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ES2588183T3 - Procedimiento para la prevención de la gripe utilizando una vacuna para administración intranasal - Google Patents

Procedimiento para la prevención de la gripe utilizando una vacuna para administración intranasal Download PDF

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Publication number
ES2588183T3
ES2588183T3 ES10714104.6T ES10714104T ES2588183T3 ES 2588183 T3 ES2588183 T3 ES 2588183T3 ES 10714104 T ES10714104 T ES 10714104T ES 2588183 T3 ES2588183 T3 ES 2588183T3
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Prior art keywords
vaccine
antigen
influenza
prevention
procedure
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English (en)
Inventor
Hideki Hasegawa
Sadao Manabe
Takeshi Tanimoto
Takashi Miyazaki
Taizou Kamishita
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Toko Yakuhin Kogyo KK
Research Foundation for Microbial Diseases of Osaka University BIKEN
National Institute of Infectious Diseases
Original Assignee
Toko Yakuhin Kogyo KK
Research Foundation for Microbial Diseases of Osaka University BIKEN
National Institute of Infectious Diseases
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/145—Orthomyxoviridae, e.g. influenza virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5254—Virus avirulent or attenuated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A61K2039/541—Mucosal route
    • A61K2039/543—Mucosal route intranasal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55555—Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55561—CpG containing adjuvants; Oligonucleotide containing adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/58—Medicinal preparations containing antigens or antibodies raising an immune response against a target which is not the antigen used for immunisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6093—Synthetic polymers, e.g. polyethyleneglycol [PEG], Polymers or copolymers of (D) glutamate and (D) lysine
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16111—Influenzavirus A, i.e. influenza A virus
    • C12N2760/16134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pulmonology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Molecular Biology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

Composición de vacuna para administración a través de la mucosa nasal, que comprende (i) un antígeno del virus de la gripe, (ii) ácido polirriboinosínico polirribocitidílico (poli (I:C)), poli (I:CxU) o poli (IxU:C), y (iii) un polímero de carboxivinilo, en la que x es, de promedio, un número de 3 a 40.

Description

imagen1
imagen2
imagen3
imagen4
imagen5
imagen6
imagen7
[Tabla 4] Vacuna de HA A/Hiroshima experimental + poli (I:C) o Ampligen de HI en suero
grupo
1 2 3 4 5 6 7 8 9 10
antígeno
vacuna Ha A/Hiroshima /52/2005 virión completo ninguno (control)
vía de administración
in sc in
dosis
2 µl en cada fosa nasal (cavidad nasal) 2,7 µl en cada fosa nasal (cavidad nasal) 2 µl en cada fosa nasal (cavidad nasal) 100 µl 2 µl en cada fosa nasal (cavidad nasal)
números/grupo
5 10
antígeno (µg de HA o ptn)
0,1 0,1 0,1 0,1 0,1 0,1 0,1 0,1 0,2
Poli (I:C)
0,1 1 10
Ampligen (nuevo)
0,1 1 10
No. de animal
1 5 5 5 40 5 5 5 160 5 5
2
5 5 5 5 5 5 5 320 5 5
3
5 5 5 40 5 5 5 320 5 5
4
5 5 5 20 5 10 5 160 5 5
5
5
5
5
5
5
10 5 80
5
5
media geométrica
5,0 5,0 5,0 15,2 5,0 6,6 5,0 183,8 5,0 5,0
SD
0,0 0,0 0,0 17,5 0,0 2,7 0,0 107,3 0,0 0,0
media geométrica del título (GMT, 2^n)
2,3 2,3 2,3 3,9 2,3 2,7 2,3 7,5 2,3 2,3
tasa de seroconversión (≥40%)
0,0 0,0 0,0 40,0 0,0 0,0 0,0 100,00 0,0 0,0
5
[Tabla 5]
10
Prueba preliminar del efecto farmacológico del Ampligen: virión completo de H5 de Indonesia (25/09/2008) constitución del grupo de prueba
grupo
antígeno (µg/dosis) Ampligen (µg/dosis) CVP (%) n vía de administración dosis (µl) nota
1
0,3 3,00 5 in 2,0 antígeno: Ampligen = 1:10
2
0,1 1,00 5 in 2,0
3
0,033 0,33 5 in 2,0
4
0,3 3,00 0,55 5 in 2,0 antígeno: Ampligen = 1:10 + CVP
5
0,1 1,00 0,55 5 in 2,0
6
0,033 0,33 0,55 5 in 2,0
7
0,3 6,00 5 in 2,0 antígeno: Ampligen = 1:10
8
0,1 2,00 5 in 2,0
9
0,033 0,67 5 in 2,0
10
0,3 0,55 5 in 2,0 antígeno + CVP
11
0,1 0,55 5 in 2,0
12
0,033 0,55 5 in 2,0
13
0,3 5 in 2,0 antígeno solo
14
0,1 5 in 2,0
15
0,033 5 in 2,0
16
0,3 5 in 50,0 antígeno solo, control intramuscular
17
10 in 2,0 control de solución salina
9
imagen8
imagen9
[Tabla 7]
Prueba preliminar del efecto farmacológico del Ampligen: virión completo de H5 de Indonesia (25/09/2008) NT en suero (19/11/2008)
grupo
4 5 6 13 16
antígeno (µg/dosis)
0,3 0,1 0,033 0,3 0,3
Ampligen (µg/dosis)
3,00 1,00 0,33
CVP (%)
0,55 0,55 0,55
Poli L-Arg (µg/dosis)
vía de administración
in in in in im
No. de animal
1 80 160 80 20 160
2
1.280 10 40 10 80
3
80 160 40 10 320
4
160 160 160 10 80
5
160 160 40 10 640
media geométrica del título (GMT)
183,8 91,9 60,6 11,5 183,8
título promedio (2^n)
7,5 6,5 5,9 3,5 7,5
10
15
20
25
30
35
40
45
50
12
imagen10
imagen11
imagen12
imagen13
imagen14
imagen15
imagen16
5
10
15
20
25
30
35
40
45
50
55
60
65
imagen17
imagen18
imagen19

