BACKGROUND: Meningococcal serogroup B (MenB) strains are highly diverse. Breadth of immune response for the MenB vaccine, 4CMenB, administered at 0-2, 0-6, or 0-2-6 months, was demonstrated by endogenous complement-human serum bactericidal antibody (enc-hSBA) assay against an epidemiologically relevant panel of 110 MenB strains. METHODS: In a phase 3 trial, 3651 healthy 10- to 25-year-old participants were randomized 5:5:9:1 to receive 4CMenB (0-6 schedule), 4CMenB (0-2-6 schedule), investigational MenABCWY vaccine, or control MenACWY-CRM vaccine. The primary objectives were to evaluate safety and demonstrate breadth of immune response by enc-hSBA assay against the MenB strain panel using test-based (percentage of samples without bactericidal activity against strains after 4CMenB vs control vaccination) and responder-based (percentage of participants whose postvaccination sera kill ≥70% strains) approaches. Success was demonstrated with 2-sided 97.5% confidence interval (CI) lower limit >65%. Immunogenicity was assessed by traditional hSBA assay against four indicator strains. RESULTS: Breadth of immune response (test-based) was 78.7% (97.5% CI, 77.2-80.1), 81.8% (80.4-83.1), 83.2% (81.9-84.4) for the 0-2, 0-6, and 0-2-6 schedules, respectively, and (responder-based) 84.8% (81.8-87.5), 89.8% (87.2-92.0), and 93.4% (91.2-95.2), respectively. No clinically relevant differences in immunogenicity were observed across schedules. 4CMenB was well tolerated. CONCLUSIONS: The 2-dose (0-2, 0-6) 4CMenB schedules met predefined criteria for success for both breadth of immune response endpoints against a diverse MenB strain panel, had comparable immunogenicity, and safety in line with the established 4CMenB safety profile. The 3-dose schedule provided no additional immunological benefit, supporting use of the 4CMenB 0-2 schedule.

• Publikační typ
• časopisecké články MeSH
• klinické zkoušky MeSH

Sborník prací, které se zaměřily na zdraví a sociální aspekty současného lékařství a zdravotního systému. Určeno odborné veřejnosti.

• MeSH
• dějiny lékařství MeSH
• komplementární terapie MeSH
• lékařství MeSH
• poskytování zdravotní péče MeSH
• sociální faktory MeSH
• zdraví MeSH
• Publikační typ
• sborníky MeSH

• Konspekt
• Veřejné zdraví a hygiena
• NLK Obory
• veřejné zdravotnictví
• NLK Publikační typ
• kolektivní monografie

BACKGROUND: Vaccination is the best mode of protection against tick-borne encephalitis (TBE) and its sequelae. The duration of protection and the optimal interval of repeat booster doses are still debated. The current study evaluated the persistence of the antibody response 11-15 years after a first booster vaccination following different primary vaccination schedules with a TBE vaccine (Encepur Adults, manufactured by Bavarian Nordic, previously by GSK). METHODS: This phase IV, open-label, mono-centric extension study enrolled adults who had received (at ≥ 12 years of age) primary vaccination with one of three randomly assigned TBE vaccine schedules (rapid [group R], conventional [group C], or accelerated conventional schedule [group A]) followed by a booster dose 3 years later. The antibody response was measured annually from 11 to 15 years post-booster using a TBE virus neutralization test (NT). An NT titer of ≥ 10 was considered as a clinically meaningful threshold and surrogate for protection. RESULTS: In total, 194 participants were enrolled and included in the per-protocol set; 188 completed the study. The percentage of participants with an NT titer ≥ 10 was 100% in group R and 99.0% in group A at all visits and ranged from 100% (year 11) to 95.8% (year 15) in group C. NT geometric mean titers were similar in the three study groups (181-267 in group R, 142-227 in group C, 141-209 in group A). NT geometric mean titers also remained high among participants ≥ 50 years old (98-206) and ≥ 60 years old (91-191) across study groups and time points. CONCLUSIONS: This study showed neutralizing antibody persistence for at least 15 years after a first booster dose of the Encepur Adults TBE vaccine in all age groups evaluated, regardless of which primary vaccination schedule was given to adolescents or adults. Trialregistry: ClinicalTrials.gov: NCT03294135.

• MeSH
• dospělí MeSH
• klíšťová encefalitida * prevence a kontrola   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• následné studie MeSH
• očkovací schéma MeSH
• předškolní dítě MeSH
• protilátky virové MeSH
• sekundární imunizace MeSH
• vakcinace MeSH
• virové vakcíny * MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• předškolní dítě MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze IV MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

Sborník osobních vzpomínek mnoha českých osobností na pandemii COVID-19. Určeno odborné i široké veřejnosti.

• MeSH
• COVID-19 MeSH
• dějiny 21. století MeSH
• právní vědy MeSH
• sociální změna MeSH
• sociologické faktory MeSH
• věda MeSH
• veřejné zdravotnictví MeSH
• Check Tag
• dějiny 21. století MeSH
• Publikační typ
• osobní vyprávění MeSH
• populární práce MeSH
• sborníky MeSH
• Geografické názvy
• Česká republika MeSH

• Konspekt
• Sociální procesy
• NLK Obory
• veřejné zdravotnictví
• sociologie

Příručka, která odpovídá na nejčastěnjší otázky spojené s očkováním a vakcínami. Určeno široké veřejnosti.

• MeSH
• cestovní lékařství MeSH
• dítě MeSH
• nežádoucí účinky léčiv MeSH
• vakcinace * MeSH
• vakcíny MeSH
• Check Tag
• dítě MeSH
• Publikační typ
• populární práce MeSH
• příručky MeSH

• Konspekt
• Veřejné zdraví a hygiena
• NLK Obory
• preventivní medicína
• zdravotní výchova
• NLK Publikační typ
• otázky a odpovědi

• MeSH
• infekční nemoci * MeSH
• kontrola infekčních nemocí MeSH
• lidé MeSH
• vakcinace MeSH
• Check Tag
• lidé MeSH

• MeSH
• COVID-19 * prevence a kontrola   MeSH
• lidé MeSH
• SARS-CoV-2 genetika   MeSH
• virové vakcíny * imunologie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• komentáře MeSH
• úvodníky MeSH

This phase 2, randomized, open-label study assessed the immunogenicity and safety of an investigational meningococcal ABCWY vaccine (MenABCWY) that contains components of licensed vaccines against meningococcal serogroup B (4CMenB) and serogroups ACWY (MenACWY). A total of 500 healthy 10- to 25-year-old participants were randomly assigned to one of five study groups in a 1:1:1:1:1 ratio. Four groups received two doses 2 months apart of MenABCWY and 4CMenB plus MenACWY administered concomitantly in the same arm (4CMenB+ACWY/S group) or different arms (4CMenB+ACWY/D group) or 4CMenB administered alone. A fifth group received a single MenACWY dose. Immunogenicity was determined by serum bactericidal assay using human complement (hSBA). The study was powered to assess immunological interference against pooled serogroup B test strains. One month after the second vaccine dose, hSBA geometric mean titers (GMTs) (with 80% confidence intervals [CI]) against pooled serogroup B strains were 31.84 (80% CI, 28.18 to 35.98), 38.48 (80% CI, 34.23 to 43.26), 40.08 (80% CI, 35.44 to 45.33), and 42.38 (80% CI, 37.31 to 48.13) in the MenABCWY, 4CMenB+ACWY/S, 4CMenB+ACWY/D, and 4CMenB groups, respectively. Immune responses (GMTs and 80% CIs) were lower for PorA and NHBA serogroup B test strains in the MenABCWY group compared to the 4CMenB+ACWY/D group and 4CMenB group. Evaluation of solicited and unsolicited adverse events (AEs) identified no safety concerns for the MenABCWY vaccine. One serious AE (syncope in the 4CMenB group) was considered related to vaccination. In conclusion, there is no evidence of substantial immunological interference between 4CMenB and MenACWY vaccine components against serogroup B. The safety and tolerability profile of the investigational MenABCWY vaccine was acceptable. (This study has been registered at ClinicalTrials.gov under registration no. NCT03587207.) IMPORTANCE The bacterial species Neisseria meningitidis is a major cause of meningitis, with six meningococcal groups (serogroups) causing most cases. A licensed vaccine, MenACWY (Menveo), targets four of these meningococcal serogroups, and another vaccine, 4CMenB (Bexsero), targets serogroup B. A combined vaccine (MenABCWY) that targets all five serogroups is under development to simplify the vaccination schedule. In a previous study, the immune response to serogroup B was found to be overall higher in individuals who received 4CMenB than in those who received an investigational MenABCWY vaccine. We investigated this further by giving healthy adolescents and young adults the MenABCWY vaccine, 4CMenB plus MenACWY vaccine in the same or different arms, 4CMenB vaccine alone, or MenACWY vaccine alone. Immunogenicity results for serogroup B across study groups suggest no major interference between the MenB and MenACWY vaccine components. This supports further development of the combined MenABCWY vaccine.

• MeSH
• baktericidní aktivita krve MeSH
• dítě MeSH
• léky zkušební aplikace a dávkování   škodlivé účinky   MeSH
• lidé MeSH
• meningokokové vakcíny aplikace a dávkování   škodlivé účinky   imunologie   MeSH
• mladiství MeSH
• mladý dospělý MeSH
• nežádoucí účinky léčiv epidemiologie   patologie   MeSH
• séroskupina MeSH
• vakcíny konjugované aplikace a dávkování   škodlivé účinky   imunologie   MeSH
• zdraví dobrovolníci pro lékařské studie MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH

Since its licensing in 1971, the synthetic compound inosine pranobex has been effectively combating viral infections, including herpes zoster, varicella, measles, and infections caused by the herpes simplex virus, human papillomavirus, Epstein-Barr virus, cytomegalovirus, and respiratory viruses. With the emergence of SARS-CoV-2, new and existing drugs have been intensively evaluated for their potential as COVID-19 medication. Due to its potent immunomodulatory properties, inosine pranobex, an orally administered drug with pleiotropic effects, can, during early treatment, alter the course of the disease. We describe the action of inosine pranobex in the body and give an overview of existing evidence collected to support further efforts to study this drug in a rigorous clinical trial setup.

• MeSH
• antivirové látky terapeutické užití   MeSH
• buňky NK imunologie   MeSH
• COVID-19 komplikace   imunologie   MeSH
• cytotoxické T-lymfocyty imunologie   MeSH
• farmakoterapie COVID-19 MeSH
• imunomodulační látky farmakologie   terapeutické užití   MeSH
• inosin pranobex farmakologie   terapeutické užití   MeSH
• klinické zkoušky jako téma MeSH
• lidé MeSH
• lymfopenie MeSH
• přehodnocení terapeutických indikací léčivého přípravku MeSH
• přirozená imunita MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• přehledy MeSH