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
| Autor: | Edouard Ledent, Jan Hendrik Richardus, Georg Plassmann, Thomas C. Heineman, Karlis Pauksens, Lars Rombo, J. Anneke R. Van den Hoek, Jan Smetana, Roman Chlibek, Tino F. Schwarz |
|---|---|
| Přispěvatelé: | Other departments, Public Health |
| Rok vydání: | 2014 |
| Předmět: |
CD4-Positive T-Lymphocytes
Male Herpes Zoster Vaccine medicine.medical_treatment Dose-Response Relationship Immunologic Pharmacology Antibodies Viral medicine.disease_cause Virus Immune system Adjuvants Immunologic SDG 3 - Good Health and Well-being medicine Humans Single-Blind Method Immunization Schedule Aged Immunity Cellular General Veterinary General Immunology and Microbiology biology business.industry Immunogenicity Public Health Environmental and Occupational Health Varicella zoster virus Middle Aged Virology Immunity Humoral Vaccination Infectious Diseases Vaccines Subunit biology.protein Molecular Medicine Female Antibody business Adjuvant |
| Zdroj: | Vaccine, 32(15), 1745-1753. Elsevier BV Vaccine, 32(15), 1745-1753. Elsevier |
| ISSN: | 0264-410X |
| Popis: | 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 ASO1(B). Methods: In this phase II, single-blind, randomized, controlled study, adults aged >= 60 years (N = 714) received one dose of 100 mu g gE/AS01(B), two doses, two months apart, of 25, 50, or 100 mu g gE/AS01(B), or two doses of unadjuvanted 100 mu g gE/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/AS01(B) formulations than after one dose of 100 mu g gE/AS01(B) or two doses of 100 mu g gE/saline. Frequencies were comparable after two doses of 25, 50, or 100 mu g gE/AS01g. Serum anti-gE antibody concentrations were comparable after two doses of 50 or 100 mu g gE/AS01(B) and higher than in the other groups. Immune responses persisted for at least 36 months. Reactogenicities of all gE/AS01(B) formulations were similar but greater than with gE/saline. Conclusions: The three formulations of gE/AS01(B) were immunogenic and well tolerated in adults aged >= 60 years. Two vaccinations with gE/AS01(B) induced higher immune responses than one and the dose of gE impacted humoral but not cellular immune responses (NCT00434577). (C) 2014 Elsevier Ltd. All rights reserved. |
| Databáze: | OpenAIRE |
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