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.
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)
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- 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
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 group | Role | What they receive |
|---|---|---|
| HAL-MPE1 | Experimental | HAL-MPE1 is an off-white to white liquid suspension containing modified peanut extract Receives: Biological: HAL-MPE1 |
| HAL-MPE1 placebo | Placebo comparator | HAL-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.
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
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)
Changes immunoglobulin levels
Serum specific and component specific immunoglobulin levels
Measured: Before and after 4, 8 and 16 weeks of treatment
Changes in basophil activation
In vitro determination of basophil activation upon antigen stimulation
Measured: Before and after 16 weeks treatment
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.
- First posted14 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionApr 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- HAL Allergy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Wood, MD, Principal investigator, John Hopkins Hospital Unversity-Divison of Pediatric AllergyScott Sicherer, MD, Principal investigator, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount SinaiEdwin Kim, MD, Principal investigator, UNC Rheumatolory Allergy & Immunology Clinic
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02991885
- Acronym / sponsor ID
- HAL-MPE1/0049
- Conditions
- Peanut Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- HAL AllergyIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAL-MPE1 | Experimental | Biological: HAL-MPE1HAL-MPE1 is an off-white to white liquid suspension containing modified peanut extract |
| HAL-MPE1 placebo | Placebo comparator | Drug: HAL-MPE1 placeboHAL-MPE1 placebo without modified peanut extract |
Who may qualify
- Ages
- 5 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (30 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAL-MPE1Also: Modified peanut extractWeekly subcutaneous administrations of HAL-MPE1 | Biological | HAL-MPE1 |
| HAL-MPE1 placeboAlso: Placebo for modified peanut extractWeekly subcutaneous administrations of HAL-MPE1 placebo | Drug | HAL-MPE1 placebo |
Primary outcome
Occurrence of local and systemic reactions
Time frame: within 30 minutes to >4 hours
Occurrence of immediate (≤ hour), early (1-4) and late (> 4 hours) local and systemic reactions reactions
Occurrence of treatment emergent adverse events
Time frame: Throughout study completion, an average 16 weeks
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
3 secondary outcomes
Changes immunoglobulin levels
Time frame: Before and after 4, 8 and 16 weeks of treatment
Changes in basophil activation
Time frame: Before and after 16 weeks treatment
Changes in histamine release test
Time frame: Before and after 16 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Derived from this study: PubMed 32414772Reyes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wood, MD principal investigator
John Hopkins Hospital Unversity-Divison of Pediatric Allergy
Scott Sicherer, MD principal investigator
Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai
Edwin Kim, MD principal investigator
UNC Rheumatolory Allergy & Immunology Clinic
7 sites in 2 countries: see every site and its status.
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.