BACKGROUND: Herpes zoster (HZ) vaccines should provide durable protection against HZ and HZ-related complications. We report the final analysis of a long-term follow-up (LTFU) study (ZOE-LTFU) including 11 years of follow-up after primary vaccination with recombinant zoster vaccine (RZV). METHODS: ZOE-LTFU (NCT02723773) was an open-label, phase 3b study following participants of two phase 3 trials, ZOE-50 and ZOE-70. ZOE-LTFU started approximately 5 years post-vaccination in ZOE-50/70 and participants were followed for 6 years. The primary objective was to assess vaccine efficacy (VE) against HZ during ZOE-LTFU. Secondary objectives included VE against HZ from 1 month post-dose 2 in ZOE-50/70 until end of ZOE-LTFU, VE against post-herpetic neuralgia (PHN) and non-PHN complications, immunogenicity, and long-term safety. The VE calculation used a historical control constructed with ZOE-50/70 placebo data. FINDINGS: VE was assessed in the modified total vaccinated cohort (n = 7273 [mean age 67·3 years at first vaccination]). During ZOE-LTFU, VE was 79·8% (95% confidence interval [CI]: 73·7, 84·6) and 73·2% (95% CI: 62·9, 80·9) against HZ in participants ≥50 and ≥70 years at first vaccination, respectively, and was 87·5% (95% CI: 64·8, 96·8) against PHN and 91·7% (95% CI: 43·7, 99·8) against other HZ-related complications in participants ≥50 years. From 1 month post-dose 2 in ZOE-50/70 to the end of ZOE-LTFU, VE against HZ was 87·7% (95% CI: 84·9, 90·1) in participants ≥50 years and sustained at 82·0% (95% CI: 63·0, 92·2) in the eleventh year post-vaccination. Humoural and cell-mediated immune responses plateaued at over 5-fold and ∼7-fold, respectively, above pre-vaccination levels in ZOE-50/70. No RZV-related serious adverse events occurred. INTERPRETATION: Efficacy of RZV against HZ and associated complications remained high through 11 years post-vaccination, indicating sustained clinical benefit. FUNDING: The funder of the study was GSK who was involved in study design, data collection, data analysis, data interpretation, writing of the report, and the decision to submit for publication.

• Klíčová slova
• Herpes zoster, Long-term follow-up, Post-herpetic neuralgia, Recombinant zoster vaccine,
• Publikační typ
• časopisecké články MeSH

During the last few years, several new drugs have been introduced for treatment of patients with multiple myeloma, which have significantly improved the treatment outcome. All of these novel substances differ at least in part in their mode of action from similar drugs of the same drug class, or are representatives of new drug classes, and as such present with very specific side effect profiles. In this review, we summarize these adverse events, provide information on their prevention, and give practical guidance for monitoring of patients and for management of adverse events.

• MeSH
• cílená molekulární terapie škodlivé účinky   MeSH
• hodnocení rizik MeSH
• incidence MeSH
• lidé MeSH
• management nemoci MeSH
• mnohočetný myelom komplikace   farmakoterapie   MeSH
• nežádoucí účinky léčiv diagnóza   epidemiologie   prevence a kontrola   terapie   MeSH
• protinádorové látky škodlivé účinky   terapeutické užití   MeSH
• směrnice pro lékařskou praxi jako téma MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• konsensus - konference MeSH
• přehledy MeSH
• Názvy látek
• protinádorové látky MeSH

BACKGROUND: The herpes zoster subunit vaccine (HZ/su), consisting of varicella-zoster virus glycoprotein E (gE) and AS01B Adjuvant System, was highly efficacious in preventing herpes zoster in the ZOE-50 and ZOE-70 trials. We present immunogenicity results from those trials. METHODS: Participants (ZOE-50: ≥50; ZOE-70: ≥70 years of age) received 2 doses of HZ/su or placebo, 2 months apart. Serum anti-gE antibodies and CD4 T cells expressing ≥2 of 4 activation markers assessed (CD42+) after stimulation with gE-peptides were measured in subcohorts for humoral (n = 3293) and cell-mediated (n = 466) immunogenicity. RESULTS: After vaccination, 97.8% of HZ/su and 2.0% of placebo recipients showed a humoral response. Geometric mean anti-gE antibody concentrations increased 39.1-fold and 8.3-fold over baseline in HZ/su recipients at 1 and 36 months post-dose 2, respectively. A gE-specific CD42+ T-cell response was shown in 93.3% of HZ/su and 0% of placebo recipients. Median CD42+ T-cell frequencies increased 24.6-fold (1 month) and 7.9-fold (36 months) over baseline in HZ/su recipients and remained ≥5.6-fold above baseline in all age groups at 36 months. The proportion of CD4 T cells expressing all 4 activation markers increased over time in all age groups. CONCLUSIONS: Most HZ/su recipients developed robust immune responses persisting for 3 years following vaccination. CLINICAL TRIALS REGISTRATION: NCT01165177; NCT01165229.

• MeSH
• adjuvancia imunologická farmakologie   MeSH
• buněčná imunita imunologie   MeSH
• CD4-pozitivní T-lymfocyty MeSH
• herpes zoster imunologie   MeSH
• humorální imunita imunologie   MeSH
• imunogenicita vakcíny imunologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• lipid A analogy a deriváty   farmakologie   MeSH
• proteiny virového obalu imunologie   MeSH
• protilátky virové imunologie   MeSH
• saponiny farmakologie   MeSH
• senioři MeSH
• subjednotkové vakcíny imunologie   MeSH
• vakcína proti pásovému oparu imunologie   MeSH
• vakcinace metody   MeSH
• virus varicella zoster imunologie   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• adjuvancia imunologická MeSH
• AS01B adjuvant MeSH Prohlížeč
• glycoprotein E, varicella-zoster virus MeSH Prohlížeč
• lipid A MeSH
• proteiny virového obalu MeSH
• protilátky virové MeSH
• saponiny MeSH
• subjednotkové vakcíny MeSH
• vakcína proti pásovému oparu MeSH