ES2606545T3 - Método de almacenar una vacuna que contiene un adyuvante de aluminio - Google Patents

Método de almacenar una vacuna que contiene un adyuvante de aluminio Download PDF

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ES2606545T3
ES2606545T3 ES11772945.9T ES11772945T ES2606545T3 ES 2606545 T3 ES2606545 T3 ES 2606545T3 ES 11772945 T ES11772945 T ES 11772945T ES 2606545 T3 ES2606545 T3 ES 2606545T3
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syringes
desorption
months
hbsag
storing
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Isabelle Chacornac
Nabila Ikhelef-Gribi
Frédéric RONZON
Julien Tirefort
Sandrine Lentsch Graf
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Sanofi Pasteur Inc
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Abstract

Un recipiente para almacenar y/o administrar una composición de vacuna, en donde el recipiente contiene una composición de vacuna que comprende un antígeno de la hepatitis B adsorbido sobre un adyuvante de oxihidróxido de aluminio y está cerrado por un dispositivo que actúa como un tapón, en donde la superficie del dispositivo contactable con la composición está revestida con un polímero fluorado.

Description

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A T (tiempo) = 0, el nivel de adsorción de HbsAg era idéntico en las tres categorías (se adsorbió el 98% del total de HBsAg). A T = 2 meses se observó una desorción en todas las categorías, pero el porcentaje de desorción difería dependiendo de la categoría. El porcentaje de desorción más alto se encontró en la categoría (1) (a T = 1 y 2 meses, se adsorbió 55 y 50% del HBsAg total, respectivamente), mientras que el porcentaje más bajo se encontró en la categoría (3) (A T = 1 y 2 meses, se adsorbieron 72 y 69% del total de HBsAg, respectivamente).
B -Una gran parte de la composición de vacuna descrita en A -se distribuyó en dos categorías de una dosis única de jeringas de 1 mL, cuyas características eran las siguientes:
(1)
jeringas de vidrio siliconizadas estándares (silicona libre); y
(2)
jeringas no siliconizadas.
La mayor parte se distribuyó en dosis únicas de 0,5 mL, conteniendo cada una de las dosis 10 µg de HBsAg, 30 Lf de Dt, 10 Lf de Tt, 25 µg de Pt, 25 µg de FHA, 40 DU (Unidad de antígeno D) de IPV1, 8 DU de IPV2, 32 DU de IPV3, 12 µg de PRP (en forma conjugada PRP-Tt), 0,6 mg de Al, 55 mM de iones fosfato, 20 mM de iones carbonato y tampón Tris sacarosa, 2,5 mM, 2,125%, a pH 6,8-7,2.
Todas las jeringas de las dos categorías fueron almacenadas horizontalmente a 25°C durante dos meses (envejecimiento acelerado). La desorción de HBsAg se midió en cada una de las dos categorías a T = 0 (justo después de cargar las jeringas) y luego después de dos meses, tal como se describe en A -arriba.
A T (tiempo) = 0, el nivel de adsorción de HbsAg era idéntico en las dos categorías (se adsorbió el 98% del total de HBsAg). A T = 2 meses se observó una desorción en todas las categorías, pero el porcentaje de desorción difería dependiendo de la categoría. El porcentaje de desorción más alto se encontró en la categoría (1) (a T = 1 y 2 meses, se adsorbió 69 y 68% del HBsAg total, respectivamente), mientras que el porcentaje de desorción más bajo se encontró en la categoría (2) (A T = 1 y 2 meses, se adsorbió 73% del total de HBsAg). Esto indica claramente que la adsorción del antígeno sobre un adyuvante de aluminio es sensible a la silicona libre.
C -Una gran parte de la composición de la vacuna descrita en A -se distribuyó en tres tipos de jeringas de dosis única de 1 mL, cuyas características eran las siguientes:
(1)
jeringas de vidrio poco siliconizadas (50-100 µg de silicona libre/jeringa);
(2)
jeringas de vidrio altamente siliconizadas estándares ((jeringa RTF Luercone™ de Gerresheimer): 800 µg a 1 mg de silicona libre/jeringa); y
(3)
jeringas que tenían la superficie interior recubierta con silicona polimerizada (50-100 µg/jeringa).
Jeringas de la categoría (1) son operativas solamente si el émbolo utilizado para la inyección también está siliconizado, porque la cantidad de silicona que recubre la superficie interior de la jeringa es demasiado baja para permitir el deslizamiento por sí misma.
Todas las jeringas (tipos 1 a 3) se cerraron con el mismo tipo de tapón no siliconizado.
La vacuna a granel se distribuyó en dosis únicas de 0,5 mL, siendo cada una de las dosis como se describe en A y
B.
Todas las jeringas de los tres tipos fueron almacenadas verticalmente a 25°C durante dos meses (envejecimiento acelerado). La desorción de HBsAg se midió en cada uno de los tres tipos a T = 0 (justo después de llenar las jeringas) y luego después de dos meses, tal como se describe en A -arriba.
A T (tiempo) = 0, el nivel de adsorción de HbsAg era idéntico en los tres tipos (se adsorbió el 94% del total de HBsAg). A T = 2 meses, se observó una desorción en todas las jeringas, pero el porcentaje de desorción difería dependiendo del tipo. El porcentaje de desorción más alto se encontró en el tipo (2) (a T = 1 y 2 meses, se adsorbió 60 y 58% del HBsAg total, respectivamente), mientras que el porcentaje de desorción se encontró similar en los tipos
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Claims (1)

  1. imagen1
ES11772945.9T 2010-10-18 2011-10-17 Método de almacenar una vacuna que contiene un adyuvante de aluminio Active ES2606545T3 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
FR1058464A FR2966044B1 (fr) 2010-10-18 2010-10-18 Procede de conditionnement d'un vaccin contenant un adjuvant d'aluminium
FR1058464 2010-10-18
US201161454248P 2011-03-18 2011-03-18
US201161454248P 2011-03-18
PCT/EP2011/068090 WO2012052394A1 (en) 2010-10-18 2011-10-17 Method of storing a vaccine containing an aluminum adjuvant

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ES2606545T3 true ES2606545T3 (es) 2017-03-24

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