Human vaccines & immunotherapeutics
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Hum Vaccin Immunother · May 2017
Multicenter StudyImmunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults ≥ 50 years of age with a prior history of herpes zoster: A phase III, non-randomized, open-label clinical trial.
This phase III, non-randomized, open-label, multi-center study (NCT01827839) evaluated the immunogenicity and safety of an adjuvanted recombinant subunit herpes zoster (HZ) vaccine (HZ/su) in adults aged ≥ 50 y with prior physician-documented history of HZ. Participants (stratified by age: 50-59, 60-69 and ≥ 70 y) received 2 doses of HZ/su 2 months apart and were followed-up for another 12 months. Anti-glycoprotein E (gE) antibodies were measured by enzyme-linked immunosorbent assay before vaccination and 1 month after the second dose (Month 3). ⋯ Geometric mean anti-gE antibody concentrations at Month 3 were similar across age groups. 77.9% and 71.6% of participants reported local and general solicited AEs, respectively. The most frequent solicited AEs were pain at injection site, fatigue, headache, myalgia and shivering. The HZ/su vaccine was immunogenic in adults aged ≥ 50 y with a physician-documented history of HZ, and no safety concerns were identified.
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Vaccine information of varying quality is available through many different sources. We describe the creation, release and utilization of ReadyVax, a new mobile smartphone app providing access to trustworthy, evidence-based vaccine information for a target audience of healthcare providers, pharmacists, and patients (including parents of children). ⋯ ReadyVax has been downloaded by users in 102 different countries; most users (52%) are from the United States. We are continuing outreach efforts to increase app use, and planning for development of an Android-compatible version of ReadyVax, to increase the available market for the app.