Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133146
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2005-08-22
Brief Title:
Assessment of the Contribution of Monophosphoryl Lipid A MPL to a Grass Pollen Allergy Vaccine
Sponsor:
Allergy Therapeutics
Organization:
Allergy Therapeutics
Study Overview
Official Title:
Double-Blind Phase 2a Study to Demonstrate the Contribution of MPL to Tyrosine Adsorbed GrassRye Pollen Allergoid With a Single-Blind Portion to Evaluate Residual Allergenicity in Skin Test in Volunteers Allergic to Grass Rye Pollen
Status:
COMPLETED
Status Verified Date:
2021-07
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 GrassMATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to grass and rye pollen hay fever
The tolerability and immunogenicity of GrassMATA allergen modified with glutaraldehyde and adsorbed to tyrosine with and without MPL adjuvant monophosphoryl lipid A extracted from a bacterial cell surface was investigated in this double-blind randomized Phase IIa study in volunteers allergic to grass and rye pollen
Additionally this study assessed residual allergenicity of the modified grass and rye pollen in the product GrassMATAMPL using skin prick testing in volunteers allergic to grass and rye pollen
The tolerability and immunogenicity of GrassMATA allergen modified with glutaraldehyde and adsorbed to tyrosine with and without MPL adjuvant monophosphoryl lipid A extracted from a bacterial cell surface was investigated in this double-blind randomized Phase IIa study in volunteers allergic to grass and rye pollen
Additionally this study assessed residual allergenicity of the modified grass and rye pollen in the product GrassMATAMPL using skin prick testing in volunteers allergic to grass and rye pollen
Detailed Description:
Double-blind Phase IIa study with a single-blind component to evaluate skin tests allergenicity and to demonstrate the contribution of MPL to tyrosine adsorbed grassrye pollen allergoid Grass MATA in volunteers allergic to grass and rye pollen Volunteers underwent skin prick tests with 12 different solutions and then were randomized to receive 3 subcutaneous injections of either Grass MATA MPL or Grass MATA over approximately 14-day intervals for total study duration of approximately 67 days
Enrollment was planned for 40 patients 20 in each active treatment group Data from 41 patients who completed the single blind portion of the study and from 40 randomized patients who took part in the double blind portion of the study were analyzed and included in the study Screening was performed at Visit 0 then subjects fulfilling all inclusionexclusion criteria underwent a series of skin prick tests to evaluate the tolerability of native allergen modified allergen and tyrosine adsorbates with and without MPL Visit 1 single-blind portion of the study
At Visit 2 subjects were randomized 11 to receive either Grass MATA MPL or Grass MATA and received the first injection of treatment The dosing regimen consisted of three 05 mL subcutaneous injections of increasing strengths and was the same for both treatment groups Patients were asked to remain in the clinic for an observation period of 30 to 45 minutes following study drug administration in order to record adverse reactions associated The second and third injections of treatment were administered at Visit 4 and Visit 6 Each dosing visit occurred at least 14 days after the previous one
Safety follow-up were performed 7-8 days after each dosing at Visit 3 5 and 7
Subjects terminated the study after completion of Visit 8 Post-treatment visit
To assess the immunological response to Grass MATA MPL versus Grass MATA blood test were performed at baseline Visit 0 after the first administration Visit 3 and at the end of the study Visit 8 Safety and tolerability of the different allergens used during prick test and of Grass MATA MPL versus Grass MATA were also be evaluated
Enrollment was planned for 40 patients 20 in each active treatment group Data from 41 patients who completed the single blind portion of the study and from 40 randomized patients who took part in the double blind portion of the study were analyzed and included in the study Screening was performed at Visit 0 then subjects fulfilling all inclusionexclusion criteria underwent a series of skin prick tests to evaluate the tolerability of native allergen modified allergen and tyrosine adsorbates with and without MPL Visit 1 single-blind portion of the study
At Visit 2 subjects were randomized 11 to receive either Grass MATA MPL or Grass MATA and received the first injection of treatment The dosing regimen consisted of three 05 mL subcutaneous injections of increasing strengths and was the same for both treatment groups Patients were asked to remain in the clinic for an observation period of 30 to 45 minutes following study drug administration in order to record adverse reactions associated The second and third injections of treatment were administered at Visit 4 and Visit 6 Each dosing visit occurred at least 14 days after the previous one
Safety follow-up were performed 7-8 days after each dosing at Visit 3 5 and 7
Subjects terminated the study after completion of Visit 8 Post-treatment visit
To assess the immunological response to Grass MATA MPL versus Grass MATA blood test were performed at baseline Visit 0 after the first administration Visit 3 and at the end of the study Visit 8 Safety and tolerability of the different allergens used during prick test and of Grass MATA MPL versus Grass MATA were also be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| P2DP05004 | OTHER | Protocol number | None |