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Reactogenicity and safety assessment of an attenuated nanovaccine against scorpion envenomation: Preclinical study

•Nps – V∗ was highly immunogenic in animal models (rabbit and mouse).•Nps – V∗ did not change activities on serum peroxidases and cytokine levels.•This nanovaccine is safe and no systemic side-effects were observed.•The repeated administration produces a transient edema/erythema in injection site.•N... Full description

Journal Title: Vaccine 2017, Vol.35 (48), p.6657-6663
Main Author: Nait Mohamed, Faez Amokrane
Other Authors: Nouri, Abdelmounaim , Laraba-Djebari, Fatima
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: Netherlands: Elsevier Ltd
ID: ISSN: 0264-410X
Link: https://www.ncbi.nlm.nih.gov/pubmed/29061347
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title: Reactogenicity and safety assessment of an attenuated nanovaccine against scorpion envenomation: Preclinical study
format: Article
creator:
  • Nait Mohamed, Faez Amokrane
  • Nouri, Abdelmounaim
  • Laraba-Djebari, Fatima
subjects:
  • Alginates - administration & dosage
  • Alginates - adverse effects
  • Alginates - chemistry
  • Alginic acid
  • Aluminum
  • Analysis
  • Androctonus australis hector venom
  • Animals
  • Antigens
  • Bites and stings
  • Breeding of animals
  • Calcium
  • Calcium alginate
  • Calcium-alginate nanoparticles
  • Cytokines - biosynthesis
  • Cytokines - immunology
  • Drug dosages
  • Drug Evaluation, Preclinical
  • Edema
  • Erythema
  • Food consumption
  • Glucuronic Acid - administration & dosage
  • Glucuronic Acid - adverse effects
  • Glucuronic Acid - chemistry
  • Hexuronic Acids - administration & dosage
  • Hexuronic Acids - adverse effects
  • Hexuronic Acids - chemistry
  • Humans
  • Immunotherapy
  • Inflammation
  • Inflammatory response
  • Injection
  • Medical research
  • Medicine, Experimental
  • Mice
  • Muridae
  • Nanoparticles
  • Nanoparticles - administration & dosage
  • Nanoparticles - adverse effects
  • Nanoparticles - chemistry
  • Nanoparticles - therapeutic use
  • Nanotechnology - methods
  • Nanovaccine
  • Potassium
  • Rabbits
  • Reactogenicity
  • Safety
  • Safety and security measures
  • Scorpion Venoms - administration & dosage
  • Scorpion Venoms - adverse effects
  • Scorpion Venoms - radiation effects
  • Scorpion Venoms - therapeutic use
  • Skin
  • Studies
  • Tissue analysis
  • Toxicity
  • Vaccination
  • Vaccination - methods
  • Vaccines
  • Venom
ispartof: Vaccine, 2017, Vol.35 (48), p.6657-6663
description: •Nps – V∗ was highly immunogenic in animal models (rabbit and mouse).•Nps – V∗ did not change activities on serum peroxidases and cytokine levels.•This nanovaccine is safe and no systemic side-effects were observed.•The repeated administration produces a transient edema/erythema in injection site.•Nps – V∗ can be tested in superior animals, then in a phase 1 clinical studies. An attenuated nanovaccine (Nps – V∗) has been developed to protect humans from fatal scorpion envenomation in at-risk regions. This study was conducted to evaluate the toxicity and the local reactogenicity of the Nps – V∗ nanovaccine developed against Androctonus australis hector (Aah) venom. Assessment of the systemic inflammatory response and serum cytokine levels were evaluated in vaccinated mice with 100μg of irradiated Aah venom (V∗) encapsulated or not into polymeric calcium-alginate nanoparticles (Nps) and injected by subcutaneous (s.c) route. The local reactogenicity was evaluated by dermal Draize observations and skin tissue analysis at the injection site of vaccinated rabbits with 250 or 500μg of V∗-loaded into Nps. All animals gained weight and had normal food consumption during the study. Additionally, results showed that the nanoformulation Nps – V∗ did not cause clinical evidence of systemic toxicity in mice or rabbits, a transient edema/erythema at the injection site was only recorded as treatment-related reactogenicity. These results indicated a favorable safety profile for Nps – V∗ and supported its use in superior animal tests, then in a Phase 1 clinical trial.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0264-410X
