Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults=50 years of age
| Autor: | Roman Chlibek, Johann Mols, Edouard Ledent, Thomas C. Heineman, Maria Luisa Rodriguez de la Pinta, Harry Collins, José M Bayas |
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| Rok vydání: | 2013 |
| Předmět: |
CD4-Positive T-Lymphocytes
Male Herpesvirus 3 Human medicine.medical_treatment medicine.disease_cause Antibodies Viral Herpes Zoster Virus Immune system Adjuvants Immunologic Viral Envelope Proteins Immunology and Allergy Medicine Herpes Zoster Vaccine Humans Adverse effect Aged Reactogenicity business.industry Immunogenicity Varicella zoster virus Middle Aged Virology CD4 Lymphocyte Count Clinical trial Infectious Diseases Immunology Vaccines Subunit Female business Adjuvant |
| Zdroj: | The Journal of infectious diseases. 208(12) |
| ISSN: | 1537-6613 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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