Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118625
Status:
COMPLETED
Last Update Posted:
2010-06-17
First Post:
2005-07-01
Brief Title:
Assessment of the Contribution of Monophosphoryl Lipid A MPL to a Tree Pollen Allergy Vaccine
Sponsor:
Allergy Therapeutics
Organization:
Allergy Therapeutics
Study Overview
Official Title:
A Double-Blind Phase IIa Study to Demonstrate the Contribution of MPL to Tyrosine Adsorbed Birch Hazel Alder Pollen Allergoid Tree MATA With a Single-Blind Portion to Evaluate the Residual Allergenicity in Skin Test in Volunteers Allergic to Birch and Hazel and Alder Pollen
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Allergen-specific immunotherapy SIT the administration of gradually increasing quantities of an allergen extract to an allergic patient is a curative approach which directly treats the underlying allergic disease Tree MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to tree pollen hay fever
The tolerability and immunogenicity of Tree MATA allergen modified with glutaraldehyde and adsorbed to tyrosine with and without MPL adjuvant monophosphoryl lipid A extracted from a bacterial cell surface is being investigated in this double-blind randomized Phase IIa study in volunteers allergic to birch and hazel and alder pollen
Additionally this study will assess residual allergenicity of the modified birch and hazel and alder pollen in the product Tree MATA MPL using skin prick testing in volunteers allergic to birch and hazel and alder pollen
The tolerability and immunogenicity of Tree MATA allergen modified with glutaraldehyde and adsorbed to tyrosine with and without MPL adjuvant monophosphoryl lipid A extracted from a bacterial cell surface is being investigated in this double-blind randomized Phase IIa study in volunteers allergic to birch and hazel and alder pollen
Additionally this study will assess residual allergenicity of the modified birch and hazel and alder pollen in the product Tree MATA MPL using skin prick testing in volunteers allergic to birch and hazel and alder pollen
Detailed Description:
Allergic rhinitis is a nasal inflammatory disorder initiated by an immunoglobulin-E IgE mediated hypersensitivity to allergens When a patient is exposed to an allergen to which he or she is sensitive the allergen cross-links with the IgE antibody which is bound to the surface of tissue mast cells This cross-linking then triggers the release of proinflammatory substances such as histamine and eicosanoids and is known as the early response In a skin prick test this reaction produces a wheal-and-flare response Normally systemic exposure to an allergen also leads to the more prolonged late reaction in which eosinophils basophils and activated T cells are recruited to the site of exposure The recruited T cells also secrete inflammatory cytokines such as interleukin-4 IL-4 and IL-5 typically associated with helper T cells type 2 TH2 which further propagate the inflammatory cascade Typically the early response occurs within 15 to 30 minutes but as quickly as a few seconds and usually resolves within 1 to 3 hours and the late response occurs within 6 to 12 hours and resolves in 24 hours
Allergic vaccination AV also referred to as immunotherapy or allergen-specific immunotherapy SIT is a curative approach that is available for allergic diseases which directly treats the underlying disease AV is the practice of administering gradually increasing quantities of an allergen extract to an allergic patient to ameliorate the symptoms associated with the subsequent exposure to the causative allergen AV is believed to exert its beneficial effects on the immune system at least in part by modifying the T-lymphocyte response to subsequent natural allergen exposure AV has been shown to inhibit both early and late responses to allergen exposure AV acts on T cells to modify peripheral and mucosal TH2 responses to an allergen in favor of helper T cell type 1 TH1 responses One of the hallmarks of successful AV is the redressing of a healthy TH1TH2-balance
Although efficacious immunotherapy is generally considered a long-term disease modifying measure that requires months to years of treatment entails multiple injection regimens and involves some risk for adverse immune reactions
Allergy Therapeutics AT has developed formulations over the years to increase both the safety and efficacy of such treatment In particular the allergen extract has been chemically modified with glutaraldehyde and formulated with L-tyrosine to act as a depot adjuvant and provide a slow release of the allergens or modified allergens This increases the safety profile and enhances the efficacy-associated immunological changes Efficacy could be further improved by adding the immunological adjuvant monophosphoryl lipid A MPL
Tree MATA MPL is designed to provide a vaccine that will be efficacious with only three escalating dose injections in contrast to the longer schedules currently in use It is designed to have all of the current advantages of an allergy vaccine which can modify the underlying disease process as opposed to pharmacological control which treats only the symptoms The vaccine will also be safer to use than a formulation containing a similar mass of unmodified allergen extract due to the propensity of the unmodified allergen extract to cause severe local allergic reactions or anaphylaxis because of its reduced reactivity with IgE antibody
The tolerability and immunogenicity of Tree MATA with and without MPL adjuvant is being investigated in this double-blind randomized Phase IIa study in volunteers allergic to birch and hazel and alder pollen
Additionally this study will assess residual allergenicity of the modified birch and hazel and alder pollen in the product Tree MATA MPL using skin prick testing in volunteers allergic to birch and hazel and alder pollen
Allergic vaccination AV also referred to as immunotherapy or allergen-specific immunotherapy SIT is a curative approach that is available for allergic diseases which directly treats the underlying disease AV is the practice of administering gradually increasing quantities of an allergen extract to an allergic patient to ameliorate the symptoms associated with the subsequent exposure to the causative allergen AV is believed to exert its beneficial effects on the immune system at least in part by modifying the T-lymphocyte response to subsequent natural allergen exposure AV has been shown to inhibit both early and late responses to allergen exposure AV acts on T cells to modify peripheral and mucosal TH2 responses to an allergen in favor of helper T cell type 1 TH1 responses One of the hallmarks of successful AV is the redressing of a healthy TH1TH2-balance
Although efficacious immunotherapy is generally considered a long-term disease modifying measure that requires months to years of treatment entails multiple injection regimens and involves some risk for adverse immune reactions
Allergy Therapeutics AT has developed formulations over the years to increase both the safety and efficacy of such treatment In particular the allergen extract has been chemically modified with glutaraldehyde and formulated with L-tyrosine to act as a depot adjuvant and provide a slow release of the allergens or modified allergens This increases the safety profile and enhances the efficacy-associated immunological changes Efficacy could be further improved by adding the immunological adjuvant monophosphoryl lipid A MPL
Tree MATA MPL is designed to provide a vaccine that will be efficacious with only three escalating dose injections in contrast to the longer schedules currently in use It is designed to have all of the current advantages of an allergy vaccine which can modify the underlying disease process as opposed to pharmacological control which treats only the symptoms The vaccine will also be safer to use than a formulation containing a similar mass of unmodified allergen extract due to the propensity of the unmodified allergen extract to cause severe local allergic reactions or anaphylaxis because of its reduced reactivity with IgE antibody
The tolerability and immunogenicity of Tree MATA with and without MPL adjuvant is being investigated in this double-blind randomized Phase IIa study in volunteers allergic to birch and hazel and alder pollen
Additionally this study will assess residual allergenicity of the modified birch and hazel and alder pollen in the product Tree MATA MPL using skin prick testing in volunteers allergic to birch and hazel and alder pollen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P2DP05002 | None | None | None |