Study of the efficacy of the LTP allergy (peach, peanut, artemisia and olive) vaccine .

Randomized double-blind, placebo-controlled study evaluate the efficacy and mechanisms involved in immunotherapy Sublingual specifies with Pru p 3 (Pru p 3-ITSL) in patients with allergy to nsLTP with severe symptoms in its response to Peach, peanut, artemisia and olive.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-005038-53-ES

Enrollment

Registered

2018-11-23

Start date

2019-05-16

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

LTP syndrome. MedDRA version: 20.0 Level: PT Classification code 10016946 Term: Food allergy System Organ Class: 10021428 - Immune system disorders

Interventions

Trade Name: SLIT-Melocotón Product Name: SLIT Melocotón Pharmaceutical Form: Concentrate for oral solution INN or Proposed INN: Pru p 3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Informed Consent (IC) for the study and for the Biobank signed 2. Men or women =5 and =55 years of age. 3. Moderate/severe allergic reaction after ingestion of peach, with or without peanut, confirmed by PPDCCP with peach. Are the trial subjects under 18? yes Number of subjects for this age range: 33 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 66 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Pregnancy and lactation. 2. Immunological diseases, treatments with immunomodulators and/or blockers. 3. Mental illness. 4. Severe atopic dermatitis according to SCORAD (53) 5. FEV1 <70%. 6. Inflammation in the oral cavity with severe symptoms, oral surgery in the previous 7 days.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the efficacy and safety of specific sublingual immunotherapy with Pru p 3 (SLIT-Prup3) in patients with allergy to nsLTP with severe symptoms in their response to peach, peanut, artemisia and olive trees by conducting controlled double-blind challenge with placebo (CDBCP) and/or specific nasal provocation test.; Secondary Objective: Monitor the immunological changes during the ITSL-Prup3 and after the completion (one year of treatment) of the same at different levels: a) In vivo: Evaluating changes in sensitization to peach, peanut, artemisia and olive trees, by analyzing the reactivity in intraepidermal tests with allergenic extracts, CDBCP against peach and peanut and by specific nasal provocation test against a p3 p, Art v 3, Ole e 7, artemisia and olive tree. b) In vitro: b.1) Humoral. Analyzing changes in the levels of IgE and IgG4 specific to different nsLTPs (Pru p 3, Ara h 9, Art v 3 and Ole e 7) as well as Art v 1 and Ole e 1 (major allergens of artemisia and olive tree) will be used to assess primary awareness of these pollens. b.2) Cellular. Assessing changes in CD maturation and in the proliferation of different effector and regulatory cell subpopulations specific to the different nsLTPs. The changes in subpopulation apoptosis will be analyzed. ; Primary end point(s): Evaluation of the in vivo response - Skin tests - Specific nasal provocation test - CDBCP with Peach and Peanut ; Timepoint(s) of evaluation of this end point: - Skin tests: Screening period, 1, 6 and 12 months of treatment. - Specific nasal provocation test & CDBCP with Peach and Peanut: Screening period and 12 months.	—

Measure

Time frame

Main Objective: Evaluate the efficacy and safety of specific sublingual immunotherapy with Pru p 3 (SLIT-Prup3) in patients with allergy to nsLTP with severe symptoms in their response to peach, peanut, artemisia and olive trees by conducting controlled double-blind challenge with placebo (CDBCP) and/or specific nasal provocation test.; Secondary Objective: Monitor the immunological changes during the ITSL-Prup3 and after the completion (one year of treatment) of the same at different levels: a) In vivo: Evaluating changes in sensitization to peach, peanut, artemisia and olive trees, by analyzing the reactivity in intraepidermal tests with allergenic extracts, CDBCP against peach and peanut and by specific nasal provocation test against a p3 p, Art v 3, Ole e 7, artemisia and olive tree. b) In vitro: b.1) Humoral. Analyzing changes in the levels of IgE and IgG4 specific to different nsLTPs (Pru p 3, Ara h 9, Art v 3 and Ole e 7) as well as Art v 1 and Ole e 1 (major allergens of artemisia and olive tree) will be used to assess primary awareness of these pollens. b.2) Cellular. Assessing changes in CD maturation and in the proliferation of different effector and regulatory cell subpopulations specific to the different nsLTPs. The changes in subpopulation apoptosis will be analyzed. ; Primary end point(s): Evaluation of the in vivo response - Skin tests - Specific nasal provocation test - CDBCP with Peach and Peanut ; Timepoint(s) of evaluation of this end point: - Skin tests: Screening period, 1, 6 and 12 months of treatment. - Specific nasal provocation test & CDBCP with Peach and Peanut: Screening period and 12 months.

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Secondary

Measure	Time frame
Secondary end point(s): Sensibilización in vitro frente a Pru p 3, Ara h 9, Art v3, Ole e 7, Ole e 1 y Art v 1.; Timepoint(s) of evaluation of this end point: V0, V1, V2, V3 y V4 Visit 0 (Screening) , V1 (start of treatment) , V2 (1 month of treatment), V3 (6 months of treatment) and V4 (12 months of treatment)	—

Countries

Spain

Contacts

Public ContactPlataforma de Estudios Clínicos

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina Y Salud (FIMABIS)

estudios.clinicos@fimabis.org34951291977

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026