ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

CHHIM Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

autoimmune diseases

allergic diseases

Condition category

Condition code

Inflammatory and Immune System

Autoimmune diseases

Alternative and Complementary Medicine

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]

Other interventions

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Every 2nd week from week 0 to 12

Secondary outcome [1]

IgG1 antibody response in serum using ELISA

Timepoint [1]

Weeks 0, 4, 8, 12, 24, 36 & 48

Secondary outcome [2]

Immune cell profiling using spectral flow cytometry of whole blood and PBMC

Timepoint [2]

Weeks 0, 4, 8, 12, 24, 36 & 48

Secondary outcome [3]

Gut microbiota in stool

Timepoint [3]

Weeks 0, 4, 8, 12, 24, 36 & 48

Secondary outcome [4]

Metabolite profiling in stool

Timepoint [4]

Weeks 0, 4, 8, 12, 24, 36 & 48

Secondary outcome [5]

Metabolite profiling in blood

Timepoint [5]

Weeks 0, 4, 8, 12, 24, 36 & 48

Secondary outcome [6]

Skin imaging of administration site

Timepoint [6]

Once a week from Weeks 0 - 8

Secondary outcome [7]

Gut motility analysis via Smartpill

Timepoint [7]

Weeks 0, 6, 12 & 48

Secondary outcome [8]

IgE antibody response in serum using ELISA

Timepoint [8]

Weeks 0, 4, 8, 12, 24, 36 & 48

Secondary outcome [9]

Test the effect of hookworm on intestinal barrier function using a Sugar permeability test

Timepoint [9]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Wellington

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council

Address [1]

Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street (GPS: 50 Grafton Road), Grafton, Auckland 1010

Country [1]

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]

University

Name [1]

Otago University

Address [1]

23 Mein St, Newtown, Wellington 6242

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health & Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

11/06/2019

Ethics approval number [1]

Summary

Brief summary

Clinical studies for evaluating the potential therapeutic benefit of hookworm infection has been hampered by the lack of a defined source and production of hookworm larvae. We wish to optimise methods for the production of human hookworm which will allow for a consistent supply of good quality, well-characterised hookworm infective larvae, for conducting future clinical trials on a range of human autoimmune and allergic diseases.
Further, in-depth assessment of  the immunological phenotype human hookworm induces along with the gut bacterial and metabolic change in the human host will provide valuable insights on the cross-talk between the parasite and its host.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Stephen Inns

Address

Department of Medicine, University of Otago Wellington,
23 Mein St, Newtown, Wellington 6242, Wellington

Country

New Zealand

Phone

+6449186848

Fax

stephen.inns@otago.ac.nz

Contact person for public queries

Name

Mali Camberis

Address

Malaghan Institute of Medical Research
Gate 7, Victoria University Central Services Building, Kelburn, Wellington 6012

Country

New Zealand

Phone

+6444996914

Fax

mcamberis@malaghan.org.nz

Contact person for scientific queries

Name

Mali Camberis

Address

Malaghan Institute of Medical Research
Gate 7, Victoria University Central Services Building, Kelburn, Wellington 6012

Country

New Zealand

Phone

+6444996914

Fax

mcamberis@malaghan.org.nz

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

Source	Title	Year of Publication	DOI
Dimensions AI	Modulation of intestinal epithelial permeability by chronic small intestinal helminth infections	2024	https://doi.org/10.1111/imcb.12749

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically