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BACKGROUND: The MenB-FHbp vaccine is licensed to prevent meningococcal serogroup B disease on either a 2-dose (0, 6 months) or 3-dose (0, 1-2, 6 months) series. This phase 3 study further assessed the immunogenicity and safety of the 2-dose MenB-FHbp schedule. METHODS: Subjects 10-25 years of age received MenB-FHbp (months 0, 6) and the quadrivalent meningococcal conjugate vaccine MenACWY-CRM (month 0). Primary immunogenicity endpoints included percentages of subjects achieving ≥ 4-fold increases from baseline in serum bactericidal antibody using human complement (hSBA) titers for 4 diverse, vaccine-heterologous primary serogroup B test strains and titers ≥ lower limit of quantitation (LLOQ; 1:8 or 1:16) for all 4 primary strains combined (composite response) after dose 2; a titer ≥ 1:4 is the accepted correlate of protection. Percentages of participants with hSBA titers ≥ LLOQ for 10 additional vaccine-heterologous strains were also assessed; positive predictive values of primary strain responses for secondary strain responses were determined. Safety was assessed. RESULTS: Overall, 1057 subjects received dose 1 and 946 received dose 2 of MenB-FHbp. Percentages of participants achieving ≥ 4-fold increases in hSBA titers against each primary strain after dose 2 ranged from 67.4% to 95.0% and the composite response was 74.3%. Primary strain responses were highly predictive of secondary strain responses. Most reactogenicity events were mild-to-moderate in severity and did not lead to withdrawal from the study. Adverse events (AEs) considered by the investigator to be related to vaccination occurred in 4.2% (44/1057) of subjects, and there were no serious AEs or newly diagnosed chronic medical conditions considered related to vaccination. CONCLUSIONS: MenB-FHbp administered at 0, 6 months was well tolerated and induced protective bactericidal antibody responses against diverse serogroup B strains. Findings provide further support for the continued use of MenB-FHbp on a 2-dose schedule in this population.

MeSH
lidé MeSH
meningokokové infekce * prevence a kontrola MeSH
meningokokové vakcíny * škodlivé účinky MeSH
mladiství MeSH
mladý dospělý MeSH
Neisseria meningitidis séroskupiny B * MeSH
Neisseria meningitidis * MeSH
protilátky bakteriální MeSH
séroskupina MeSH
vakcinace MeSH
Check Tag
lidé MeSH
mladiství MeSH
mladý dospělý MeSH
Publikační typ
časopisecké články MeSH
klinické zkoušky, fáze III MeSH
práce podpořená grantem MeSH

Článek online

Očkování pacientů s roztroušenou sklerózou
[Vaccination of patients with multiple sclerosis]

Neurologie pro praxi. 2022 ; 23 (5) : 395-399. [pub] 20221006

ISSN 1213-1814
Medvik
Zdroj

Pacienti s roztroušenou sklerózou mají kvůli základnímu onemocnění i jeho léčbě zvýšené riziko získání infekčních onemocnění a jejich komplikací, kterým je možné zabránit vakcinací. Vakcíny prokazatelně nezpůsobují ani nezhoršují průběh roztroušené sklerózy. Všichni pacienti s roztroušenou sklerózou by měli být řádně očkovaní podle indikací daných věkem a rizikovými faktory, včetně imunosupresivní léčby. Ta je ale kontraindikací podání živých očkovacích látek.

Patients with multiple sclerosis have an increased risk of acquiring and complications of vaccine-preventable infections caused by the underlying disease and its treatment. Vaccines have not been shown to cause or worsen the course of multiple sclerosis. All patients with multiple sclerosis should be properly vaccinated as indicated by age and risk factors, including immunosuppressive therapy. However, the latter is a contraindication to the administration of live vaccines.