Long-term immunogenicity and safety of an investigational herpes zoster subunit vaccine in older adults
Jazyk angličtina Země Nizozemsko Médium print-electronic
Typ dokumentu klinické zkoušky, fáze II, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
26432913
DOI
10.1016/j.vaccine.2015.09.073
PII: S0264-410X(15)01349-3
Knihovny.cz E-zdroje
- Klíčová slova
- Glycoprotein E, Immunogenicity, NCT01295320, Persistence, Subunit vaccine, Varicella-zoster virus,
- MeSH
- buněčná imunita * MeSH
- CD4-pozitivní T-lymfocyty imunologie MeSH
- fixní kombinace léků MeSH
- herpes zoster prevence a kontrola MeSH
- humorální imunita * MeSH
- lidé středního věku MeSH
- lidé MeSH
- lipid A aplikace a dávkování analogy a deriváty MeSH
- následné studie MeSH
- proteiny virového obalu imunologie MeSH
- protilátky virové krev MeSH
- saponiny aplikace a dávkování MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- subjednotkové vakcíny imunologie terapeutické užití MeSH
- vakcína proti pásovému oparu imunologie terapeutické užití MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- adjuvant system 01 MeSH Prohlížeč
- fixní kombinace léků MeSH
- lipid A MeSH
- proteiny virového obalu MeSH
- protilátky virové MeSH
- saponiny MeSH
- subjednotkové vakcíny MeSH
- vakcína proti pásovému oparu MeSH
BACKGROUND: An investigational subunit vaccine containing the varicella-zoster virus (VZV) glycoprotein E (gE) and the AS01B adjuvant system is being evaluated for the prevention of herpes zoster (HZ) in older adults. A phase II trial evaluating different formulations of this vaccine (containing 25μg, 50μg, or 100μg gE) was conducted in adults ≥60 years of age and showed that all formulations elicited robust cellular and humoral immune responses for up to 3 years after vaccination. In this follow-up study in subjects who received two doses of the 50μg gE/AS01B formulation (HZ/su), we assessed the persistence of the immune responses for up to 6 years after vaccination. METHODS: This phase II, open-label, multicenter, single-group trial conducted in the Czech Republic, Germany, Sweden, and the Netherlands followed 129 subjects who had received two doses (2 months apart) of HZ/su during the initial trial. Vaccine-induced immune responses (frequencies of gE-specific CD4(+) T cells expressing ≥2 activation markers and serum anti-gE antibody concentrations) were evaluated at 48, 60, and 72 months after the first HZ/su dose. RESULTS: Six years after vaccination with HZ/su, gE-specific cell-mediated immune responses and anti-gE antibody concentrations had decreased by 20-25% from month 36, but remained higher than the prevaccination values. At month 72, the gE-specific cell-mediated immune response was 3.8 times higher than the prevaccination value (477.3 vs. 119.4 activated gE-specific CD4(+) T cells per 10(6) cells), and the anti-gE antibody concentration was 7.3 times higher than the prevaccination value (8159.0 vs. 1121.3mIU/mL). No vaccine-related serious adverse events were reported between months 36 and 72. CONCLUSIONS: gE-specific cellular and humoral immune responses persisted for 6 years after two-dose vaccination with HZ/su in healthy older adults. No safety concerns were identified.
Central Laboratory and Vaccination Centre Stiftung Juliusspital Würzburg Germany
Faculty of Military Health Sciences University of Defence Hradec Kralove Czech Republic
GSK Vaccines King of Prussia PA USA
Municipal Public Health Service Rotterdam Rijnmond Rotterdam The Netherlands
Public Health Service Amsterdam Department of Infectious Diseases Amsterdam The Netherlands
Citace poskytuje Crossref.org
