One or two doses of live varicella virus-containing vaccines: Efficacy, persistence of immune responses, and safety six years after administration in healthy children during their second year of life

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11140%2F18%3A10361555" target="_blank" >RIV/00216208:11140/18:10361555 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1016/j.vaccine.2017.11.081" target="_blank" >http://dx.doi.org/10.1016/j.vaccine.2017.11.081</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.vaccine.2017.11.081" target="_blank" >10.1016/j.vaccine.2017.11.081</a>

Jazyk výsledku

angličtina

Název v původním jazyce

One or two doses of live varicella virus-containing vaccines: Efficacy, persistence of immune responses, and safety six years after administration in healthy children during their second year of life

Popis výsledku v původním jazyce

Background: This phase III B follow-up of an initial multicenter study (NCT00226499) will evaluate the ten-year efficacy of two doses of the combined measles-mumps-rubella varicella vaccine (MMRV) and one dose of the live attenuated varicella vaccine (V) versus a measles-mumps-rubella control group (MMR) for the prevention of clinical varicella disease. Here we present efficacy results for six years post-vaccination. Methods: In phase A of the study, healthy children aged 12-22 months from ten European countries were randomized (3:3:1) and received either two doses of MMRV, or one dose of combined MMR and one dose of monovalent varicella vaccine (MMR+V), or two doses of the MMR vaccine (control), 42 days apart. Vaccine efficacy against all and against moderate or severe varicella (confirmed by detection of viral DNA or epidemiological link) was assessed from six weeks up to six years post-dose 2 for the MMRV and MMR+V groups, and was calculated with 95% confidence intervals (CI). The severity of varicella was calculated using the modified Vasquez scale (mildLESS-THAN OR EQUAL TO7; moderately severe=8-15; severeGREATER-THAN OR EQUAL TO16). Herpes zoster cases were also recorded. Results: 5289 children (MMRV=2279, mean age=14.2, standard deviation [SD]=2.5; MMR+V=2266, mean age=14.2, SD=2.4; MMR=744 mean age=14.2, SD=2.5 months) were included in the efficacy cohort. 815 varicella cases were confirmed. Efficacy of two doses of MMRV against all and against moderate or severe varicella was 95.0% (93,6-96,2) and 99.0% (97.7-99.6), respectively. Efficacy of one dose of varicella vaccine against all and against moderate or severe varicella was 67.0% (95%CI: 61.8-71.4) and 90.3% (95%CI: 86.9-92.8), respectively. There were four confirmed herpes zoster cases (MMR+V=2, MMR=2), all were mild and three tested positive for the wild-type virus.Conclusions: Two doses of the MMRV vaccine and one dose of the varicella vaccine remain efficacious through six years post-vaccination.

Název v anglickém jazyce

One or two doses of live varicella virus-containing vaccines: Efficacy, persistence of immune responses, and safety six years after administration in healthy children during their second year of life

Popis výsledku anglicky

Background: This phase III B follow-up of an initial multicenter study (NCT00226499) will evaluate the ten-year efficacy of two doses of the combined measles-mumps-rubella varicella vaccine (MMRV) and one dose of the live attenuated varicella vaccine (V) versus a measles-mumps-rubella control group (MMR) for the prevention of clinical varicella disease. Here we present efficacy results for six years post-vaccination. Methods: In phase A of the study, healthy children aged 12-22 months from ten European countries were randomized (3:3:1) and received either two doses of MMRV, or one dose of combined MMR and one dose of monovalent varicella vaccine (MMR+V), or two doses of the MMR vaccine (control), 42 days apart. Vaccine efficacy against all and against moderate or severe varicella (confirmed by detection of viral DNA or epidemiological link) was assessed from six weeks up to six years post-dose 2 for the MMRV and MMR+V groups, and was calculated with 95% confidence intervals (CI). The severity of varicella was calculated using the modified Vasquez scale (mildLESS-THAN OR EQUAL TO7; moderately severe=8-15; severeGREATER-THAN OR EQUAL TO16). Herpes zoster cases were also recorded. Results: 5289 children (MMRV=2279, mean age=14.2, standard deviation [SD]=2.5; MMR+V=2266, mean age=14.2, SD=2.4; MMR=744 mean age=14.2, SD=2.5 months) were included in the efficacy cohort. 815 varicella cases were confirmed. Efficacy of two doses of MMRV against all and against moderate or severe varicella was 95.0% (93,6-96,2) and 99.0% (97.7-99.6), respectively. Efficacy of one dose of varicella vaccine against all and against moderate or severe varicella was 67.0% (95%CI: 61.8-71.4) and 90.3% (95%CI: 86.9-92.8), respectively. There were four confirmed herpes zoster cases (MMR+V=2, MMR=2), all were mild and three tested positive for the wild-type virus.Conclusions: Two doses of the MMRV vaccine and one dose of the varicella vaccine remain efficacious through six years post-vaccination.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30304 - Public and environmental health

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2018

Kód důvěrnosti údajů

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

Název periodika

Vaccine

ISSN

0264-410X

e-ISSN

—

Svazek periodika

36

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

7

Strana od-do

381-387

Kód UT WoS článku

000429509600007

EID výsledku v databázi Scopus

2-s2.0-85040769987