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Simberkoff M.S.,Veterans Affairs New York Harbor Healthcare System | Arbeit R.D.,Tufts Medical Center | Johnson G.R.,Veterans Affairs Connecticut Healthcare System | Oxman M.N.,Veterans Affairs Medical Center | And 12 more authors.
Annals of Internal Medicine | Year: 2010

Background: The herpes zoster vaccine is effective in preventing herpes zoster and postherpetic neuralgia in immunocompetent older adults. However, its safety has not been described in depth. Objective: To describe local adverse effects and short- and longterm safety profiles of herpes zoster vaccine in immunocompetent older adults. Design: Randomized, placebo-controlled trial with enrollment from November 1998 to September 2001 and follow-up through April 2004 (mean, 3.4 years). A Veterans Affairs Coordinating Center generated the permutated block randomization scheme, which was stratified by site and age. Participants and follow-up study personnel were blinded to treatment assignments. (ClinicalTrials.gov registration number: NCT00007501) Setting: 22 U.S. academic centers. Participants: 38 546 immunocompetent adults 60 years or older, including 6616 who participated in an adverse events substudy. Intervention: Single dose of herpes zoster vaccine or placebo. Measurements: Serious adverse events and rashes in all participants and inoculation-site events in substudy participants during the first 42 days after inoculation. Thereafter, vaccination-related serious adverse events and deaths were monitored in all participants, and hospitalizations were monitored in substudy participants. Results: After inoculation, 255 (1.4%) vaccine recipients and 254 (1.4%) placebo recipients reported serious adverse events. Local inoculation-site side effects were reported by 1604 (48%) vaccine recipients and 539 (16%) placebo recipients in the substudy. A total of 977 (56.6%) of the vaccine recipients reporting local side effects were aged 60 to 69 years, and 627 (39.2%) were older than 70 years. After inoculation, herpes zoster occurred in 7 vaccine recipients versus 24 placebo recipients. Long-term follow-up (mean, 3.39 years) showed that rates of hospitalization or death did not differ between vaccine and placebo recipients. Limitations: Participants in the substudy were not randomly selected. Confirmation of reported serious adverse events with medical record data was not always obtained. Conclusion: Herpes zoster vaccine is well tolerated in older, immunocompetent adults. Primary Funding Source: Cooperative Studies Program, Department of Veterans Affairs, Office of Research and Development; grants from Merck to the Veterans Affairs Cooperative Studies Program; and the James R. and Jesse V. Scott Fund for Shingles Research. Source

Weiner D.E.,Tufts University | McClean M.D.,Boston University | Kaufman J.S.,Veterans Affairs New York Harbor Healthcare System | Brooks D.R.,Boston University
Clinical Journal of the American Society of Nephrology | Year: 2013

Recent reports have described an apparent epidemic of CKD along the Pacific coast of Central America, such that CKD is a leading cause of death among working-age men in lower-altitude agricultural communities in this region. Given the limited availability of kidney replacement therapies in this region, CKD often is a terminal diagnosis, lending greater urgency to the identification of a modifiable cause. This article discusses the epidemiology of CKD in this region, reviews the clinical features of this CKD outbreak, discusses potential causes and the evidence supporting these hypotheses, and highlights the wider implications of this epidemic of CKD. Copyright © 2013 by the American Society of Nephro. Source

Lader J.M.,New York University | Lam G.,Veterans Affairs New York Harbor Healthcare System | Donnino R.,New York University | Katz E.S.,New York University | And 3 more authors.
Echocardiography | Year: 2014

A 48-year-old male with history of chronic arthritis and uveitis presented with 1 year of progressively reduced exercise capacity and nonexertional chest pain. Physical examination was consistent with severe aortic insufficiency. An electrocardiogram demonstrated sinus rhythm with first degree atrioventricular block. Transthoracic and transesophageal echocardiography demonstrated severe lone central aortic insufficiency of a trileaflet valve due to leaflet thickening, retraction of leaflet margins and mild aortic root dilation in the setting of left ventricular dilatation. In addition, computed tomographic angiography revealed a small focal aneurysm of the distal transverse arch. He was found to be positive for the immunogenetic marker HLA-B27. The patient subsequently underwent uncomplicated mechanical aortic valve replacement. The diagnosis of HLA-B27 associated cardiac disease should be entertained in any individual with lone aortic insufficiency, especially if accompanied by conduction disease. (Echocardiography 2014;31:E271-E274). © 2014, Wiley Periodicals, Inc. Source

Gorny M.K.,New York University | Sampson J.,New York University | Li H.,New York University | Jiang X.,New York University | And 10 more authors.
PLoS ONE | Year: 2011

Preferential usage of immunoglobulin (Ig) genes that encode antibodies (Abs) against various pathogens is rarely observed and the nature of their dominance is unclear in the context of stochastic recombination of Ig genes. The hypothesis that restricted usage of Ig genes predetermines the antibody specificity was tested in this study of 18 human anti-V3 monoclonal Abs (mAbs) generated from unrelated individuals infected with various subtypes of HIV-1, all of which preferentially used pairing of the VH5-51 and VL lambda genes. Crystallographic analysis of five VH5-51/VL lambda-encoded Fabs complexed with various V3 peptides revealed a common three dimensional (3D) shape of the antigen-binding sites primarily determined by the four complementarity determining regions (CDR) for the heavy (H) and light (L) chains: specifically, the H1, H2, L1 and L2 domains. The CDR H3 domain did not contribute to the shape of the binding pocket, as it had different lengths, sequences and conformations for each mAb. The same shape of the binding site was further confirmed by the identical backbone conformation exhibited by V3 peptides in complex with Fabs which fully adapted to the binding pocket and the same key contact residues, mainly germline-encoded in the heavy and light chains of five Fabs. Finally, the VH5-51 anti-V3 mAbs recognized an epitope with an identical 3D structure which is mimicked by a single mimotope recognized by the majority of VH5-51-derived mAbs but not by other V3 mAbs. These data suggest that the identification of preferentially used Ig genes by neutralizing mAbs may define conserved epitopes in the diverse virus envelopes. This will be useful information for designing vaccine immunogen inducing cross-neutralizing Abs. © 2011 Gorny et al. Source

Li L.,New York University | Wang X.-H.,Veterans Affairs New York Harbor Healthcare System | Banerjee S.,New York University | Volsky B.,New York University | And 4 more authors.
Human Antibodies | Year: 2012

The production of human monoclonal antibodies (mAbs) has been improved recently using the single B cell and PCR technology. A number of new anti-HIV-1 mAbs directed to various epitopes were produced by selecting single B cells from HIV positive individuals using the HIV-1 envelope (Env) proteins, and we tested whether the peptide can select B cells specific to a particular Env epitope. Using the fluorescently-labeled peptide tetramer representative of the V3 loop of HIV-1 Env gp120 for staining the B cells derived from one HIV-1 infected donor, four clonal human mAbs were produced with specificity to the V3 region. The clonality of the four V3 mAbs was based on the usage of the same immunoglobulin genes and almost identical sequence of CDRs. The amino acid changes were present only in the framework and, possibly, they could be related to the differences observed in the relative affinity binding of these four mAbs to V3 antigen. One representative V3 mAb displayed very potent neutralizing activity to one of two viruses tested. This study shows the feasibility of utilizing a peptide tetramer to select epitope-specific B cells and produce mAbs. © 2012 - IOS Press and the authors. All rights reserved. Source

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