Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults >=50 years of age
Language English Country United States Media print-electronic
Document type Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
23904292
DOI
10.1093/infdis/jit365
PII: jit365
Knihovny.cz E-resources
- Keywords
- adjuvant, immunogenicity, recombinant subunit vaccine, safety, varicella-zoster virus,
- MeSH
- Adjuvants, Immunologic MeSH
- CD4-Positive T-Lymphocytes immunology MeSH
- Herpes Zoster prevention & control MeSH
- Middle Aged MeSH
- Humans MeSH
- CD4 Lymphocyte Count MeSH
- Viral Envelope Proteins immunology MeSH
- Antibodies, Viral immunology MeSH
- Aged MeSH
- Vaccines, Subunit administration & dosage adverse effects immunology MeSH
- Herpes Zoster Vaccine administration & dosage adverse effects immunology MeSH
- Herpesvirus 3, Human immunology MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Adjuvants, Immunologic MeSH
- Viral Envelope Proteins MeSH
- Antibodies, Viral MeSH
- Vaccines, Subunit MeSH
- Herpes Zoster Vaccine 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.
References provided by Crossref.org
ClinicalTrials.gov
NCT00802464
