Clinical efficacy and safety of a depigmented and glutaraldehyde polymerized therapeutic vaccine of Parietaria judaica

García-Sellés, J.; Pascual, Alejandro; Funes, E; Pagán, JA; López, J. Espín; Negro, JM; Hernández, José Antonio Ruíz

doi:10.1157/13045071

Cited by 18 publications

(10 citation statements)

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“…However, no studies have been conducted using rush or ultra-rush schedules. The safety and efficacy of depigmented and glutaraldehyde polymerized extracts has also been studied using conventional build-up schedules [19,20,21,22, 26]. These extracts have shown efficacy using objective parameters, such as specific bronchial provocation and skin tests, demonstrating improvement after 6 months of treatment [22] or after 4 months when a shorter build-up schedule (cluster) was used [23].…”

Section: Discussionmentioning

confidence: 99%

“…The concentration of the modified allergen extracts, and major allergen content, in the vaccines has been reported previously [19,20,21, 25, 26]. Due to the polymerization process, the concentration of major allergens could not be measured in the final product.…”

Section: Methodsmentioning

confidence: 97%

“…The introduction of a depigmentation step, before the polymerization process removes the adsorbed pigments, enhances the solubility of the allergoids and inactivates the enzymatic activity [18]. These recently developed allergoids have been used in clinical studies of efficacy, safety and tolerability [19,20,21,22,23,24,25,26]. These vaccines maintain or increase IgG recognition, while significantly reducing IgE reactivity, which allows shortening of the build-up phase and the administration of higher doses than those used with non-modified allergens.…”

Section: Introductionmentioning

confidence: 99%

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Safety of an Ultra-Rush Immunotherapy Build-Up Schedule with Therapeutic Vaccines Containing Depigmented and Polymerized Allergen Extracts

Casanovas¹,

Martin²,

Jiménez³

et al. 2006

Int Arch Allergy Immunol

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Background: Four administration schedules of immunotherapy have been reported: conventional, cluster, rush and ultra-rush. Objectives: To evaluate the safety and the clinical advantage of using standardized modified allergen extracts in an ultra-rush protocol without premedication and/or hospitalization. Material and Methods: One thousand and sixty-eight patients with rhinoconjunctivitis and/or asthma sensitized to mites and/or pollen were included in a prospective observational study. Patients received a therapeutic vaccine containing depigmented and glutaraldehyde-modified extracts (mites and/or pollens) adsorbed onto alum prescribed by a specialist. The schedule of administration consisted of injecting 0.2 and 0.3 ml of the vial of maximum concentration during the first day of immunotherapy, separated by a time interval of 30 min. All patients reached the maximum dose (0.5 ml) after 2 injections. Tolerance was assessed by recording all side reactions related to immunotherapy, classified according to the criteria of the EAACI. Results: The total number of injections was 2,136. All patients reached the maximum established dose on the 1st day. No premedication was used. Seven clinically relevant local reactions were recorded. The systemic reactions were 5 grade-1 (2 immediate and 3 delayed) and 3 delayed grade-2 reactions. Conclusions: The therapeutic vaccines containing chemically modified extracts can be administered using an alternative ultra-rush schedule in an immunotherapy unit, reaching the maximum dose on the 1st day with 2 injections, without the need of premedication and/or hospitalization.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 97%

Section: Introductionmentioning

confidence: 99%

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Safety of an Ultra-Rush Immunotherapy Build-Up Schedule with Therapeutic Vaccines Containing Depigmented and Polymerized Allergen Extracts

Casanovas¹,

Martin²,

Jiménez³

et al. 2006

Int Arch Allergy Immunol

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“…Many studies have been reported in the literature to evaluate the safety of glutraldehyde and it has been proven that it is non-carcinogenic and safe [31,32].…”

Section: Discussionmentioning

confidence: 99%

Chitosan Beads as a New Gastroretentive System of Verapamil

2006

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The main objective of this project is to design a new extended release gastroretentive mutiparticulate delivery system for verapamil (VP) by incorporation into hydrogel beads made of chitosan. The beads were formed by dropping solutions of VP and chitosan in a solution of tripolyphosphate using a syringe pump with adjustable constant rate. The formed beads were then further crosslinked using glutraldehyde and the excess glutraldehyde were then washed. The physical properties of the prepared beads such as beads sizes, shapes, friabilities and loading efficiencies were determined. The floating characteristics and the release profiles were also studied. The produced beads from all batches showed a very good spherical geometry with mean diameter in the range of 1.3 -2.0 mm. The drug loading efficiency was around 42% for all batches. The % friabilities were less than 1% indicating that the beads surfaces are highly resistant to attrition. Batches B 3 and B 4 (prepared using medium molecular weight chitosan) showed both the slowest release rate among all the prepared batches and showed good floating characteristics comprising short onset (around 5 minutes) and the long duration of buoyancy (more than 6 hours). All the batches exhibited a kinetic model of combined mechanism of diffusion partially through a swollen matrix and partially through water-filled pores. The preparation of chitosan beads using this technique would provide a simple and commercially viable method of preparation of chitosan beads for controlling the release of some drugs.

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“…These so-called allergoids have been in use for SIT for the last 30 years [8, 9, 10, 11, 12]. They are usually generated by incubating the native extracts in the presence of cross-linking agents like formaldehyde, glutaraldehyde or other substances reacting with ε-amino acids [13], which results in the formation of more or less large protein complexes.…”

Section: Introductionmentioning

confidence: 99%

Characterization of Modified Allergen Extracts by in vitro β-Hexosaminidase Release from Rat Basophils

Gehlhar

Peters

Brockmann

et al. 2005

Int Arch Allergy Immunol

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Background: To date, there is no well-established test available that can be used to measure functional properties of modified allergens (allergoids). Due to the cross-linking process, the IgE-binding capacity of the allergens, normally necessary for their characterization, is lost. The aim of this study was to test whether the rat basophilic leukaemia (RBL) cell assay (β-hexosaminidase release by rat basophils upon allergen stimulation) can be adopted to characterize allergoids and to evaluate the assay for testing allergoids and native allergens as well. Methods: Mice were immunized with native and modified Phleumpratense extracts in the presence of alum. Their sera were used to sensitize RBL-2H3 cells and measure basophil stimulation induced by different allergen extracts in the presence or absence of various additives. Results: Sera containing specific IgE against both extract formulations were obtained. Native as well as modified extracts induced dose-dependent β-hexosaminidase release from RBL cells. Both extracts were used to evaluate the characteristics of the assay, which showed high precision. Storage conditions were chosen to enhance extract degradation, which could be read directly from the altered stimulatory capacity of the extracts. Additives turned out to have diverse effects on the assay, whereas phenol had no measurable effect, alum had an inhibitory effect and glycerol elevated basophil activation. Conclusions: For the first time, a reliable, precise in vitro assay is available that is able to directly measure the properties of modified allergen extracts after their production process. The test is well evaluated and its advantages and limitations are discussed in this report.

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Clinical efficacy and safety of a depigmented and glutaraldehyde polymerized therapeutic vaccine of Parietaria judaica

Cited by 18 publications

References 0 publications

Safety of an Ultra-Rush Immunotherapy Build-Up Schedule with Therapeutic Vaccines Containing Depigmented and Polymerized Allergen Extracts

Safety of an Ultra-Rush Immunotherapy Build-Up Schedule with Therapeutic Vaccines Containing Depigmented and Polymerized Allergen Extracts

Chitosan Beads as a New Gastroretentive System of Verapamil

Characterization of Modified Allergen Extracts by in vitro β-Hexosaminidase Release from Rat Basophils

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