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  1. AU="Le Cam Bouveret, Nancy"
  2. AU="Shetty, Sharanya B"
  3. AU="Paten, Benedict"
  4. AU="Molokhia, Ashraf"
  5. AU="Zirone, Eleonora"
  6. AU="Tong, Wenxia"
  7. AU="Chalira, Davie"
  8. AU="Hodane Yonis"
  9. AU="Boggiano, César"
  10. AU="Gainor, Justin F"
  11. AU="Scurr, David J"
  12. AU="Mahuran, Don J"
  13. AU="Dominguez, Dana A"
  14. AU=Mota Gustavo R
  15. AU="Pandey, Gayathri"
  16. AU=Kiesslich Ralf
  17. AU="Wiskar, Katie"
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  20. AU="Wildman, Ricky D."
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  22. AU="Loens, Christopher"
  23. AU="Friedman, Lawrence M."
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  26. AU="G. E-S. Batiha"
  27. AU=Johnson Guyla G
  28. AU="Patel, Parth H"
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  30. AU="Kirk, Tom"
  31. AU="Bezabih, Yihienew Mequanint"
  32. AU="Hirsinger, Estelle"
  33. AU="Robles-Musso Castillo, Emilio"
  34. AU="Vahdatihassani, Faezeh"
  35. AU="Maria Pala"
  36. AU=Singh Indra
  37. AU="Gallacher, Nicola"
  38. AU="Chen, Pei-Min"
  39. AU=Andre L
  40. AU="Aleksandra I. Pivovarova"
  41. AU="Cruz, Thainá Gabriele Camargo da"
  42. AU="Atkins, Peter"

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  1. Artikel: A phase 2 study of the bivalent VLP norovirus vaccine candidate in older adults; impact of MPL adjuvant or a second dose

    Treanor, John / Sherwood, Jim / Cramer, Jakob P / Le Cam Bouveret, Nancy / Lin, Stella / Baehner, Frank / Borkowski, Astrid

    Vaccine. 2020 Aug. 10, v. 38, no. 36

    2020  

    Abstract: Acute norovirus gastroenteritis causes significant morbidity and in uncommon cases fatality in older adults. We investigated the safety and immunogenicity of bivalent virus-like particle (VLP) vaccine candidate formulations with and without ... ...

    Körperschaft the NOR-204 investigators
    Abstract Acute norovirus gastroenteritis causes significant morbidity and in uncommon cases fatality in older adults. We investigated the safety and immunogenicity of bivalent virus-like particle (VLP) vaccine candidate formulations with and without monophosphoryl lipid A (adjuvant MPL) in this population.In this phase II, double-blind, controlled trial 294 healthy adults, ≥ 60 years of age, were randomized (1:1:1:1) to four groups to receive one or two intramuscular immunizations 28 days apart, with 26 18–49 year-old controls who received one MPL-free dose. One-dose groups received placebo on Day 1. Vaccine formulations contained 15 μg GI.1 and 50 μg GII.4c VLP antigens and 500 μg Al(OH)₃, with or without 15 μg MPL. We measured histo-blood group antigen blocking (HBGA) antibodies and ELISA Ig at Days 1, 8, 29, 57, 211 and 393, and avidity indices and cell-mediated immunity (CMI). Solicited local and systemic adverse events (AE) were assessed for 7 days and unsolicited AEs for 28 days after each injection.After one dose HBGA antibodies to both VLP antigens increased with similar kinetics and magnitude in all groups; geometric mean titres (GMTs) persisted above baseline through Day 393. GMTs were similar across age strata (18–49, 60–74, 75–84 and ≥ 85 years of age) and unaffected by a second vaccination or MPL. Total Ig showed similar responses. No clinically relevant differences or changes in avidity or CMI were observed between formulations. Both formulations were well tolerated with no vaccine-related SAEs, the most frequent AEs being mild injection site pain and fatigue.Adults over 60 years of age displayed no safety concerns and had similar immune responses to the norovirus VLP vaccine candidate as younger adults, unaffected by increasing age, a second dose or inclusion of MPL. This data supports the further development of the MPL-free vaccine candidate for older adults.
    Schlagwörter adjuvants ; antigens ; cell-mediated immunity ; death ; gastroenteritis ; immunogenicity ; injection site ; lipid A ; morbidity ; pain ; placebos ; vaccination ; virus-like particle vaccines
    Sprache Englisch
    Erscheinungsverlauf 2020-0810
    Umfang p. 5842-5850.
    Erscheinungsort Elsevier Ltd
    Dokumenttyp Artikel
    Anmerkung NAL-AP-2-clean
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2020.06.011
    Datenquelle NAL Katalog (AGRICOLA)

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  2. Artikel ; Online: A phase 2 study of the bivalent VLP norovirus vaccine candidate in older adults; impact of MPL adjuvant or a second dose.

    Treanor, John / Sherwood, Jim / Cramer, Jakob P / Le Cam Bouveret, Nancy / Lin, Stella / Baehner, Frank / Borkowski, Astrid

    Vaccine

    2020  Band 38, Heft 36, Seite(n) 5842–5850

    Abstract: Introduction: Acute norovirus gastroenteritis causes significant morbidity and in uncommon cases fatality in older adults. We investigated the safety and immunogenicity of bivalent virus-like particle (VLP) vaccine candidate formulations with and ... ...

    Abstract Introduction: Acute norovirus gastroenteritis causes significant morbidity and in uncommon cases fatality in older adults. We investigated the safety and immunogenicity of bivalent virus-like particle (VLP) vaccine candidate formulations with and without monophosphoryl lipid A (adjuvant MPL) in this population.
    Methods: In this phase II, double-blind, controlled trial 294 healthy adults, ≥ 60 years of age, were randomized (1:1:1:1) to four groups to receive one or two intramuscular immunizations 28 days apart, with 26 18-49 year-old controls who received one MPL-free dose. One-dose groups received placebo on Day 1. Vaccine formulations contained 15 μg GI.1 and 50 μg GII.4c VLP antigens and 500 μg Al(OH)
    Results: After one dose HBGA antibodies to both VLP antigens increased with similar kinetics and magnitude in all groups; geometric mean titres (GMTs) persisted above baseline through Day 393. GMTs were similar across age strata (18-49, 60-74, 75-84 and ≥ 85 years of age) and unaffected by a second vaccination or MPL. Total Ig showed similar responses. No clinically relevant differences or changes in avidity or CMI were observed between formulations. Both formulations were well tolerated with no vaccine-related SAEs, the most frequent AEs being mild injection site pain and fatigue.
    Conclusions: Adults over 60 years of age displayed no safety concerns and had similar immune responses to the norovirus VLP vaccine candidate as younger adults, unaffected by increasing age, a second dose or inclusion of MPL. This data supports the further development of the MPL-free vaccine candidate for older adults.
    Mesh-Begriff(e) Aged ; Aged, 80 and over ; Antibodies, Viral ; Double-Blind Method ; Gastroenteritis ; Humans ; Lipid A/analogs & derivatives ; Middle Aged ; Norovirus ; Receptors, Thrombopoietin ; Vaccines, Virus-Like Particle
    Chemische Substanzen Antibodies, Viral ; Lipid A ; Receptors, Thrombopoietin ; Vaccines, Virus-Like Particle ; MPL protein, human (143641-95-6) ; monophosphoryl lipid A (MWC0ET1L2P)
    Sprache Englisch
    Erscheinungsdatum 2020-06-17
    Erscheinungsland Netherlands
    Dokumenttyp Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2020.06.011
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  3. Artikel ; Online: Needle-free jet injection for administration of influenza vaccine: a randomised non-inferiority trial.

    McAllister, Linda / Anderson, Jonathan / Werth, Kristen / Cho, Iksung / Copeland, Karen / Le Cam Bouveret, Nancy / Plant, David / Mendelman, Paul M / Cobb, David K

    Lancet (London, England)

    2014  Band 384, Heft 9944, Seite(n) 674–681

    Abstract: Background: Administration of vaccines by needle-free technology such as jet injection might offer an alternative to needles and syringes that avoids the issue of needle phobia and the risk of needle-stick injury. We aimed to assess the immunogenicity ... ...

    Abstract Background: Administration of vaccines by needle-free technology such as jet injection might offer an alternative to needles and syringes that avoids the issue of needle phobia and the risk of needle-stick injury. We aimed to assess the immunogenicity and safety of trivalent influenza vaccine given by needle-free jet injector compared with needle and syringe.
    Methods: For this randomised, comparator-controlled trial, we randomly assigned (1:1) healthy adults (aged 18-64 years) who attended one of four employee health clinics in the University of Colorado health system, with stratification by site, to receive one dose of the trivalent inactivated influenza vaccine Afluria given either intramuscularly with a needle-free jet injector (Stratis; PharmaJet, Golden, CO, USA) or with needle and syringe. Randomisation was done with a computer-generated randomisation schedule with a block size of 100. Because of the nature of the study, masking of participants was not possible. Immunogenicity was assessed by measurement of the hemagglutination inhibition antibody titres in serum for the three viral strains included in the vaccine. We included six coprimary endpoints: three strain-specific geometric mean titre ratios and the absolute differences in three strain-specific seroconversion rates. The immune response of the jet injector group was regarded as non-inferior to that of the needle and syringe group if both the upper bound of each of the three 95% CIs for the strain-specific geometric mean titre ratios was 1.5 or less, and the upper bound of the three 95% CIs for the strain-specific seroconversion rate differences was less than 10 percentage points. We used t test for group comparison. This study is registered with ClinicalTrials.gov, number NCT01688921.
    Findings: During the 2012-13 influenza season of the northern hemisphere, we allocated 1250 participants to receive vaccination by needle-free jet injector (n=627) or needle and syringe (n=623). In the intention-to-treat immunogenicity population, all participants with two serum samples were included (575 in the jet injector group and 574 in the needle and syringe group). The immune response to Afluria when given by needle-free jet injector met the criteria for non-inferiority for all six coprimary endpoints. The jet injector group met the geometric mean titre criterion for non-inferiority for the A/H1N1, A/H3N2, and B strains (upper bound of the 95% CI for the geometric mean titre ratios were 1·10 for A/H1N1, 1·17 for A/H3N2, and 1·04 for B strains). The jet injector group met the seroconversion rate criterion for non-inferiority for the A/H1N1, A/H3N2, and B strains (upper bound of the 95% CI of the seroconversion rate differences were 6·0% for A/H1N1, 7·0% for A/H3N2, and 5·7% for B strains). We recorded serious adverse events in three participants, none of which were study related.
    Interpretation: The immune response to influenza vaccine given with the jet injector device was non-inferior to the immune response to influenza vaccine given with needle and syringe. The device had a clinically acceptable safety profile, but was associated with a higher frequency of local injection site reactions than was the use of needle and syringe. The Stratis needle-free jet injector device could be used as an alternative method of administration of Afluria trivalent influenza vaccine.
    Funding: Biomedical Advanced Research and Development Authority (BARDA), PATH, bioCSL, and PharmaJet.
    Mesh-Begriff(e) Adolescent ; Adult ; Aged, 80 and over ; Child ; Colorado ; Female ; Humans ; Influenza Vaccines/administration & dosage ; Influenza Vaccines/adverse effects ; Influenza Vaccines/immunology ; Influenza, Human/immunology ; Influenza, Human/psychology ; Influenza, Human/virology ; Injections, Intramuscular ; Injections, Jet ; Male ; Middle Aged ; Needles ; Outcome and Process Assessment (Health Care)
    Chemische Substanzen Influenza Vaccines
    Sprache Englisch
    Erscheinungsdatum 2014-08-23
    Erscheinungsland England
    Dokumenttyp Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(14)60524-9
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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