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Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: A phase II, randomized, controlled study
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Infectious Diseases.
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2014 (English)In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 32, no 15, 1745-1753 p.Article in journal (Refereed) Published
Abstract [en]

Background: This study investigated the safety and immunogenicity of different formulations and schedules of a candidate subunit herpes zoster vaccine containing varicella-zoster virus glycoprotein E (gE) with or without the adjuvant system ASO1(B). Methods: In this phase II, single-blind, randomized, controlled study, adults aged >= 60 years (N = 714) received one dose of 100 mu g gE/AS01(B), two doses, two months apart, of 25, 50, or 100 mu g gE/AS01(B), or two doses of unadjuvanted 100 mu g gE/saline. Frequencies of CD4(+) T cells expressing >= 2 activation markers following induction with gE were measured by intracellular cytokine staining and serum anti-gE antibody concentrations by ELISA. Results: Frequencies of gE-specific CD4(+) T cells were >3-fold higher after two doses of all gE/AS01(B) formulations than after one dose of 100 mu g gE/AS01(B) or two doses of 100 mu g gE/saline. Frequencies were comparable after two doses of 25, 50, or 100 mu g gE/AS01g. Serum anti-gE antibody concentrations were comparable after two doses of 50 or 100 mu g gE/AS01(B) and higher than in the other groups. Immune responses persisted for at least 36 months. Reactogenicities of all gE/AS01(B) formulations were similar but greater than with gE/saline. Conclusions: The three formulations of gE/AS01(B) were immunogenic and well tolerated in adults aged >= 60 years. Two vaccinations with gE/AS01(B) induced higher immune responses than one and the dose of gE impacted humoral but not cellular immune responses (NCT00434577).

Place, publisher, year, edition, pages
2014. Vol. 32, no 15, 1745-1753 p.
Keyword [en]
Varicella-zoster virus, Herpes zoster, Vaccine, Adjuvant, gE
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:uu:diva-224365DOI: 10.1016/j.vaccine.2014.01.019ISI: 000333772600015OAI: oai:DiVA.org:uu-224365DiVA: diva2:716451
Available from: 2014-05-09 Created: 2014-05-09 Last updated: 2017-12-05Bibliographically approved

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Pauksens, Karlis

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