fulltext: fulltext
issn:
  • 0264-410X
  • 1873-2518
url: Link


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titleReactogenicity and safety assessment of an attenuated nanovaccine against scorpion envenomation: Preclinical study
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description•Nps – V∗ was highly immunogenic in animal models (rabbit and mouse).•Nps – V∗ did not change activities on serum peroxidases and cytokine levels.•This nanovaccine is safe and no systemic side-effects were observed.•The repeated administration produces a transient edema/erythema in injection site.•Nps – V∗ can be tested in superior animals, then in a phase 1 clinical studies. An attenuated nanovaccine (Nps – V∗) has been developed to protect humans from fatal scorpion envenomation in at-risk regions. This study was conducted to evaluate the toxicity and the local reactogenicity of the Nps – V∗ nanovaccine developed against Androctonus australis hector (Aah) venom. Assessment of the systemic inflammatory response and serum cytokine levels were evaluated in vaccinated mice with 100μg of irradiated Aah venom (V∗) encapsulated or not into polymeric calcium-alginate nanoparticles (Nps) and injected by subcutaneous (s.c) route. The local reactogenicity was evaluated by dermal Draize observations and skin tissue analysis at the injection site of vaccinated rabbits with 250 or 500μg of V∗-loaded into Nps. All animals gained weight and had normal food consumption during the study. Additionally, results showed that the nanoformulation Nps – V∗ did not cause clinical evidence of systemic toxicity in mice or rabbits, a transient edema/erythema at the injection site was only recorded as treatment-related reactogenicity. These results indicated a favorable safety profile for Nps – V∗ and supported its use in superior animal tests, then in a Phase 1 clinical trial.
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1EISSN: 1873-2518
2DOI: 10.1016/j.vaccine.2017.10.028
3PMID: 29061347
languageeng
publisherNetherlands: Elsevier Ltd
subjectAlginates - administration & dosage ; Alginates - adverse effects ; Alginates - chemistry ; Alginic acid ; Aluminum ; Analysis ; Androctonus australis hector venom ; Animals ; Antigens ; Bites and stings ; Breeding of animals ; Calcium ; Calcium alginate ; Calcium-alginate nanoparticles ; Cytokines - biosynthesis ; Cytokines - immunology ; Drug dosages ; Drug Evaluation, Preclinical ; Edema ; Erythema ; Food consumption ; Glucuronic Acid - administration & dosage ; Glucuronic Acid - adverse effects ; Glucuronic Acid - chemistry ; Hexuronic Acids - administration & dosage ; Hexuronic Acids - adverse effects ; Hexuronic Acids - chemistry ; Humans ; Immunotherapy ; Inflammation ; Inflammatory response ; Injection ; Medical research ; Medicine, Experimental ; Mice ; Muridae ; Nanoparticles ; Nanoparticles - administration & dosage ; Nanoparticles - adverse effects ; Nanoparticles - chemistry ; Nanoparticles - therapeutic use ; Nanotechnology - methods ; Nanovaccine ; Potassium ; Rabbits ; Reactogenicity ; Safety ; Safety and security measures ; Scorpion Venoms - administration & dosage ; Scorpion Venoms - adverse effects ; Scorpion Venoms - radiation effects ; Scorpion Venoms - therapeutic use ; Skin ; Studies ; Tissue analysis ; Toxicity ; Vaccination ; Vaccination - methods ; Vaccines ; Venom
ispartofVaccine, 2017, Vol.35 (48), p.6657-6663
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02017 Elsevier Ltd
1Copyright © 2017 Elsevier Ltd. All rights reserved.
