HAL-MPE1 Safety and Tolerability Study

Completed · Phase 1 · Has a placebo group

Conditions studied: Peanut Allergy

In brief

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.

Key facts

Study ID: NCT02991885
Run by: HAL Allergy
People needed: 42
Starts: 2016-12-01
Expected to finish: 2019-09-01
Last updated by the study team: 2020-02-19

Who can join

Age: 5 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 Immunoglobulin E (IgE)-test (>2.0 kU/L)
Skin prick test (SPT) to peanut ≥3 mm compared to negative control within the last 2 years
Forced expiratory volume at first second (FEV1)>80% predicted (adults and adolescents) or Peak expiratory flow(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 Investigational Medicinal Product (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.

You may not qualify if…

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, Sublingual Immunotherapy (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 angiotensin-converting enzyme (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-Tumor Necrosis Factor (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

Where it is running

John Hopkins Hospital University-Divison of Pediatric Allergy — Baltimore, Maryland, United States
Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai — New York, New York, United States
UNC Rheumatolory Allergy & Immunology Clinic — Chapel Hill, North Carolina, United States
Allergy, Asthma and Immunology Center — Tulsa, Oklahoma, United States
South Texas Allergy & Asthma Medical Professionals (STAAMP) — San Antonio, Texas, United States
Asthma, Inc. — Seattle, Washington, United States
Inflamax Research Limited — Mississauga, Ontario, Canada

Full record on ClinicalTrials.gov

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