Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000692336
Ethics application status
Approved
Date submitted
10/05/2017
Date registered
15/05/2017
Date last updated
13/11/2018
Date data sharing statement initially provided
13/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of the safety of a novel treatment (PVX108) for peanut allergy, conducted in peanut-allergic adults
Scientific title
Phase I trial to assess the safety and tolerability of PVX108 in peanut allergic adults
Secondary ID [1] 291764 0
None
Universal Trial Number (UTN)
U1111-1195-9000
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peanut allergy 302991 0
Condition category
Condition code
Inflammatory and Immune System 302457 302457 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PVX108 comprises an equimolar solution of unmodified synthetic peptides representing T cell epitope sequences from major peanut allergens (Ara h 1 and Ara h 2). It is administered by intradermal injection.

In Stage 1 of the trial, up to eight cohorts of six subjects will receive single injections of PVX108 or matched placebo (2:1). The first cohort will receive a dose of 0.05nmol. If the dose is well tolerated, the dose will be escalated in the next cohort up to a maximum of 150nmol in cohort 8.

In Stage 2 of the trial, 18 subjects will receive six injections of PVX108 or matched placebo (2:1) at week 0, 2, 4, 8, 12, and 16. Dosing will commence at the safe starting dose identified in Stage 1, and if well tolerated will be escalated up to a maximum of 150nmol. The maximum total duration of treatment will be 16 weeks.
Intervention code [1] 297879 0
Treatment: Drugs
Comparator / control treatment
This is a double-blind, placebo-controlled study. PVX108 placebo solution has the same composition as PVX108, but does not contain any active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 301871 0
To determine the safety and tolerability of single doses of PVX108 in peanut allergic adults, by assessment of adverse events monitored in clinic for at least 24 hours following administration, and then at home for 7 days. Spirometry and peak expiratory flow will be used to assess affects of treatment on respiratory function whilst in the clinic.
Timepoint [1] 301871 0
Safety and tolerability will be monitored in clinic for at least 24 hours following administration, and adverse events assessed over 7 days.
Primary outcome [2] 301872 0
To determine the safety and tolerability of multiple (n=6), escalating intradermal doses of PVX108 in peanut allergic adults, by assessment of adverse events monitored in clinic for at least 24 hours following the first administration, and in clinic monitoring for 8 hours following the subsequent administrations. Adverse events occurring at home will be monitored for the duration of treatment. Spirometry and peak expiratory flow will be used to assess affects of treatment on respiratory function whilst in the clinic.
Timepoint [2] 301872 0
Safety and tolerability will be monitored in clinic for at least 8 hours following each administration, and adverse events assessed over a 16 week duration of treatment.
Secondary outcome [1] 334169 0
Exploratory Outcome to investigate potential biomarkers of disease and blood borne signals of the effects of PVX108 therapy from blood samples collected prior to, during and after therapy. Samples will be collected in both Stage 1 and Stage 2 of the trial in order to investigate the effects of single, and repeated administrations of PVX108, respectively.
Timepoint [1] 334169 0
In Stage 1, Blood samples will be collected prior to and a week after administration of PVX108. In Stage 2, blood samples will be collected prior to, and approximately 28 days and 141 days following the commencement of PVX108 treatment.

