PubMed:18077611 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PubMed/sourceid/18077611","sourcedb":"PubMed","sourceid":"18077611","source_url":"https://www.ncbi.nlm.nih.gov/pubmed/18077611","text":"A double-blind, randomized, controlled, multicenter safety and immunogenicity study of a refrigerator-stable formulation of Zostavax.\nThe vaccine Zostavax has been shown to prevent herpes zoster (HZ) and postherpetic neuralgia and is recommended for individuals \u003e or =60 years of age. This study compared the safety and the immunogenicity of a refrigerator-stable formulation (Zostavax refrigerated) with those of the current formulation (Zostavax frozen) in subjects \u003e or =50 years of age. Subjects with a negative history for HZ were randomized 1:1 to receive one dose of either formulation. Enrollment was stratified 1:2 by age (50 to 59 years and \u003e or =60 years). Safety was evaluated for 28 days postvaccination. Varicella-zoster virus (VZV) antibody responses were measured by a glycoprotein enzyme-linked immunosorbent assay (gpELISA). The primary endpoints were the VZV antibody geometric mean titer (GMT; day 28), the VZV antibody geometric mean rise (GMR; days 1 to 28), and the incidence of vaccine-related serious adverse experiences (AEs) over 28 days. The refrigerated (n = 182) and frozen (n = 185) formulations induced similar GMTs (727.4 and 834.4 gpELISA units/ml, respectively); the estimated GMT ratio (refrigerated formulation/frozen formulation) was 0.87 (95% confidence interval, 0.71 to 1.07). The GMRs were 2.6- and 2.9-fold, respectively. No vaccine-related serious AEs were reported in either group, and the safety profiles of the formulations were generally similar. The frequencies of injection-site AEs during follow-up were 35.6% and 46.4% in the refrigerated and the frozen formulation groups, respectively, and were generally mild. The frequencies of systemic AEs were similar in the two groups, and those of vaccine-related AEs were approximately 6% in both groups. The refrigerator-stable formulation of Zostavax has an acceptable safety profile and is as immunogenic as the frozen formulation; thus, the vaccine may be used in clinical settings where freezer availability is limited.","tracks":[{"project":"PMID_GLOBAL","denotations":[{"id":"T1","span":{"begin":181,"end":194},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T2","span":{"begin":196,"end":198},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T3","span":{"begin":204,"end":226},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T5","span":{"begin":528,"end":530},"obj":"DiseaseOrPhenotypicFeature"},{"id":"T6","span":{"begin":718,"end":727},"obj":"DiseaseOrPhenotypicFeature"}],"attributes":[{"id":"A1","pred":"mondo_id","subj":"T1","obj":"0005609"},{"id":"A2","pred":"mondo_id","subj":"T2","obj":"0005609"},{"id":"A3","pred":"mondo_id","subj":"T3","obj":"0005609"},{"id":"A4","pred":"mondo_id","subj":"T3","obj":"0041052"},{"id":"A5","pred":"mondo_id","subj":"T5","obj":"0005609"},{"id":"A6","pred":"mondo_id","subj":"T6","obj":"0005700"},{"subj":"T1","pred":"source","obj":"PMID_GLOBAL"},{"subj":"T2","pred":"source","obj":"PMID_GLOBAL"},{"subj":"T3","pred":"source","obj":"PMID_GLOBAL"},{"subj":"T5","pred":"source","obj":"PMID_GLOBAL"},{"subj":"T6","pred":"source","obj":"PMID_GLOBAL"}]}],"config":{"attribute types":[{"pred":"source","value type":"selection","values":[{"id":"PMID_GLOBAL","color":"#939fec","default":true}]}]}}