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HAL-MPE1 Safety and Tolerability Study

Study Purpose

The aim of this study is to confirm safety and tolerability of incremental doses of HAL-MPE1 subcutaneous immunotherapy (SCIT) in peanut allergic adults, and subsequently assess the safety and tolerability in adolescents and children with peanut allergy.

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 5 Years - 50 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Signed informed consent/assent - Male or female subjects aged 5- 50 years - A well-documented medical history of systemic reactions after ingestion of peanut - Positive serum specific anti-peanut (>5.0 kU/L) and Ara h 2 IgE-test (>2.0 kU/L) - Skin prick test (SPT) to peanut ≥3 mm compared to negative control within the last 2 years - FEV1>80% predicted (adults and adolescents) or PEF>80% predicted (children) - Negative pregnancy test at screening for females of childbearing potential Females of childbearing age must be using an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study.
Contraceptive measures considered adequate are:
  • - hormonal contraceptives such as contraceptive pills, transdermal patches, intrauterine device (IUD), intrauterine system (IUS) implant, or vaginal ring (started - least 4 weeks prior to IMP administration) - double barrier methods: e.g. condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent - surgical sterilization of the female participant (removal of the uterus or ovaries or tubal ligation) - participants who are postmenopausal (12 consecutive months without a period) for at least 2 years - male partner sterilization (vasectomy with documentation of azoospermia) prior to the female patient's entry into trial and is the sole sexual partner for that female patient - sexual abstinence or having no sexual relationship with a man.

Exclusion Criteria:

  • - Subjects with a history of severe anaphylaxis to peanut with the following symptoms: hypotension, neurological compromise (collapse, loss of consciousness or incontinence) after ingestion of peanuts - Baseline serum tryptase level >20 µg/l - Known allergy or hypersensitivity to an excipient in the study drug or placebo - Clinical features of moderate or severe persistent asthma (as guided by the 2007 NHLBI Guidelines and according to the opinion of the investigator) - Asthma with FEV1<80% predicted (adults, adolescents) or PEF <80% predicted (children) - Asthma Control Test (ACT) ≤ 19 - Asthma attack/exacerbation within the last 3 months - Hospitalization due to asthma within the last year - Two or more courses of oral steroids within the last 6 months - History of intubation /mechanical ventilation due to allergies or asthma - Participation in any interventional study with peanut immunotherapy in the last year - Any specific immunotherapy (SCIT, SLIT or OIT) during the study period - Severe immune disorders (including autoimmune diseases) and/or diseases requiring immunosuppressive drugs - Presence of chronic urticaria, atopic dermatitis with flare or atopic dermatitis with SCORAD>40 - Active malignancies or any malignant disease within the past 5 years - Severe (uncontrolled) diseases that could increase the risk for subjects participating in the study, including but not limited to: any severe or unstable lung diseases; endocrine diseases; clinically significant renal or hepatic diseases, renal impairment, haematological disorders; severe ongoing symptomatic allergic diseases - History of cardiovascular disease, uncontrolled hypertension or arrhythmias - Diseases with a contraindication for the use of epinephrine (e.g. hyperthyroidism, glaucoma) - Use of systemic steroids within 4 weeks before start of the study and during the study - Treatment with beta-blockers or ACE inhibitors - Vaccination within one week before start of therapy or during study unless considered necessary based on the opinion of the investigator.
- Anti-IgE/anti-TNF/omalizumab therapy or any biologic immunomodulatory therapy within the 6 months prior to inclusion and during the study - 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 - For female adolescents and adults of childbearing potential: Pregnancy (test performed at screening), lactation 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, sexual abstinence or having no sexual relationship with a man) - Alcohol, drug or medication abuse within the past year - Any clinically significant abnormal laboratory parameter at screening - Lack or expected lack of cooperation or compliance - Unable to use the epinephrine pen correctly - Severe psychiatric, psychological, or neurological disorders - Subjects who are employees of the sponsor, institution or 1st degree 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
Lead Sponsor

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

HAL Allergy
Principal Investigator

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

Robert Wood, MDScott Sicherer, MDEdwin Kim, MD
Principal Investigator Affiliation John Hopkins Hospital Unversity-Divison of Pediatric AllergyJaffe Food Allergy Institute, Icahn School of Medicine at Mount SinaiUNC Rheumatolory Allergy & Immunology Clinic
Agency Class

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

Overall Status Active, not recruiting
Countries Canada, United States

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

Peanut Allergy
Additional Details

Currently, there is no effective treatment for peanut allergy other than avoidance of peanut allergens. There is high unmet medical need for a disease modifying treatment for peanut allergy, especially for peanut allergic children, since this age group is at highest risk of peanut-related anaphylaxis requiring hospitalization. A chemically modified, aluminum hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous administration has been developed. The safety and tolerability of HAL-MPE1 have been established in a First-in-human (FIH) study in adults.

Arms & Interventions


Experimental: HAL-MPE1

HAL-MPE1 is an off-white to white liquid suspension containing modified peanut extract

Placebo Comparator: HAL-MPE1 placebo

HAL-MPE1 placebo without modified peanut extract


Biological: - HAL-MPE1

Weekly subcutaneous administrations of HAL-MPE1

Drug: - HAL-MPE1 placebo

Weekly subcutaneous administrations of HAL-MPE1 placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Baltimore, Maryland



John Hopkins Hospital University-Divison of Pediatric Allergy

Baltimore, Maryland, 21287

New York, New York



Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Chapel Hill, North Carolina



UNC Rheumatolory Allergy & Immunology Clinic

Chapel Hill, North Carolina, 27517

Allergy, Asthma and Immunology Center, Tulsa, Oklahoma



Allergy, Asthma and Immunology Center

Tulsa, Oklahoma, 74136

San Antonio, Texas



South Texas Allergy & Asthma Medical Professionals (STAAMP)

San Antonio, Texas, 78251

Asthma, Inc., Seattle, Washington



Asthma, Inc.

Seattle, Washington, 98105

International Sites

Inflamax Research Limited, Mississauga, Ontario, Canada



Inflamax Research Limited

Mississauga, Ontario, L4W 1A4

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