Evidence map›Paper›PMID 35570712›Full record

Trial reportAllergy2022

First-in-human phase 2 trial with mite allergoids coupled to mannan in subcutaneous and sublingual immunotherapy.

Antonio Nieto, Ángel Mazón, María Nieto, Ethel Ibáñez, Dah-Tay Jang, Susana Calaforra, Pilar Alba, Carmen Pérez-Francés, Ruth Llusar, Javier Montoro and 15 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Allergy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05641272 (Prospective, Randomised, DBPC Clinical Trial to Evaluate the Efficacy and Safety of Polymerized and Mannan Conjugated Allergen Extract of Dermatophagoides for the Treatment of Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
3.2field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05641272 phase2 / phase3not yet recruitingnot on this mapstarted 2023, after this paper: background citation

Prospective, Randomised, DBPC Clinical Trial to Evaluate the Efficacy and Safety of Polymerized and Mannan Conjugated Allergen Extract of Dermatophagoides for the Treatment of Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma

TypeinterventionalSponsorInmunotek S.L.Ran2023 to 2026Enrolled90ConditionsAllergic Rhinitis, Allergic Asthma, Allergic Rhinoconjunctivitis, Allergy to House Dust MiteArms3,000 MM09, 9,000 MM09, Placebo sublingual
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 25 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Efficacy and safety of Sublingual immunotherapy for allergic rhinitis: an overview of systematic reviews and meta analyses.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
    Review
  6. Immunotherapy for asthma.Cellular & molecular immunology · 2025
    Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. [Research progress and clinical application of allergen nasal provocation test].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2023
    Review
  14. Review
  15. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 11 institutions in 1 country.

Antonio NietoUnit of Pediatric Allergy and Pneumology, Hospital Universitari i Politècnic la Fe, Valencia, Spain.ORCID 0000-0002-6302-6115
Ángel MazónUnit of Pediatric Allergy and Pneumology, Hospital Universitari i Politècnic la Fe, Valencia, Spain.ORCID 0000-0001-5639-1037
María NietoUnit of Pediatric Allergy and Pneumology, Hospital Universitari i Politècnic la Fe, Valencia, Spain.
Ethel IbáñezDepartment of Allergy, Hospital Universitari i Politècnic la Fe, Valencia, Spain.ORCID 0000-0002-4205-7262
Dah-Tay JangUnit of Pediatric Allergy and Pneumology, Hospital Universitari i Politècnic la Fe, Valencia, Spain.ORCID 0000-0002-3791-4389
Susana CalaforraAllergy Service, Hospital Manises, Valencia, Spain.
Pilar AlbaAllergy Service, Hospital Manises, Valencia, Spain.
Carmen Pérez-FrancésAllergy Service, University Hospital Doctor Peset, Valencia, Spain.
Ruth LlusarAllergy Service, University Hospital Doctor Peset, Valencia, Spain.
Javier MontoroAllergy Service, University Hospital Arnau de Vilanova, Valencia, Spain.
Antonio de MateoAllergy Service, University Hospital, Castellón, Spain.
Remedios AlamarAllergy Service, University Hospital, Castellón, Spain.
David El-QutobAllergy Service, University Hospital de la Plana, Castellón, Spain.ORCID 0000-0003-4837-782X
Javier FernándezAllergy Service, Hospital General Universitario Dr. Balmis, ISABIAL, Alicante, Spain.ORCID 0000-0003-1065-7199
Luis MoralPediatric Allergy and Respiratory Unit, Hospital Universitario Dr. Balmis, ISABIAL, Alicante, Spain.ORCID 0000-0002-7066-6073
Teresa ToralPediatric Allergy and Respiratory Unit, Hospital Universitario Dr. Balmis, ISABIAL, Alicante, Spain.ORCID 0000-0003-2388-0322
Mónica AntónAllergy Service, University Hospital Vinalopó, Elche, Alicante, Spain.
Carmen AndreuAllergy Service, Hospital Vega Baja, Orihuela, Alicante, Spain.
Ángel FerrerAllergy Service, Hospital Vithas, Alicante, Spain.ORCID 0000-0001-6567-053X
Isabel-María FloresAllergy Service, Hospital Elche, Elche, Spain.
Neus CerdáBioClever, Barcelona, Spain.
Sandra Del PozoInmunotek, S.L., Alcalá de Henares, Madrid, Spain.ORCID 0000-0001-5205-4105
Raquel CaballeroInmunotek, S.L., Alcalá de Henares, Madrid, Spain.ORCID 0000-0001-5012-0340
José Luis SubizaInmunotek, S.L., Alcalá de Henares, Madrid, Spain.ORCID 0000-0002-0134-5321
Miguel CasanovasInmunotek, S.L., Alcalá de Henares, Madrid, Spain.ORCID 0000-0003-2330-3963
Hospital Universitari i Politècnic La Fe · ESHospital General Universitario de Alicante Doctor Balmis · ESInmunotek (Spain) · ESHospital General Universitari de Castelló · ESHospital de Manises · ESHospital Universitario Doctor Peset · ESEsteve (Spain) · ESHospital General Universitario de Elche · ESHospital Universitari Arnau de Vilanova · ESHospital Universitario del Vinalopó · ESHospital Vega Baja · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPolymerized allergens conjugated to non-oxidized mannan (PM-allergoids) are novel vaccines targeting dendritic cells (DCs). Previous experimental data indicate that PM-allergoids are readily taken up by DCs and induce Treg cells. This first-in-human study was aimed to evaluate safety and to find the optimal dose of house dust mite PM-allergoid (PM-HDM) administered subcutaneously (SC) or sublingually (SL).

methodsIn a randomized, double-blind, double-dummy, placebo-controlled trial, 196 subjects received placebo or PM-HDM at 500, 1000, 3000, or 5000 mannan-conjugated therapeutic units (mTU)/mL in 9-arm groups for 4 months. All subjects received 5 SC doses (0.5 ml each) every 30 days plus 0.2 ml SL daily. The primary efficacy outcome was the improvement of titrated nasal provocation tests (NPT) with D. pteronyssinus at baseline and at the end of the study. All adverse events and reactions were recorded and assessed. Secondary outcomes were the combination of symptom and medication scores (CSMS) and serological markers.

resultsNo moderate or severe adverse reactions were reported. Subjects improving the NPT after treatment ranged from 45% to 62% in active SC, 44% to 61% in active SL and 16% in placebo groups. Statistical differences between placebo and active groups were all significant above 500 mTU, being the highest with 3000 mTU SL (p = 0.004) and 5000 mTU SC (p = 0.011). CSMS improvement over placebo reached 70% (p < 0.001) in active 3000 mTU SC and 40% (p = 0.015) in 5000 mTU SL groups.

conclusionsPM-HDM immunotherapy was safe and successful in achieving primary and secondary clinical outcomes in SC and SL at either 3000 or 5000 mTU/ml.

Indexed as

Sublingual ImmunotherapyVaccinesAllergensAllergoidsAnimalsAntigens, DermatophagoidesDermatophagoides pteronyssinusDouble-Blind MethodHumansMannansPyroglyphidaeTreatment OutcomeAllergensAllergoidsAntigens, DermatophagoidesMannansVaccinesallergoidclinical trialimannanmmunotherapypolymerized

Identifiers

PMID35570712
PMCPMC9796063
OpenAlexW4280608305

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.