Immunogenicity and safety of 11-and 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccines (11vPHiD-CV, 12vPHiD-CV) in infants: Results from a phase II, randomised, multicentre study
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11150%2F19%3A10398910" target="_blank" >RIV/00216208:11150/19:10398910 - isvavai.cz</a>
Výsledek na webu
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=ZB.mU0uNNX" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=ZB.mU0uNNX</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.vaccine.2018.07.023" target="_blank" >10.1016/j.vaccine.2018.07.023</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Immunogenicity and safety of 11-and 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccines (11vPHiD-CV, 12vPHiD-CV) in infants: Results from a phase II, randomised, multicentre study
Popis výsledku v původním jazyce
Background: We assessed 2 investigational 11- and 12-valent vaccines, containing capsular polysaccharides of 10 serotypes as in the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) and CRIA(197)-conjugated capsular polysaccharides of serotypes 19A (11-valent) or 19A and 6A (12-valent). Methods: In this phase II, partially-blind, multicentre study (NCT01204658), healthy infants were randomised (1:1:1:1) to receive 11vPHiD-CV, 12vPHiD-CV, PHiD-CV, or 13-valent CRM197-conjugate pneumococcal vaccine (PCV13), at 2, 3, and 4 (primary series), and 12-15 months of age (booster dose), co-administered with DTPa-HBV-IPV/Hib. Confirmatory objectives assessed non-inferiority of investigational vaccines to comparators (PHiD-CV for common serotypes; PCV13 for 19A and 6A), in terms of percentage of infants with pneumococcal antibody concentrations >= 0.2 mu g/mL and antibody geometric mean concentrations, post-primary vaccination. Reactogenicity and safety were assessed. Results: 951 children received >= 1 primary dose, 919 a booster dose. Pre-defined immunological non inferiority criteria were met simultaneously for 9/11 11vPHiD-CV serotypes (all except 23F and 19A) and 10/12 12vPHiD-CV serotypes (all except 19A and 6A); thus, non-inferiority objectives were reached. For each PHiD-CV serotype, percentages of children with antibody concentrations >= 0.2 AgirnL were >96.7% post-primary (except 6B [>= 75.2%] and 23F [>= 81.1%]), and >= 98.1% post-booster vaccination. For each PHiD-CV serotype except serotype 1, >= 81.0% and >= 93.9% of children had opsonophagocytic activity titres >= 8, post-primary and booster vaccination. AEs incidence was similar across all groups. SAEs were reported for 117 children (29 in the 11vPHiD-CV group, 26 in the 12vPHiD-CV group, 38 in the PHiD-CV group and 24 in the PCV13 group); 4 SAEs were considered vaccination-related. No fatal events were recorded. Conclusion: Addition of 19A and 6A CRM197-conjugates did not alter immunogenicity of the PHiD-CV conjugates; for both investigational vaccines post-booster immune responses to 10 common serotypes appeared similar to those elicited by PHiD-CV. Safety and reactogenicity profiles of the investigational vaccines were comparable to PHiD-CV. (C) 2018 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license.
Název v anglickém jazyce
Immunogenicity and safety of 11-and 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccines (11vPHiD-CV, 12vPHiD-CV) in infants: Results from a phase II, randomised, multicentre study
Popis výsledku anglicky
Background: We assessed 2 investigational 11- and 12-valent vaccines, containing capsular polysaccharides of 10 serotypes as in the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) and CRIA(197)-conjugated capsular polysaccharides of serotypes 19A (11-valent) or 19A and 6A (12-valent). Methods: In this phase II, partially-blind, multicentre study (NCT01204658), healthy infants were randomised (1:1:1:1) to receive 11vPHiD-CV, 12vPHiD-CV, PHiD-CV, or 13-valent CRM197-conjugate pneumococcal vaccine (PCV13), at 2, 3, and 4 (primary series), and 12-15 months of age (booster dose), co-administered with DTPa-HBV-IPV/Hib. Confirmatory objectives assessed non-inferiority of investigational vaccines to comparators (PHiD-CV for common serotypes; PCV13 for 19A and 6A), in terms of percentage of infants with pneumococcal antibody concentrations >= 0.2 mu g/mL and antibody geometric mean concentrations, post-primary vaccination. Reactogenicity and safety were assessed. Results: 951 children received >= 1 primary dose, 919 a booster dose. Pre-defined immunological non inferiority criteria were met simultaneously for 9/11 11vPHiD-CV serotypes (all except 23F and 19A) and 10/12 12vPHiD-CV serotypes (all except 19A and 6A); thus, non-inferiority objectives were reached. For each PHiD-CV serotype, percentages of children with antibody concentrations >= 0.2 AgirnL were >96.7% post-primary (except 6B [>= 75.2%] and 23F [>= 81.1%]), and >= 98.1% post-booster vaccination. For each PHiD-CV serotype except serotype 1, >= 81.0% and >= 93.9% of children had opsonophagocytic activity titres >= 8, post-primary and booster vaccination. AEs incidence was similar across all groups. SAEs were reported for 117 children (29 in the 11vPHiD-CV group, 26 in the 12vPHiD-CV group, 38 in the PHiD-CV group and 24 in the PCV13 group); 4 SAEs were considered vaccination-related. No fatal events were recorded. Conclusion: Addition of 19A and 6A CRM197-conjugates did not alter immunogenicity of the PHiD-CV conjugates; for both investigational vaccines post-booster immune responses to 10 common serotypes appeared similar to those elicited by PHiD-CV. Safety and reactogenicity profiles of the investigational vaccines were comparable to PHiD-CV. (C) 2018 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license.
Klasifikace
Druh
J<sub>imp</sub> - Článek v periodiku v databázi Web of Science
CEP obor
—
OECD FORD obor
30102 - Immunology
Návaznosti výsledku
Projekt
—
Návaznosti
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Ostatní
Rok uplatnění
2019
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
Vaccine
ISSN
0264-410X
e-ISSN
—
Svazek periodika
37
Číslo periodika v rámci svazku
1
Stát vydavatele periodika
GB - Spojené království Velké Británie a Severního Irska
Počet stran výsledku
11
Strana od-do
176-186
Kód UT WoS článku
000454374100025
EID výsledku v databázi Scopus
2-s2.0-85057548557