None listed
Conditions
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.
Interventions
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.
Sponsors
Malaghan Institute of Medical Research
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed