Long-term immunogenicity and safety of an investigational herpes zoster subunit vaccine in older adults
Language English Country Netherlands Media print-electronic
Document type Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
26432913
DOI
10.1016/j.vaccine.2015.09.073
PII: S0264-410X(15)01349-3
Knihovny.cz E-resources
- Keywords
- Glycoprotein E, Immunogenicity, NCT01295320, Persistence, Subunit vaccine, Varicella-zoster virus,
- MeSH
- Immunity, Cellular * MeSH
- CD4-Positive T-Lymphocytes immunology MeSH
- Drug Combinations MeSH
- Herpes Zoster prevention & control MeSH
- Immunity, Humoral * MeSH
- Middle Aged MeSH
- Humans MeSH
- Lipid A administration & dosage analogs & derivatives MeSH
- Follow-Up Studies MeSH
- Viral Envelope Proteins immunology MeSH
- Antibodies, Viral blood MeSH
- Saponins administration & dosage MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Vaccines, Subunit immunology therapeutic use MeSH
- Herpes Zoster Vaccine immunology therapeutic use MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over 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
- adjuvant system 01 MeSH Browser
- Drug Combinations MeSH
- Lipid A MeSH
- Viral Envelope Proteins MeSH
- Antibodies, Viral MeSH
- Saponins MeSH
- Vaccines, Subunit MeSH
- Herpes Zoster Vaccine 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
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