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Authors = Magdalena Tary-Lehmann

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15 pages, 1404 KiB  
Article
Safety and Immunogenicity of M2-Deficient, Single Replication, Live Influenza Vaccine (M2SR) in Adults
by Joseph Eiden, Gilad Gordon, Carlos Fierro, Renee Herber, Roger Aitchison, Robert Belshe, Harry Greenberg, Daniel Hoft, Yasuko Hatta, Michael J. Moser, Magdalena Tary-Lehmann, Yoshihiro Kawaoka, Gabriele Neumann, Paul Radspinner and Pamuk Bilsel
Vaccines 2021, 9(12), 1388; https://doi.org/10.3390/vaccines9121388 - 24 Nov 2021
Cited by 11 | Viewed by 3270
Abstract
M2SR (M2-deficient single replication) is an investigational live intranasal vaccine that protects against multiple influenza A subtypes in influenza-naïve and previously infected ferrets. We conducted a phase 1, first-in-human, randomized, dose-escalation, placebo-controlled study of M2SR safety and immunogenicity. Adult subjects received a single [...] Read more.
M2SR (M2-deficient single replication) is an investigational live intranasal vaccine that protects against multiple influenza A subtypes in influenza-naïve and previously infected ferrets. We conducted a phase 1, first-in-human, randomized, dose-escalation, placebo-controlled study of M2SR safety and immunogenicity. Adult subjects received a single intranasal administration with either placebo or one of three M2SR dose levels (106, 107 or 108 tissue culture infectious dose (TCID50)) expressing hemagglutinin and neuraminidase from A/Brisbane/10/2007 (H3N2) (24 subjects per group). Subjects were evaluated for virus replication, local and systemic reactions, adverse events (AE), and immune responses post-vaccination. Infectious virus was not detected in nasal swabs from vaccinated subjects. At least one AE (most commonly mild nasal rhinorrhea/congestion) was reported among 29%, 58%, and 83% of M2SR subjects administered a low, medium or high dose, respectively, and among 46% of placebo subjects. No subject had fever or a severe reaction to the vaccine. Influenza-specific serum and mucosal antibody responses and B- and T-cell responses were significantly more frequent among vaccinated subjects vs. placebo recipients. The M2SR vaccine was safe and well tolerated and generated dose-dependent durable serum antibody responses against diverse H3N2 influenza strains. M2SR demonstrated a multi-faceted immune response in seronegative and seropositive subjects. Full article
(This article belongs to the Special Issue Technologies for Influenza Vaccines that Provide Increased Speed, Efficacy and Ease of Administration)
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14 pages, 365 KiB  
Article
Dissecting the T Cell Response: Proliferation Assays vs. Cytokine Signatures by ELISPOT
by Donald D. Anthony, Kimberly A. Milkovich, Wenji Zhang, Benigno Rodriguez, Nicole L. Yonkers, Magdalena Tary-Lehmann and Paul V. Lehmann
Cells 2012, 1(2), 127-140; https://doi.org/10.3390/cells1020127 - 10 May 2012
Cited by 17 | Viewed by 9926
Abstract
Chronic allograft rejection is in part mediated by host T cells that recognize allogeneic antigens on transplanted tissue. One factor that determines the outcome of a T cell response is clonal size, while another is the effector quality. Studies of alloimmune predictors of [...] Read more.
Chronic allograft rejection is in part mediated by host T cells that recognize allogeneic antigens on transplanted tissue. One factor that determines the outcome of a T cell response is clonal size, while another is the effector quality. Studies of alloimmune predictors of transplant graft survival have most commonly focused on only one measure of the alloimmune response. Because differing qualities and frequencies of the allospecific T cell response may provide distinctly different information we analyzed the relationship between frequency of soluble antigen and allo-antigen specific memory IFN-g secreting CD4 and CD8 T cells, their ability to secrete IL-2, and their proliferative capacity, while accounting for cognate and bystander proliferation. The results show proliferative responses primarily reflect on IL-2 production by antigen-specific T cells, and that proliferating cells in such assays entail a considerable fraction of bystander cells. On the other hand, proliferation (and IL-2 production) did not reflect on the frequency of IFN-γ producing memory cells, a finding particularly accentuated in the CD8 T cell compartment. These data provide rationale for considering both frequency and effector function of pre-transplant T cell reactivity when analyzing immune predictors of graft rejection. Full article
(This article belongs to the Special Issue ELISPOT Research)
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