A phase II, observer-blind, randomised, placebo-controlled, adjuvant-dose selection, multicenter prophylactic vaccination study to evaluate the immunogenicity and safety of GSK Biologicals’ herpes zoster vaccine, gE/AS01B, in comparison to gE combined with ½ dose AS01B adjuvant (gE/AS01E), to unadjuvanted gE (gE/Saline), and to Saline (placebo) when administered twice in subjects aged 50 years and older
Chlíbek, R., Smetana, J., Kalíšková, E., Vokurková, D.
Supported by the GlaxoSmithKline Biologicals co., 2009–2010 (Project No.: 112077 (Zoster-010))
Herpes zoster or shingles is caused by the reactivation of latent varicella-zoster virus (VZV). The incidence of HZ increases with age, presumably due to waning cellular immunity. GSK Biologicals’ candidate HZ vaccine, gE/AS01B, consisting of VZV glycoprotein E (gE) adjuvanted with AS01B has been evaluated in previous studies. The present study will provide comparative data concerning the immunogenicity and safety of 50 mg gE adjuvanted with different doses of AS01B, i.e., full dose AS01B, ½ dose AS01B (= AS01E), and no adjuvant when administered twice (Months 0 and 2) in adults ³ 50 YOA, and will include a Saline group as a negative control (placebo).
A phase II, single-blind, randomized, controlled, multicentre vaccination study to evaluate the safety and immune response of the GSK Biologicals Zoster vaccine, gE/AS01B, and to compare 3 doses of gE with AS01B adjuvant in healthy elderly subjects, aged 60 to 69 years and 70 years and above60 to 69 years and 70 years and above
Chlíbek, R., Kalíšková, E., Smetana, J.
Supported by the GlaxoSmithKline Biologicals co., 2007–2010 (Project No.: 108494, Zoster-003)
The safety and immunogenicity of the Varicella Zoster virus (VZV) gE (50 µg)/AS01B vaccine has been evaluated in a previous study. This study intends to compare the immunogenicity and safety of different doses of gE (25, 50 and 100 µg) with AS01B adjuvant and of different schedules of administration (1 vaccination with 100 µg of gE versus 2 vaccinations with different doses of gE) in the healthy elderly (? 70 years) population. Subjects aged 60-69 years will also be enrolled to evaluate the safety and immunogenicity of the vaccine formulations in that age group. A control group vaccinated with 100 µg gE antigen with saline will be included to support justification of the adjuvant.
A phase III, randomized, observer-blind, placebo controlled, multicentre, clinical vaccination trial to assess the prophylactic efficacy, safety and immunogenicity of GSK Biologicals’ herpes zoster gE/AS01B vaccine when administered intramuscularly on a 0, 2- month schedule in adults aged 70 years and older
Chlíbek, R., Kalíšková, E., Ditě, P., Vokurková, D., Smetana, J., Gál, P.
Supported by the GlaxoSmithKline Biologicals co., 2010–2015 (Project No.: 113077 (ZOSTER-022))
A phase III, randomized, observer-blind, placebo controlled, multicentre, clinical vaccination trial to assess the prophylactic efficacy, safety and immunogenicity of GSK Biologicals’ herpes zoster gE/AS01B vaccine when administered intramuscularly on a 0, 2- month schedule in adults aged 70 years and older. Chlíbek, R., Smetana, J., Gál, P., Dítě, P., Kalíšková, E., Vokurková, D. Supported by the GSK, 2010–2015 (Project No.: 113077 (ZOSTER-022) Study ZOSTER-022 will provide data on the vaccine efficacy in prevention of herpes zoster (HZ) and Postherpetic neuralgia (PHN) compared to placebo in adults ≥ 70 YOA. The ZOSTER-022 study will enrol subjects in the age ranges 70-79 YOA and ≥ 80 YOA in a 3:1 ratio.
A phase III, randomized, observer-blind, placebocontrolled, multicentre, clinical vaccination trial to assess the prophylactic efficacy, safety, and immunogenicity of GSK Biologicals´ herpes zoster gE/AS01B vaccine when administered intramuscularly on a 0, 2-month schedule in adults aged 50 years and older
Chlíbek, R., Vokurková, D., Dítě, P., Kalíšková, E., Smetana, J., Gál, P.
Supported by the GlaxoSmithKline Biologicals co., 2010–2015 (Project No.: 110390 (ZOSTER-006))
Study ZOSTER-006 will provide pivotal data on the overall efficacy in prevention of herpes zoster (HZ) in subjects ≥ 50 YOA. The primary endpoint of this study will be overall HZ vaccine efficacy (VE) across all age cohorts. To this end, ZOSTER-006 will evaluate VE of the gE/AS01B vaccine compared to placebo in reducing the risk of developing HZ in subjects ≥ 50 YOA. This study will enrol subjects in the age ranges 50-59 YOA, 60-69 YOA, 70-79 YOA and ≥ 80 YOA.
A phase 2 partially observer-blind randomized controlled multi-center dose-ranging and formulation-finding study of a new Novartis Meningococcal B Recombinant Vaccine evaluating the safety and immunogenicity when given concomitantly with routine vaccines in 2-month-old infants
Prymula, R., Chlíbek, R., Jarolímek, J., Slavík, Z., Karlová, V., Říhová, J., Hrunka, S., Novák, L.
Supported by the Novartis, 2009–2010 (Project No.: 2009-010106-11)
This study is aimed at assessing the safety and immunogenicity of different doses and formulations (including decreasing OMV contents) of a new Novartis Meningococcal B Recombinant Vaccine (rMenB + OMV NZ) in order to optimize its safety profile while maintaining sufficient immunogenicity. In addition, this study will assess whether prophylactic administration of paracetamol can decrease the incidence of febrile reactions following vaccination without impacting the immunogenicity of rMenB + OMV NZ and the routine infant vaccines. (V72P16)
A phase 2b, open label, multi-center, extension study to evaluate the safety, tolerability and immunogenicity of a booster dose of Novartis meningococcal B recombinant vaccine adminstered at 12, 18 or 24 months of age in subjects who perviously received a three-dose primary series of the Novartis meningococcal B recombinant vaccine as infants in study V72P12
Prymula, R., Chlíbek, R., Jerolímek, J., Slavík, Z., Karlová, V., Říhová, J., Hrunka, S., Novák, L.
Supported by the Novartis, 2010–2012 (Project No.: V72P12E1)
This extension study is designed to investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age.in subjects previously primed with rMenB+OMV NZ in the parent study V72P12 according to the two different three-dose immunization schedules in infancy (2, 3, 4 and 2, 4, 6 months of age) and for the 2, 4, 6 rMenB+OMV NZ schedule, according to two different immunization schedules for routine vaccines (concomitant with rMenB+OMV NZ and staggered).