Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001129178
Ethics application status
Approved
Date submitted
30/07/2019
Date registered
13/08/2019
Date last updated
28/08/2023
Date data sharing statement initially provided
13/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Therapeutic Hookworm Phenotyping Study
Scientific title
Establishing a controlled human hookworm Infection Model
Secondary ID [1] 298883 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CHHIM Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
autoimmune diseases 313849 0
allergic diseases 313850 0
Condition category
Condition code
Inflammatory and Immune System 312247 312247 0 0
Autoimmune diseases
Alternative and Complementary Medicine 312248 312248 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
15 infective Necator americanus hookworm larvae (NaiL3) will be applied to each forearm of volunteer for percutaneous administration. Total of 30 NaiL3 per volunteer. These will be applied by trained personnel in a medical research facility.
Intervention code [1] 315144 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320895 0
The detection of Necator americanus (Na) eggs in the stool of volunteers to confirm active Na infection via capsule endoscopy, PCR testing of blood and faecal sample for microscopic analysis. Once active Na infection is confirmed stool samples will be collected for the production and method optimisation of Na infective L3 larvae.
Timepoint [1] 320895 0
Every 2nd week from week 0 to 12
Secondary outcome [1] 373283 0
IgG1 antibody response in serum using ELISA
Timepoint [1] 373283 0
Weeks 0, 4, 8, 12, 24, 36 & 48
Secondary outcome [2] 373726 0
Immune cell profiling using spectral flow cytometry of whole blood and PBMC
Timepoint [2] 373726 0
Weeks 0, 4, 8, 12, 24, 36 & 48
Secondary outcome [3] 373727 0
Gut microbiota in stool
Timepoint [3] 373727 0
Weeks 0, 4, 8, 12, 24, 36 & 48
Secondary outcome [4] 373728 0
Metabolite profiling in stool
Timepoint [4] 373728 0
Weeks 0, 4, 8, 12, 24, 36 & 48
Secondary outcome [5] 373729 0
Metabolite profiling in blood
Timepoint [5] 373729 0
Weeks 0, 4, 8, 12, 24, 36 & 48
Secondary outcome [6] 373730 0
Skin imaging of administration site
Timepoint [6] 373730 0
Once a week from Weeks 0 - 8
Secondary outcome [7] 373731 0
Gut motility analysis via Smartpill
Timepoint [7] 373731 0
Weeks 0, 6, 12 & 48
Secondary outcome [8] 373784 0
IgE antibody response in serum using ELISA
Timepoint [8] 373784 0
Weeks 0, 4, 8, 12, 24, 36 & 48
Secondary outcome [9] 418268 0
Test the effect of hookworm on intestinal barrier function using a Sugar permeability test
Timepoint [9] 418268 0
Week -1 and weeks 8 & 24 post infection

