Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults >=50 years of age
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky, fáze II, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
23904292
DOI
10.1093/infdis/jit365
PII: jit365
Knihovny.cz E-zdroje
- Klíčová slova
- adjuvant, immunogenicity, recombinant subunit vaccine, safety, varicella-zoster virus,
- MeSH
- adjuvancia imunologická MeSH
- CD4-pozitivní T-lymfocyty imunologie MeSH
- herpes zoster prevence a kontrola MeSH
- lidé středního věku MeSH
- lidé MeSH
- počet CD4 lymfocytů MeSH
- proteiny virového obalu imunologie MeSH
- protilátky virové imunologie MeSH
- senioři MeSH
- subjednotkové vakcíny aplikace a dávkování škodlivé účinky imunologie MeSH
- vakcína proti pásovému oparu aplikace a dávkování škodlivé účinky imunologie MeSH
- virus varicella zoster imunologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví 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
- adjuvancia imunologická MeSH
- proteiny virového obalu MeSH
- protilátky virové MeSH
- subjednotkové vakcíny MeSH
- vakcína proti pásovému oparu MeSH
BACKGROUND: An adjuvanted varicella-zoster virus glycoprotein E (gE) subunit vaccine candidate for herpes zoster is in development. In this trial we compared the safety, reactogenicity, and immunogenicity of the vaccine antigen combined with different adjuvant doses. METHODS: This was a phase II, observer-blind, randomized, multinational study. Adults ≥50 years old were randomized 4:4:2:1 to be vaccinated at months 0 and 2 with gE combined with a higher (AS01B) or lower (AS01E) dose adjuvant, unadjuvanted gE, or saline. Following each dose, solicited events were recorded for 7 days and unsolicited adverse events for 30 days. Serious adverse events were collected for 1 year. Cell-mediated and humoral immune responses were assessed at baseline and following each dose. RESULTS: No vaccine-related severe adverse events were reported. Solicited adverse events were generally mild to moderate and transient. For all gE-based vaccines, pain was the most common local symptom and fatigue the most common general symptom. Immune responses were significantly enhanced by AS01B and AS01E compared to unadjuvanted gE and were significantly stronger for gE/AS01B than for gE/AS01E. CONCLUSIONS: AS01 improved the immunogenicity of gE while retaining acceptable safety and reactogenicity profiles. The enhancement of gE-specific cellular and humoral responses was adjuvant dose dependent. CLINICAL TRIALS REGISTRATION: NCT00802464.
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT00802464
