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Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy

Study Purpose

The purpose of this trial is to assess the safety and efficacy of peanut immunotherapy in children and adults with peanut allergy. Participants will receive immunotherapy with peanut every 2 weeks for a period of 3 months.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 12 Years - 45 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Informed Consent as documented by signature. 2. Male or female subjects 12 to 45 years old at screening visit. 3. Patients with convincing history of IgE-mediated systemic allergic reaction after consumption of peanut, and specific IgE above 95% positive predictive value: a. Peanut ≥ 15kU/L or Ara h 2 ≥ 5U/L. 4. Patients without a convincing history of IgE-mediated systemic allergic reaction (for example only oral symptoms) after consumption of peanuts but with clear evidence of sensitization (SPT > 3 mm and/or positive specific IgE (> 0.1kU/l) and a positive standardized food challenge to peanut between V0 and V1.

Exclusion Criteria:

1. Subjects with a history of severe anaphylaxis to the incriminated food with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence). 2. Subjects with a history of systemic reaction to peanutskin prick test with commercial extract. 3. Uncontrolled asthma (Forced expiratory volume at one second (FEV1) <70% of predicted value), active eosinophilic oesophagitis or any condition deemed incompatible by the investigator. 4. Known or suspected systemic mastocytosis. 5. Subject currently under allergen immunotherapy. 6. Subject/parent with excessive anxiety unlikely to cope with study conditions as per investigator's opinion. 7. Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study. 8. Use of immunosuppression or immunomodulatory drug (including anti-IgE or anti-Tumor necrosis factor (TNF)) within 1 year prior to inclusion in study. 9. Relative counter-indication or inability to use epinephrine auto-injector. 10. Subjects receiving beta-blockers or angiotensin converting-enzyme (ACE) inhibitors. 11. Women who are pregnant or breast feeding. 12. Intention to become pregnant during the course of the study, or inadequate contraceptive measures for women of child-bearing age (contraceptive measures considered adequate are: intrauterine devices, hormonal contraceptives, such as contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release). 13. Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.). 14. Diseases with a contraindication for the use of adrenalin (e.g. hyperthyroidism, glaucoma). 15. Known or suspected non-compliance, drug or alcohol abuse. 16. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant. 17. Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigators

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Geneva
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jean-Christoph Caubet, MD
Principal Investigator Affiliation University Hospitals of Geneva
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Switzerland

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy, Peanut Allergy
Arms & Interventions


Experimental: Peanut allergenic extract

injected peanut extract.


Drug: - Peanut Immunotherapy

Treatment will be injected peanut extract every 2 weeks for a period of 3 months.

Contact a Trial Team

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International Sites

Geneva, Switzerland




Pediatric allergy unit, Hôpitaux Universitaires de Genève (HUG)

Geneva, , 1211

Site Contact

Jean-Christoph Caubet, MD


+41 79 553 40 85

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