Publications by authors named "Radha Railkar"

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Evaluation of a monoclonal antibody against respiratory syncytial virus, clesrovimab, in infants and children: Comprehensive rationale and study design for the late-stage clinical trials.
Anushua Sinha, Radha A Railkar, Luis Castagnini, Andrea Guerra, Andrea Likos

Contemp Clin Trials· October 2025

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Clesrovimab in Infants and Children at Increased Risk for Severe RSV Disease.
Heather J Zar, Louis J Bont, Paolo Manzoni, Flor M Muñoz, Octavio Ramilo, Radha A Railkar

N Engl J Med· October 2025

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Clesrovimab for Prevention of RSV Disease in Healthy Infants.
Heather J Zar, Eric A F Simões, Shabir A Madhi, Octavio Ramilo, Shelly D Senders, Radha A Railkar

N Engl J Med· October 2025

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Development of High-Titer Antidrug Antibodies in a Phase 1b/2a Infant Clesrovimab Trial Are Associated With RSV Exposure Beyond Day 150.
Nithya Thambi, Jia Yao Phuah, Ryan P Staupe, Lori M Tobias, Yu Cao, Radha A Railkar

J Infect Dis· March 2025

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A Phase 1b/2a Trial of a Half-life Extended Respiratory Syncytial Virus Neutralizing Antibody, Clesrovimab, in Healthy Preterm and Full-term Infants.
Shabir A Madhi, Eric A F Simões, Armando Acevedo, Jose M Novoa Pizarro, Julie S Shepard, Radha A Railkar

J Infect Dis· March 2025

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Quantification of clesrovimab, an investigational, half-life extended, anti-respiratory syncytial virus protein F human monoclonal antibody in the nasal epithelial lining fluid of healthy adults.
Jia Yao Phuah, Brian M Maas, Aimin Tang, Ying Zhang, Luzelena Caro, Radha A Railkar

Biomed Pharmacother· December 2023

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Evaluation of a stabilized RSV pre-fusion F mRNA vaccine: Preclinical studies and Phase 1 clinical testing in healthy adults.
Jesse Nussbaum, Xin Cao, Radha A Railkar, Jeffrey R Sachs, Daniel S Spellman

Vaccine· October 2023

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Replicate Testing of Clinical Endpoints Can Prevent No-Go Decisions for Beneficial Vaccines.
Daniel I S Rosenbloom, Julie Dudášová, Casey Davis, Radha A Railkar, Nitin Mehrotra

Vaccines (Basel)· September 2023

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Forward and reverse translational approaches to predict efficacy of neutralizing respiratory syncytial virus (RSV) antibody prophylaxis.
Brian M Maas, Jos Lommerse, Nele Plock, Radha A Railkar, S Y Amy Cheung

EBioMedicine· November 2021

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A phase 1, randomized, placebo-controlled study to evaluate the safety and immunogenicity of an mRNA-based RSV prefusion F protein vaccine in healthy younger and older adults.
Antonios O Aliprantis, Christine A Shaw, Paul Griffin, Nicholas Farinola, Radha A Railkar

Hum Vaccin Immunother· May 2021

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A Phase 1 Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of a Respiratory Syncytial Virus Neutralizing Monoclonal Antibody MK-1654 in Healthy Adults.
Antonios O Aliprantis, Dennis Wolford, Luzelena Caro, Brian M Maas, Hua Ma, Radha A Railkar

Clin Pharmacol Drug Dev· May 2021

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Effect of Endogenous Clostridioides difficile Toxin Antibodies on Recurrence of C. difficile Infection.
Ciarán P Kelly, Ian R Poxton, Judong Shen, Mark H Wilcox, Dale N Gerding, Radha Railkar

Clin Infect Dis· June 2020

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Fine-Needle Aspiration for the Evaluation of Hepatic Pharmacokinetics of Vaniprevir: A Randomized Trial in Patients With Hepatitis C Virus Infection.
Wei Gao, Andrea L Webber, Jill Maxwell, Melanie Anderson, Luzelena Caro, Radha Railkar

Clin Pharmacol Ther· June 2020

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"In-House" Data on the Outside-A Mobile Health Approach.
Qinlei Huang, Tami Crumley, Christina Walters, Liesbeth Cluckers, Ingeborg Heirman, Radha Railkar

Clin Pharmacol Ther· April 2020

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Bayesian methods for the design and analysis of noninferiority trials.
Margaret Gamalo-Siebers, Aijun Gao, Mani Lakshminarayanan, Guanghan Liu, Fanni Natanegara, Radha Railkar

J Biopharm Stat· November 2017

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Blood Aspergillus RNA is a promising alternative biomarker for invasive aspergillosis.
Yanan Zhao, Padmaja Paderu, Radha Railkar, Cameron Douglas, Robert Iannone

Med Mycol· November 2016

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Immune response and reactogenicity of intradermal administration versus subcutaneous administration of varicella-zoster virus vaccine: an exploratory, randomised, partly blinded trial.
Chan R Beals, Radha A Railkar, Andrea K Schaeffer, Yotam Levin, Efrat Kochba

Lancet Infect Dis· August 2016

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Correlation between Circulating Fungal Biomarkers and Clinical Outcome in Invasive Aspergillosis.
Dionysios Neofytos, Radha Railkar, Kathleen M Mullane, David N Fredricks, Bruno Granwehr

PLoS One· March 2016

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Pre-vaccination inflammation and B-cell signalling predict age-related hyporesponse to hepatitis B vaccination.
Slim Fourati, Razvan Cristescu, Andrey Loboda, Aarthi Talla, Ali Filali, Radha Railkar

Nat Commun· January 2016

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Early Clinical Detection of Pharmacologic Response in Insulin Action in a Nondiabetic Insulin-Resistant Population.
Sudha S Shankar, R Ravi Shankar, Radha A Railkar, Chan R Beals, Helmut O Steinberg

Curr Ther Res Clin Exp· December 2015

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High-dimensional analysis of the aging immune system: verification of age-associated differences in immune signaling responses in healthy donors.
Diane M Longo, Brent Louie, Jason Ptacek, Greg Friedland, Erik Evensen, Radha Railkar

J Transl Med· June 2014

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Reproducibility of hepatic fat fraction measurement by magnetic resonance imaging.
Arian Mashhood, Radha Railkar, Takeshi Yokoo, Yakir Levin, Lisa Clark

J Magn Reson Imaging· June 2013

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Repeatability of edited lactate and other metabolites in astrocytoma at 3T.
Mary A McLean, Amy Sun, Thomas E Bradstreet, Andrea K Schaeffer, Haiying Liu, Radha A Railkar

J Magn Reson Imaging· August 2012

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Evaluation of an experimental urodynamic platform to identify treatment effects: a randomized, placebo-controlled, crossover study in patients with overactive bladder.
Tara Frenkl, Radha Railkar, Neal Shore, James Bailen, Suzette Sutherland

Neurourol Urodyn· January 2012

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Test-retest repeatability of MR elastography for noninvasive liver fibrosis assessment in hepatitis C.
Norah J Shire, Meng Yin, Jun Chen, Radha A Railkar, Sabrina Fox-Bosetti

J Magn Reson Imaging· October 2011

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