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Peanut AllergyPhase 1NCT02991885

HAL-MPE1 Safety and Tolerability Study

A Phase 1 study testing HAL-MPE1 in people with Peanut Allergy, run by HAL Allergy at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 5 to 50 years
Conditions the study is for
Peanut Allergy
What is being tested?
HAL-MPE1
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
7 sitesin 2 countries
Study dates
Dec 2016to Sep 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)
Show all 14Show fewer
  • 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.

Who cannot join

  • 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
Show all 30Show fewer
  • 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
  • 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 locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States6 sites

  • John Hopkins Hospital University-Divison of Pediatric Allergy

    Baltimore, Maryland, 21287

  • UNC Rheumatolory Allergy & Immunology Clinic

    Chapel Hill, North Carolina, 27517

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

    New York, New York, 10029

  • South Texas Allergy & Asthma Medical Professionals (STAAMP)

    San Antonio, Texas, 78251

  • Asthma, Inc.

    Seattle, Washington, 98105

  • Allergy, Asthma and Immunology Center

    Tulsa, Oklahoma, 74136

Other trials in United States

Canada1 site

  • Inflamax Research Limited

    Mississauga, Ontario, L4W 1A4

Other trials in Canada

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-centre Study to Assess the Safety, Tolerability and Immunologic Effects of HAL-MPE1 Subcutaneous Immunotherapy in Adult and Paediatric Subjects With Peanut Allergy

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.

Read the detailed description

At the time of the study there was no effective treatment available for peanut allergy other than avoidance of peanut allergens. There was 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.

Conditions
Peanut Allergy
Being tested
HAL-MPE1, HAL-MPE1 placebo
Medical subject headings
Peanut Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HAL-MPE1Biological

    Also called Modified peanut extract

    Weekly subcutaneous administrations of HAL-MPE1

  • HAL-MPE1 placeboDrug

    Also called Placebo for modified peanut extract

    Weekly subcutaneous administrations of HAL-MPE1 placebo

Study groups in NCT02991885
Study groupRoleWhat they receive
HAL-MPE1ExperimentalHAL-MPE1 is an off-white to white liquid suspension containing modified peanut extract
Receives: Biological: HAL-MPE1
HAL-MPE1 placeboPlacebo comparatorHAL-MPE1 placebo without modified peanut extract
Receives: Drug: HAL-MPE1 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of local and systemic reactions

    Occurrence of immediate (≤ hour), early (1-4) and late (> 4 hours) local and systemic reactions reactions

    Measured: within 30 minutes to >4 hours

  2. Occurrence of treatment emergent adverse events

    Treatment emergent adverse events will be collected by reporting of adverse events and by clinical relevant changes in laboratory values, vital signs, lung function and aluminum levels in plasma and urine

    Measured: Throughout study completion, an average 16 weeks

Secondary outcomes (3)

  1. Changes immunoglobulin levels

    Serum specific and component specific immunoglobulin levels

    Measured: Before and after 4, 8 and 16 weeks of treatment

  2. Changes in basophil activation

    In vitro determination of basophil activation upon antigen stimulation

    Measured: Before and after 16 weeks treatment

  3. Changes in histamine release test

    Determination of histamine release and total cellular histamine content induced by peanut

    Measured: Before and after 16 weeks treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionApr 2019
  4. Study completionSep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02991885
Sponsor's protocol ID
HAL-MPE1/0049
Status last verified
Feb 2020
First submitted
21 Nov 2016
Last updated
19 Feb 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Reyes AJ, Hosein AS, Ramcharan K, Perot S. Anaphylaxis and other allergic reactions to food: a global challenge. BMJ Case Rep. 2020 May 14;13(5):e231425. doi: 10.1136/bcr-2019-231425.

    PubMed 32414772

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HAL-MPE1 in people with Peanut Allergy, run by HAL Allergy at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of local and systemic reactions (time frame: within 30 minutes to >4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02991885, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.

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HAL-MPE1 Safety and Tolerability Study (NCT02991885) | AzTrials