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description•Nps – V∗ was highly immunogenic in animal models (rabbit and mouse).•Nps – V∗ did not change activities on serum peroxidases and cytokine levels.•This nanovaccine is safe and no systemic side-effects were observed.•The repeated administration produces a transient edema/erythema in injection site.•Nps – V∗ can be tested in superior animals, then in a phase 1 clinical studies. An attenuated nanovaccine (Nps – V∗) has been developed to protect humans from fatal scorpion envenomation in at-risk regions. This study was conducted to evaluate the toxicity and the local reactogenicity of the Nps – V∗ nanovaccine developed against Androctonus australis hector (Aah) venom. Assessment of the systemic inflammatory response and serum cytokine levels were evaluated in vaccinated mice with 100μg of irradiated Aah venom (V∗) encapsulated or not into polymeric calcium-alginate nanoparticles (Nps) and injected by subcutaneous (s.c) route. The local reactogenicity was evaluated by dermal Draize observations and skin tissue analysis at the injection site of vaccinated rabbits with 250 or 500μg of V∗-loaded into Nps. All animals gained weight and had normal food consumption during the study. Additionally, results showed that the nanoformulation Nps – V∗ did not cause clinical evidence of systemic toxicity in mice or rabbits, a transient edema/erythema at the injection site was only recorded as treatment-related reactogenicity. These results indicated a favorable safety profile for Nps – V∗ and supported its use in superior animal tests, then in a Phase 1 clinical trial.
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3Alginic acid
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11Calcium
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14Cytokines - biosynthesis
15Cytokines - immunology
16Drug dosages
17Drug Evaluation, Preclinical
18Edema
19Erythema
20Food consumption
21Glucuronic Acid - administration & dosage
22Glucuronic Acid - adverse effects
23Glucuronic Acid - chemistry
24Hexuronic Acids - administration & dosage
25Hexuronic Acids - adverse effects
26Hexuronic Acids - chemistry
27Humans
28Immunotherapy
29Inflammation
30Inflammatory response
31Injection
32Medical research
33Medicine, Experimental
34Mice
35Muridae
36Nanoparticles
37Nanoparticles - administration & dosage
38Nanoparticles - adverse effects
39Nanoparticles - chemistry
40Nanoparticles - therapeutic use
41Nanotechnology - methods
42Nanovaccine
43Potassium
44Rabbits
45Reactogenicity
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50Scorpion Venoms - radiation effects
51Scorpion Venoms - therapeutic use
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53Studies
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55Toxicity
56Vaccination
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19Erythema
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22Glucuronic Acid - adverse effects
23Glucuronic Acid - chemistry
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38Nanoparticles - adverse effects
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49Scorpion Venoms - adverse effects
50Scorpion Venoms - radiation effects
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issn0264-410X
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abstract•Nps – V∗ was highly immunogenic in animal models (rabbit and mouse).•Nps – V∗ did not change activities on serum peroxidases and cytokine levels.•This nanovaccine is safe and no systemic side-effects were observed.•The repeated administration produces a transient edema/erythema in injection site.•Nps – V∗ can be tested in superior animals, then in a phase 1 clinical studies. An attenuated nanovaccine (Nps – V∗) has been developed to protect humans from fatal scorpion envenomation in at-risk regions. This study was conducted to evaluate the toxicity and the local reactogenicity of the Nps – V∗ nanovaccine developed against Androctonus australis hector (Aah) venom. Assessment of the systemic inflammatory response and serum cytokine levels were evaluated in vaccinated mice with 100μg of irradiated Aah venom (V∗) encapsulated or not into polymeric calcium-alginate nanoparticles (Nps) and injected by subcutaneous (s.c) route. The local reactogenicity was evaluated by dermal Draize observations and skin tissue analysis at the injection site of vaccinated rabbits with 250 or 500μg of V∗-loaded into Nps. All animals gained weight and had normal food consumption during the study. Additionally, results showed that the nanoformulation Nps – V∗ did not cause clinical evidence of systemic toxicity in mice or rabbits, a transient edema/erythema at the injection site was only recorded as treatment-related reactogenicity. These results indicated a favorable safety profile for Nps – V∗ and supported its use in superior animal tests, then in a Phase 1 clinical trial.
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pubElsevier Ltd
pmid29061347
doi10.1016/j.vaccine.2017.10.028