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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000820-27 | EudraCT Number |
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The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against mite allergy
Double blind placebo-controlled study. The subjects will receive medication during 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MM09 Mannosylated 5.000 subcutaneous | Experimental | 5.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo. |
|
| MM09 Mannosylated 10.000 subcutaneous | Experimental | 10.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo. |
|
| MM09 Mannosylated 30.000 subcutaneous | Experimental | 30.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo. |
|
| MM09 Mannosylated 50.000 subcutaneous | Experimental | 50.000 MTU/ml of subcutaneous immunotherapy and sublingual placebo. |
|
| MM09 Mannosylated 5.000 sublingual | Experimental | 5.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MM09 Mannosylated 5.000 subcutaneous | Biological | Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration required to elicit a positive response after nasal provocation test (NPT) | Change in the threshold concentration of mite allergen extract, measured in Histamine Equivalent Prick per ml (HEP/ml), needed to trigger a positive response after nasal provocation test (NPT) assessed by acoustic rhinometry. This will be compared between the beginning and end of the trial and among active groups and placebo. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dose finding skin prick test | Comparison between the beginning and end of the trial and among active groups and placebo | 4 months |
| Number of participants with treatment-related adverse events as assessed by MM09-SIT-013 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mª Dolores Hernández, PhD; MD | Principal Investigator | |
| Pilar Alba, PhD; MD | Principal Investigator | |
| Carmen Pérez, PhD; MD | Principal Investigator | |
| Javier Montoro, PhD; MD | Principal Investigator | |
| Antonio de Mateo, PhD; MD | Principal Investigator | |
| David El-Qutob, PhD; MD | Principal Investigator | |
| Javier Fernández, PhD; MD | Principal Investigator | |
| Vicente Jover, PhD; MD | Principal Investigator | |
| Isabel Flores, PhD; MD | Principal Investigator | |
| Mónica Antón, PhD; MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Elche | Elche | Alicante | 03203 | Spain | ||
| Hospital Del Vinalopo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29319882 | Background | Soria I, Lopez-Relano J, Vinuela M, Tudela JI, Angelina A, Benito-Villalvilla C, Diez-Rivero CM, Cases B, Manzano AI, Fernandez-Caldas E, Casanovas M, Palomares O, Subiza JL. Oral myeloid cells uptake allergoids coupled to mannan driving Th1/Treg responses upon sublingual delivery in mice. Allergy. 2018 Apr;73(4):875-884. doi: 10.1111/all.13396. Epub 2018 Jan 31. | |
| 26603537 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 28, 2022 | |
| Reset | Aug 23, 2022 |
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| MM09 Mannosylated 10.000 sublingual | Experimental | 10.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo. |
|
| MM09 Mannosylated 30.000 sublingual | Experimental | 30.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo. |
|
| MM09 Mannosylated 50.000 sublingual | Experimental | 50.000 MTU/ml of sublingual immunotherapy and subcutaneous placebo. |
|
| Placebo Sublingual Placebo subcutaneous | Placebo Comparator | Sublingual and subcutaneous placebo. |
|
|
| MM09 Mannosylated 10.000 subcutaneous | Biological | Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous |
|
| MM09 Mannosylated 30.000 subcutaneous | Biological | Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous |
|
| MM09 Mannosylated 50.000 subcutaneous | Biological | Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous |
|
| MM09 Mannosylated 5.000 sublingual | Biological | Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml sublingual |
|
| MM09 Mannosylated 10.000 sublingual | Biological | Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml sublingual |
|
| MM09 Mannosylated 30.000 sublingual | Biological | Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml sublingual |
|
| MM09 Mannosylated 50.000 sublingual | Biological | Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 MTU (Mannosylated Therapeutic Units)/ml sublingual |
|
| Subcutaneous placebo | Biological | Comparison between placebo and active group |
|
| Sublingual placebo | Biological | Comparison between placebo and active group |
|
Comparison between the beginning and end of the trial and among active groups and placebo
| 4 months |
| Carmen Andreu, PhD; MD | Principal Investigator |
| Luis Angel Navarro, PhD; MD | Principal Investigator |
| Ángel Ferrer | Principal Investigator |
| Antonio Nieto, PhD; MD | Study Director |
| Elche |
| Alicante |
| 03293 |
| Spain |
| Hospital General Universitario de Elda-Virgen de La Salud | Elda | Alicante | 03600 | Spain |
| Hospital Vega Baja Orihuela | Orihuela | Alicante | 03314 | Spain |
| Hospital Universitari de Castelló | Castellon | Castellón | 12004 | Spain |
| Hospital de La Plana | Vila-real | Castellón | 12540 | Spain |
| Hospital de Manises | Manises | Valencia | 46940 | Spain |
| Hospital Lluis Alcanyis de Xátiva | Xátiva | Valencia | 46800 | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital Vithas Internacional Medimar | Alicante | 03016 | Spain |
| Hospital Arnau de Vilanova | Valencia | 46015 | Spain |
| Hospital Universitario Doctor Peset | Valencia | 46017 | Spain |
| HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE Adults | Valencia | 46026 | Spain |
| HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE child | Valencia | 46026 | Spain |
| Manzano AI, Javier Canada F, Cases B, Sirvent S, Soria I, Palomares O, Fernandez-Caldas E, Casanovas M, Jimenez-Barbero J, Subiza JL. Structural studies of novel glycoconjugates from polymerized allergens (allergoids) and mannans as allergy vaccines. Glycoconj J. 2016 Feb;33(1):93-101. doi: 10.1007/s10719-015-9640-4. Epub 2015 Nov 25. |
| 27177779 | Background | Sirvent S, Soria I, Cirauqui C, Cases B, Manzano AI, Diez-Rivero CM, Reche PA, Lopez-Relano J, Martinez-Naves E, Canada FJ, Jimenez-Barbero J, Subiza J, Casanovas M, Fernandez-Caldas E, Subiza JL, Palomares O. Novel vaccines targeting dendritic cells by coupling allergoids to nonoxidized mannan enhance allergen uptake and induce functional regulatory T cells through programmed death ligand 1. J Allergy Clin Immunol. 2016 Aug;138(2):558-567.e11. doi: 10.1016/j.jaci.2016.02.029. Epub 2016 Apr 13. |
| 28778325 | Background | Soria I, Alvarez J, Manzano AI, Lopez-Relano J, Cases B, Mas-Fontao A, Canada FJ, Fernandez-Caldas E, Casanovas M, Jimenez-Barbero J, Palomares O, Vinals-Florez LM, Subiza JL. Mite allergoids coupled to nonoxidized mannan from Saccharomyces cerevisae efficiently target canine dendritic cells for novel allergy immunotherapy in veterinary medicine. Vet Immunol Immunopathol. 2017 Aug;190:65-72. doi: 10.1016/j.vetimm.2017.07.004. Epub 2017 Jul 23. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 28, 2022 | Aug 23, 2022 |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007154 | Immune System Diseases |
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