Eligibility
Key inclusion criteria
Participant has provided written informed consent and is willing to comply with all protocol scheduled visits, laboratory tests, and other trial procedures and in the opinion of the investigator has a good understanding of the protocol, the length of the study and the demands of the study.
• Participants will be male and non-pregnant, non-lactating females aged between 18 to 65 years.
• Participants must weigh more than 50kg with a BMI within the 18.5 – 35kg/m2 range
• Participants must understand the procedures involved and agree to participate in the study by giving fully informed, written consent prior to any study assessment.
• Participants must be contactable and available for the duration of the clinical trial
• If female, has met either of criterion “a” or “b” below:
(a) If of non-childbearing potential, has met 1 of the following – Amenorrheic for at least 2 years, or has had a hysterectomy and/or bilateral oophorectomy at least 8 weeks prior to screening, or has had a tubal ligation at least 8 weeks prior to screening.
(b) If of childbearing potential, must be willing to use the acceptable methods of contraception
• In the opinion of the investigator is in good general health
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current or history of helminth infection (other than E. vermicularis).
• Have any finding at screening that in the opinion of the investigator or medical monitor would compromise the safety of the participant or affect their ability to adhere to protocol scheduled visits, treatment plan, laboratory tests, and other trial procedures.
11
• Have participated in any other clinical trial and/or have received an investigational drug or device within 30 days of screening.
• History or current evidence of any of the following: compromised respiratory function (chronic obstructive pulmonary disease, respiratory depression, signs or symptoms of hypoxia at screening); thyroid pathology (unless stabilized and euthyroid for >3 months at the time of screening); hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection; evidence of clinically significant chronic cardiac, hepatic or renal disease; psychiatric illness (poorly controlled); seizure disorder or any other chronic health issues that in the opinion of the investigator would exclude the participant from the trial.
• Have one of the following laboratory abnormalities: ferritin <20 ug/L, transferrin <2.04 g/L or Haemoglobin <120 g/L for females or 130 g/L for males.
• History of severe asthma or other health conditions that may require future steroid use;
• History of substance abuse or current substance abuse that in the opinion of the investigator would exclude the participant from the trial.
• History of intolerance, allergy or hypersensitivity to the proposed anthelmintic – mebendazole.
• History of intolerance, allergy or hypersensitivity to the Betadine (iodine) solution used in preparation of Na that in the opinion of the investigator would exclude the participant from the trial.
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years;
• For female subjects: positive urine pregnancy test at screening.
• Current or past scars, tattoos, or other disruptions of skin integrity at the intended site of larval application.
• Poor venous access making the participant unable to comply with the safety laboratory testing requirements.
• Antibiotic use within 6 months of screening or commencement during the study
• Probiotic or prebiotic supplementation within 1 month of screening or commencement during the study
• Laxative or gastric motility medication use within 1 month of screening or commencement during the study
• Significant dietary change or weight loss (>5%) within 6 months of screening or during the study
• Smokers or high alcohol consumers

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2019
Actual
14/10/2019
Date of last participant enrolment
Anticipated
Actual
26/01/2023
Date of last data collection
Anticipated
1/07/2023
Actual
1/07/2023
Sample size
Target
22
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 21729 0
New Zealand
State/province [1] 21729 0
Wellington

Funding & Sponsors
Funding source category [1] 303426 0
Government body
Name [1] 303426 0
Health Research Council
Country [1] 303426 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Malaghan Institute of Medical Research
Address
Gate 7, Victoria University
Central Services Building,
Kelburn Parade, Kelburn
Wellington, 6012
New Zealand
Country
New Zealand
Secondary sponsor category [1] 303475 0
University
Name [1] 303475 0
Otago University
Address [1] 303475 0
23 Mein St, Newtown, Wellington 6242
Country [1] 303475 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303957 0
Health & Disability Ethics Committee
Ethics committee address [1] 303957 0
Ethics committee country [1] 303957 0
New Zealand
Date submitted for ethics approval [1] 303957 0
Approval date [1] 303957 0
11/06/2019
Ethics approval number [1] 303957 0

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

Contacts
Principal investigator
Name 95374 0
Dr Stephen Inns
Address 95374 0
Department of Medicine, University of Otago Wellington,
23 Mein St, Newtown, Wellington 6242, Wellington
Country 95374 0
New Zealand
Phone 95374 0
+6449186848
Fax 95374 0
Email 95374 0
[email protected]
Contact person for public queries
Name 95375 0
Mali Camberis
Address 95375 0
Malaghan Institute of Medical Research
Gate 7, Victoria University Central Services Building, Kelburn, Wellington 6012
Country 95375 0
New Zealand
Phone 95375 0
+6444996914
Fax 95375 0
Email 95375 0
[email protected]
Contact person for scientific queries
Name 95376 0
Mali Camberis
Address 95376 0
Malaghan Institute of Medical Research
Gate 7, Victoria University Central Services Building, Kelburn, Wellington 6012
Country 95376 0
New Zealand
Phone 95376 0
+6444996914
Fax 95376 0
Email 95376 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
published results only
When will data be available (start and end dates)?
Start date 4th November 2020
No end date determined yet
Available to whom?
Researchers
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to the approval by Principal investigator


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
Dimensions AIModulation of intestinal epithelial permeability by chronic small intestinal helminth infections2024https://doi.org/10.1111/imcb.12749
N.B. These documents automatically identified may not have been verified by the study sponsor.