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

Phase 1

• Conditions: TP syndrome.; MedDRA version: 20.0 Level: PT Classification code 10016946 Term: Food allergy System Organ Class: 10021428 - Immune system disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2017-005038-53-ES
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina Y Salud (FIMABIS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-23
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 99

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified