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
Language English Country Netherlands Media print-electronic
Document type Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
24508036
DOI
10.1016/j.vaccine.2014.01.019
PII: S0264-410X(14)00051-6
Knihovny.cz E-resources
- Keywords
- Adjuvant, Herpes zoster, Vaccine, Varicella-zoster virus, gE,
- MeSH
- Adjuvants, Immunologic administration & dosage MeSH
- Immunity, Cellular * MeSH
- CD4-Positive T-Lymphocytes immunology MeSH
- Immunity, Humoral * MeSH
- Dose-Response Relationship, Immunologic MeSH
- Single-Blind Method MeSH
- Middle Aged MeSH
- Humans MeSH
- Immunization Schedule MeSH
- Antibodies, Viral blood MeSH
- Aged MeSH
- Vaccines, Subunit adverse effects immunology therapeutic use MeSH
- Herpes Zoster Vaccine adverse effects immunology therapeutic use 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
- Comparative Study MeSH
- Names of Substances
- Adjuvants, Immunologic MeSH
- Antibodies, Viral MeSH
- Vaccines, Subunit MeSH
- Herpes Zoster Vaccine MeSH
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 AS01B. METHODS: In this phase II, single-blind, randomized, controlled study, adults aged ≥60years (N=714) received one dose of 100μggE/AS01B, two doses, two months apart, of 25, 50, or 100μggE/AS01B, or two doses of unadjuvanted 100μggE/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/AS01B formulations than after one dose of 100μggE/AS01B or two doses of 100μggE/saline. Frequencies were comparable after two doses of 25, 50, or 100μggE/AS01B. Serum anti-gE antibody concentrations were comparable after two doses of 50 or 100μggE/AS01B and higher than in the other groups. Immune responses persisted for at least 36 months. Reactogenicities of all gE/AS01B formulations were similar but greater than with gE/saline. CONCLUSIONS: The three formulations of gE/AS01B were immunogenic and well tolerated in adults aged ≥60years. Two vaccinations with gE/AS01B induced higher immune responses than one and the dose of gE impacted humoral but not cellular immune responses (NCT00434577).
Central Laboratory and Vaccination Centre Stiftung Juliusspital Würzburg Germany
Faculty of Military Health Sciences University of Defence Hradec Kralove Czech Republic
GlaxoSmithKline Vaccines King of Prussia PA USA
GlaxoSmithKline Vaccines Wavre Belgium
Municipal Public Health Service Rotterdam Rijnmond Rotterdam The Netherlands
References provided by Crossref.org
ClinicalTrials.gov
NCT00434577
