males................................................................................................................................................... 23 Adult females................................................................................................................................................ 23 Immature males........................................................................................................................................... 23 Immature females....................................................................................................................................... 23 Derivation of the Blue-winged Teal Harvest from Breeding Reference Areas, 1970 – 2003.................... 30 All age/sex classes........................................................................................................................................... 30 Canada.............................................................................................................................................................. 30 Alberta........................................................................................................................................................... 30 Saskatchewan............................................................................................................................................... 30 Manitoba....................................................................................................................................................... 31 Ontario................................................................................................................................................................ 31 Quebec........................................................................................................................................................... 31 Maritimes Provinces.................................................................................................................................. 31 Pacific Flyway................................................................................................................................................... 31 Pacific Flyway – North............................................................................................................................... 39 Pacific Flyway – South............................................................................................................................... 39 Central Flyway................................................................................................................................................ 39 Central Flyway High Plains – North........................................................................................................ 39 Central Flyway Low Plains – North.......................................................................................................... 39 Central Flyway High Plains – South.............................................................................................................. 39 Central Flyway Low Plains – South......................................................................................................... 39 Mississippi Flyway.......................................................................................................................................... 39 Mississippi Flyway – Northwest............................................................................................................... 39 Mississippi Flyway – Northeast................................................................................................................ 39 Mississippi Flyway – West-central.................................................................................................................. 39 Mississippi Flyway – South....................................................................................................................... 39 Mississippi Flyway – Gulf Coast............................................................................................................... 39 Atlantic Flyway................................................................................................................................................ 39 Atlantic Flyway – North............................................................................................................................ 39 Atlantic Flyway – Central.......................................................................................................................... 39 Atlantic Flyway – South............................................................................................................................. 39 Latin America.................................................................................................................................................. 39 Mexico.............................................................................................................................................................39 Central America........................................................................................................................................... 39 South America.............................................................................................................................................. 39 Name of Section v Caribbean Countries.................................................................................................................................... 39 All harvest areas by age/sex class.................................................................................................................. 49 Adult males................................................................................................................................................... 49 Adult females................................................................................................................................................ 49 Immature males........................................................................................................................................... 49 Immature females........................................................................................................................................ 49 Changes in Distribution of the Blue-winged Teal Harvest between Time Periods.................................... 49 Changes in Derivation of the Blue-winged Teal Harvest between Time Periods...................................... 49 Grouping Breeding Reference Areas for Future Analyses........................................................................... 54 Bi-weekly Harvest of Blue-winged Teal.......................................................................................................... 55 Management Implications................................................................................................................................... 57 Literature Cited..................................................................................................................................................... 58 Appendix A. Numbers of Blue-winged Teal banded and direct recoveries by breeding reference area, time period, and age/sex class.......................................................................................................................... 60 Appendix B. Average annual harvest rates of Blue-winged Teal by breeding reference area, time period, and age/sex class.......................................................................................................................... 62 Appendix C. Blue-winged Teal recovery weights by breeding reference area, time period and age/sex class........................................................................................................................... 