Varicella vaccine without human serum albumin versus licensed varicella vaccine in children during the second year of life: a randomized, double-blind, non-inferiority trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60162694%3AG44__%2F16%3A43875552" target="_blank" >RIV/60162694:G44__/16:43875552 - isvavai.cz</a>

Výsledek na webu

<a href="http://bmcpediatr.biomedcentral.com/articles/10.1186/s12887-016-0546-5" target="_blank" >http://bmcpediatr.biomedcentral.com/articles/10.1186/s12887-016-0546-5</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1186/s12887-016-0546-5" target="_blank" >10.1186/s12887-016-0546-5</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Varicella vaccine without human serum albumin versus licensed varicella vaccine in children during the second year of life: a randomized, double-blind, non-inferiority trial

Popis výsledku v původním jazyce

GSK's varicella vaccine contains HSA which is used to stabilize the virus and prevent immunogens from adhering to the injection vial walls. Because HSA is derived from human blood, there is a theoretical risk that it might contain infectious agents which could be unsafe for humans. Given this concern, a study was undertaken to compare the immunogenicity and safety of a new formulation without HSA with the currently licensed varicella vaccine in the CZ and Hungary. Healthy children aged 11-21 months received 2 doses of the varicella vaccine either with or without HSA. Antibody anti-VZV were measured 42 days after each dose, using an immunofluorescence assay and enzyme linked immunosorbent assay. Solicited local symptoms were recorded during a 4-day post-vaccination follow-up period; solicited general and unsolicited symptoms were recorded during a 43-day post-vaccination follow-up.Of 244 children, 233 (without HSA N=117; containing HSA N=116) formed the according-to-protocol immunogenicity cohort. Seroconversion/seroresponse rates were >98 and 100 %, 42 days after doses 1 and 2, respectively. The rates were within the same range in both groups, irrespective of the testing assay. The vaccine without HSA was non-inferior to the licensed vaccine in terms of anti-VZV antibody Geometric Mean Titre/Conc. ratio (1.12 [95 % CI:0.86-1.46] by IFA; 1.12 [95 % CI: 0.93-1.33] by ELISA) approximately 6x weeks after the 1st dose of the 2-dose vaccination course. The incidence of solicited and unsolicited symptoms was similar after both vaccines; low-grade fever was numerically higher after the 1st dose without HSA. Seven SAEs were reported, none of which were fatal or considered to be vaccine-related. The 1st dose of a new varicella vaccine without HSA was immunologically non-inferior to the licensed varicella vaccine. After 2 doses, both vaccines had acceptable safety profiles in children aged 11-21 months in the CZ and Hungary.

Název v anglickém jazyce

Varicella vaccine without human serum albumin versus licensed varicella vaccine in children during the second year of life: a randomized, double-blind, non-inferiority trial

Popis výsledku anglicky

GSK's varicella vaccine contains HSA which is used to stabilize the virus and prevent immunogens from adhering to the injection vial walls. Because HSA is derived from human blood, there is a theoretical risk that it might contain infectious agents which could be unsafe for humans. Given this concern, a study was undertaken to compare the immunogenicity and safety of a new formulation without HSA with the currently licensed varicella vaccine in the CZ and Hungary. Healthy children aged 11-21 months received 2 doses of the varicella vaccine either with or without HSA. Antibody anti-VZV were measured 42 days after each dose, using an immunofluorescence assay and enzyme linked immunosorbent assay. Solicited local symptoms were recorded during a 4-day post-vaccination follow-up period; solicited general and unsolicited symptoms were recorded during a 43-day post-vaccination follow-up.Of 244 children, 233 (without HSA N=117; containing HSA N=116) formed the according-to-protocol immunogenicity cohort. Seroconversion/seroresponse rates were >98 and 100 %, 42 days after doses 1 and 2, respectively. The rates were within the same range in both groups, irrespective of the testing assay. The vaccine without HSA was non-inferior to the licensed vaccine in terms of anti-VZV antibody Geometric Mean Titre/Conc. ratio (1.12 [95 % CI:0.86-1.46] by IFA; 1.12 [95 % CI: 0.93-1.33] by ELISA) approximately 6x weeks after the 1st dose of the 2-dose vaccination course. The incidence of solicited and unsolicited symptoms was similar after both vaccines; low-grade fever was numerically higher after the 1st dose without HSA. Seven SAEs were reported, none of which were fatal or considered to be vaccine-related. The 1st dose of a new varicella vaccine without HSA was immunologically non-inferior to the licensed varicella vaccine. After 2 doses, both vaccines had acceptable safety profiles in children aged 11-21 months in the CZ and Hungary.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FN - Epidemiologie, infekční nemoci a klinická imunologie

OECD FORD obor

—

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2016

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

BMC Pediatrics

ISSN

1471-2431

e-ISSN

—

Svazek periodika

16

Číslo periodika v rámci svazku

Jan

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

7

Strana od-do

"Article Number: 7"

Kód UT WoS článku

000368065600001

EID výsledku v databázi Scopus

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