[Tabla 15] Prueba de HI en suero (23/07/2009) reactividad cruzada (A/VN)
grupo
4 5 7 8 26 27
cantidad de antígeno administrado (µg de HA/dosis)
0,3 0,1 0,3 0,1 0,3 0,3
frecuencia de administración
3 2 3 2
vía de administración
transnasal transnasal transnasal transnasal intramuscular intramuscular
adición de adyuvante (Ampligen), CVP
sí sí sí sí ninguno ninguno
No. de animal
1 5 20 5 5 5 5
2
5 5 5 5 5 5
3
5 5 5 5 20 5
4
5 5 5 5 10 5
5
5
10
5
5
5
5
6
5 5 5 5 5 5
7
5 20 5 5 5 5
8
5 20 5 5 5 5
9
5 5 5 10 5 5
10
5 imagen20 imagen21 imagen22 5 5
título promedio de anticuerpo (GMT)
5,0 8,6 5,0 5,4 6,2 5,0
varianza
0,0 7,3 0,0 1,7 4,8 0,0
tasa de seroconversión (título de anticuerpos no inferior al 40%)
0,0 0,0 0,0 0,0 0,0 0,0
10
15
20
25
30
23
imagen23
imagen24
imagen25
imagen26
imagen27
imagen28
imagen29
imagen30
imagen31
imagen32
imagen33

Claims (1)

  1. imagen1
ES10714104.6T 2009-03-31 2010-03-31 Procedimiento para la prevención de la gripe utilizando una vacuna para administración intranasal Active ES2588183T3 (es)

Applications Claiming Priority (3)

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US16509809P 2009-03-31 2009-03-31
US165098P 2009-03-31
PCT/JP2010/056274 WO2010114169A1 (en) 2009-03-31 2010-03-31 Method for prophylaxis of influenza using vaccine for intranasal administration

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ES2588183T3 true ES2588183T3 (es) 2016-10-31

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US (1) US9603919B2 (es)
EP (1) EP2413961B1 (es)
JP (2) JP5762307B2 (es)
AU (1) AU2010232180B2 (es)
ES (1) ES2588183T3 (es)
WO (1) WO2010114169A1 (es)

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US20120082697A1 (en) 2012-04-05
JP2012521965A (ja) 2012-09-20
US9603919B2 (en) 2017-03-28
JP5762307B2 (ja) 2015-08-12
WO2010114169A1 (en) 2010-10-07
JP5921634B2 (ja) 2016-05-24
HK1166704A1 (zh) 2012-11-09
AU2010232180B2 (en) 2016-09-22
JP2015028070A (ja) 2015-02-12
EP2413961B1 (en) 2016-08-17
EP2413961A1 (en) 2012-02-08
AU2010232180A1 (en) 2011-11-03

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