Eligibility
Key inclusion criteria
1. Males or females aged 18 to 65 years inclusive at the time of consent
2. Documented history of allergic reactivity to peanut regardless of severity
3. Positive response to peanut in a basophil activation test
4. Peanut-specific serum immunoglobulin E (IgE) measured by ImmunoCAP (Registered Trademark) >0.35 kUA/L
5. Positive skin prick test (SPT) to peanut with a wheal diameter at least 3 mm, unless in the opinion of the investigator, it is unsafe to perform a SPT
6. Spirometry testing lung function within the normal range, Forced Expiratory Volume in 1 second (FEV1) at least 80% of predicted at Screening and Visit 1
7. Bronchodilator reversibility test with change in FEV1 less than 12% and less than 200 mL
8. Female subjects must be:
a. of non child-bearing potential [surgically sterilised or post–menopausal (12 months with no menses without alternative medical cause)] OR
b. not pregnant, breast feeding or planning to become pregnant AND willing to comply with the medically acceptable contraceptive requirements of the study from Screening to at least 28 days after the last Investigational Medicinal Product (IMP) administration
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of or current clinically-significant gastrointestinal, hepatic, renal, cardiovascular, endocrine, oncological, immunological, neurological, ophthalmological, haematological, respiratory or psychiatric disorder or any other condition, which in the opinion of the investigator or sponsor would jeopardise the safety of the subject or the validity of the study results
2. Random serum tryptase reading less than 11.4 ng/mL
3. Severe or unstable asthma
4. History of respiratory related life threatening events or life threatening anaphylaxis in the last 12 months
5. Subjects with skin disorders that would hinder skin testing and/or its interpretation (eg severe generalised active atopic dermatitis)
6. Subjects unable to receive beta-2-agonist or anticholinergics that could hinder treatment of an asthmatic response
7. Use of beta blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers, systemic (oral or injectable) corticosteroids within 2 months prior to Day 1
8. Prior participation in any interventional study aimed at desensitising peanut allergy within the last 5 years
9. Subject who received any specific immunotherapy for allergy during the past 12 months, or plans to receive during the course of the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A randomisation code is generated by an unblinded study statistician who is a staff member of the contracted CRO and has no involvement with site operations. Study medication is labelled as "PVX108 Active or Placebo" with a randomisation and kit number, and packed by unblinded staff at the manufacturing facility according to the randomisation schedule generated by the study statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Safety data will be summarised descriptively by treatment group at each available time point.
Categorical data will be summarised as frequency, and percentage; continuous data will be summarised as mean, standard deviation, minimum, median, and maximum as appropriate.
No formal hypothesis tests or statistical models are planned.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/05/2017
Date of last participant enrolment
Anticipated
25/05/2018
Actual
22/06/2018
Date of last data collection
Anticipated
30/11/2018
Actual
9/11/2018
Sample size
Target
66
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7895 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment hospital [2] 8115 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 16172 0
3004 - Melbourne
Recruitment postcode(s) [2] 15851 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 296266 0
Commercial sector/Industry
Name [1] 296266 0
Aravax Pty Ltd
Country [1] 296266 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Aravax Pty Ltd
Address
Level 9, 31 Queens St, Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 295213 0
None
Name [1] 295213 0
Address [1] 295213 0
Country [1] 295213 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297501 0
Bellberry HREC
Ethics committee address [1] 297501 0
Ethics committee country [1] 297501 0
Australia
Date submitted for ethics approval [1] 297501 0
08/03/2017
Approval date [1] 297501 0
10/04/2017
Ethics approval number [1] 297501 0
2017-03-176
Ethics committee name [2] 297775 0
The Alfred Hospital Ethics Committee
Ethics committee address [2] 297775 0
Ethics committee country [2] 297775 0
Australia
Date submitted for ethics approval [2] 297775 0
19/05/2017
Approval date [2] 297775 0
18/05/2017
Ethics approval number [2] 297775 0
127/17

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74242 0
Dr Nicholas Farinola
Address 74242 0
CMAX Clinical Research.
Level 5, 18a North Terrace,
Adelaide SA 5000
Country 74242 0
Australia
Phone 74242 0
+61 8 7088 7900
Fax 74242 0
+61 8 7088 7999
Email 74242 0
Nicholas.Farinola@sa.gov.au
Contact person for public queries
Name 74243 0
Pascal Hickey
Address 74243 0
Aravax Pty Ltd. Level 9, 31 Queens St. Melbourne VIC 3000
Country 74243 0
Australia
Phone 74243 0
+61 3 9657 0700
Fax 74243 0
+61 3 9657 0777
Email 74243 0
pascal.hickey@aravax.com.au
Contact person for scientific queries
Name 74244 0
Sara Prickett
Address 74244 0
Aravax Pty Ltd. Level 9, 31 Queens St. Melbourne VIC 3000
Country 74244 0
Australia
Phone 74244 0
+61 3 9657 0700
Fax 74244 0
+61 3 9657 0777
Email 74244 0
sara.prickett@aravax.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
We need to understand what is being requested before committing an answer


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCurrent and Future Treatment of Peanut Allergy.2019https://dx.doi.org/10.1016/j.jaip.2018.11.049
EmbaseAdvances in management of food allergy in children.2020https://dx.doi.org/10.2174/1573396316666191227122917
Dimensions AIB cells and food allergy2021https://doi.org/10.1097/mop.0000000000001050
N.B. These documents automatically identified may not have been verified by the study sponsor.