63 Appendix D. Distribution of the Blue-winged Teal harvest for all age/sex classes, 1970 – 1979.............. 65 Appendix E. Distribution of the Blue-winged Teal harvest for all age/sex classes, 1980 – 1986............... 66 Appendix F. Distribution of the Blue-winged Teal harvest for all age/sex classes, 1987 – 1993................ 67 Appendix G. Distribution of the Blue-winged Teal harvest for all age/sex classes, 1994 – 2003............... 68 Appendix H. Derivation of the Blue-winged Teal harvest for all age/sex classes, 1970 – 1979.................. 69 Appendix I. Derivation of the Blue-winged Teal harvest for all age/sex classes, 1980 – 1986................... 70 Appendix J. Derivation of the Blue-winged Teal harvest for all age/sex classes, 1987 – 1993.................. 71 Appendix K. Derivation of the Blue-winged Teal harvest for all age/sex classes, 1994 – 2003.................. 72 Appendix L. Relative harvest density of Blue-winged Teal derived from direct recoveries (n = 1,242) of all age/sex classes, 1 – 14 September, 1970 – 2003................................................................. 73 Appendix M. Relative harvest density of Blue-winged Teal derived from direct recoveries (n = 4,092) of all age/sex classes, 15 – 28 September, 1970 – 2003............................................................... 73 Appendix N. Relative harvest density of Blue-winged Teal derived from direct recoveries (n = 3,546) of all age/sex classes, 29 September – 12 October, 1970 – 2003................................................ 74 Appendix O. Relative harvest density of Blue-winged Teal derived from direct recoveries (n = 856) of all age/sex classes, 13 October – 26 October, 1970 – 2003........................................................ 74 Appendix P. Relative harvest density of Blue-winged Teal derived from direct recoveries (n = 520) of all age/sex classes, 27 October – 9 November, 1970 – 2003..................................................... 75 Table of Contents vi Distribution and Derivation of the Blue-winged Teal Harvest Appendix Q. Relative harvest density of Blue-winged Teal derived from direct recoveries (n = 825) of all age/sex classes, 10 November – 23 November, 1970 – 2003............................................... 75 Appendix R. Relative harvest density of Blue-winged Teal derived from direct recoveries (n = 552) of all age/sex classes, 24 November – 7 December, 1970 – 2003.................................................. 76 Appendix S. Relative harvest density of Blue-winged Teal derived from direct recoveries (n = 410) of all age/sex classes, 8 December – 21 December, 1970 – 2003.................................................. 76 Appendix T. Relative harvest density of Blue-winged Teal derived from direct recoveries (n = 521) of all age/sex classes, 22 December – 4 January, 1970 – 2003...................................................... 77 Appendix U. Relative harvest density of Blue-winged Teal derived from direct recoveries (n = 469) of all age/sex classes, 5 January – 18 January, 1970 – 2003.......................................................... 77 Appendix V. Relative harvest density of Blue-winged Teal derived from direct recoveries (n = 201) of all age/sex classes, 19 January – 1 February, 1970 – 2003....................................................... 78 Appendix W. Relative harvest density of Blue-winged Teal derived from direct recoveries (n = 167) of all age/sex classes, 2 February – 29 March, 1970 – 2003.......................................................... 78 List of Figures Figure 1. Breeding and wintering ranges for Blue-winged Teal (Anas discors; adapted from Bellrose 1980, Rowher et al. 2002) ...................................................................................................................................................... 1 Figure 2. Strata and transects for the Waterfowl Breeding Population and Habitat Survey (yellow = traditional survey area, green = eastern survey area; U.S. Fish and Wildlife Service 2009). .......................... 2 Figure 3. Blue-winged Teal harvests, 1970 – 2003 (Kruse et al. 2002, Gendron and Collins 2007, Kruse 2009). Latin American harvests (H) for each age/sex class are based on: HLatin American Area, age/sex class = [(HU.S., age/sex class + HCanada, age/sex class) / (1 – ρage/sex class)] - (HU.S., age/sexc lass + HCanada, age/sex class) .....................................................................................................................

    A Single Dose Monoclonal Antibody (mAb) Immunoprophylaxis Strategy to Prevent RSV Disease in All Infants: Results of the First in Infant Study with MEDI8897

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    Abstract Background RSV is the most common cause of lower respiratory tract infection (LRTI) among infants making prevention of RSV disease a public health priority. A significant unmet need exists for RSV prevention in healthy infants. Our goal is to develop a mAb with an extended half-life (t½) capable of protecting infants for an entire RSV season by using a single intramuscular (IM) dose. This study was conducted to evaluate the safety profile, pharmacokinetics (PK), RSV neutralizing antibody titers, and anti-drug antibody (ADA) responses for MEDI8897 in healthy preterm infants born between 32 and 35 weeks gestational age. Methods Infants were randomized 4:1 to receive a single IM injection of MEDI8897 10mg (n = 8), 25mg (n = 31), 50mg (n = 32) or placebo (n = 18) and followed for 360 days. Enrollment occurred during the 2,015 RSV seasons in the US, South Africa, and Chile. Blood was collected at multiple timepoints. Infants who met criteria for a medically-attended (MA) LRTI had nasal swabs obtained for RSV testing by RT-PCR. Results A total of 85/89 (95.5%) infants completed the study. Adverse events (AEs) were reported in 17/18 (94.4%) placebo and 66/71 (93.0%) MEDI8897 recipients. Five serious AEs (three LRTIs, two febrile seizures) were reported in three MEDI8897 recipients. No events were consistent with hypersensitivity reactions. The estimated MEDI8897 serum t½ ranged from 62.5 to 72.9 days. On day 151, 87% of the infants who received the 50mg dose of MEDI8897 had serum concentrations above the target EC90 level of 6.8 µg/ml, and 93.3% showed a ≥3-fold rise from baseline in serum anti-RSV neutralizing antibody titers. ADA was detected in 28.2% of MEDI8897 recipients, but when present was not associated with any safety findings. ADA was detected at day 361 only in 26.5% of subjects. MA-LRTI was reported in 5 (7%) MEDI8897 recipients through 150 days after dosing. The one subject with an MA-LRTI caused by RSV had received a 10mg dose of MEDI8897. Conclusion In healthy preterm infants, the safety profile of MEDI8897 was favorable. The extended t½ of MEDI8897 with the corresponding increase in RSV neutralizing antibody levels was confirmed and supports protection from RSV disease during a typical 5-month season with a single 50mg IM dose. This study was sponsored by MedImmune. Disclosures J. B. Domachowske, Medimmune: Investigator, Research grant; Regeneron: Investigator, Research grant; Pfizer: Investigator, Research grant; Glaxo Smith Kline: Investigator, Research grant; Novavax: Investigator, Research grant; Janssen: Investigator, Research grant; A. Khan, MedImmune: Employee and Shareholder, Salary and stock; M. T. Esser, MedImmune: Employee and Shareholder, Salary and stock; K. M. Jensen, MedImmune: Employee and Shareholder, Salary and stock; T. Takas, MedImmune: Employee and Shareholder, Salary and stock; T. Villafana, MedImmune: Employee and Shareholder, Salary and stock; F. Dubovsky, MedImmune: Employee and Shareholder, Salary and stock; M. P. Griffin, MedImmune: Employee and Shareholder, Salary and stock </jats:sec
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