Safety and Tolerability of Vaccination with Attenuated Hookworm Larvae in Healthy Volunteers

Completed

• Conditions: Hookworm infection; Infection - Other infectious diseases

• Registration Number: ACTRN12617001007325
• Lead Sponsor: QIMR Berghofer Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-12
• Study Completion: 2018-10-24
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Participants will be males and non-pregnant, non-lactating females aged between 18 and 65 years.
Participants must have BMI within the range of 18-35 kg/m2 and weigh more than 50 kg.
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 and be available for up to 2 months following completion of the trial.
Female volunteers of childbearing potential, should be irreversibly surgically sterile (tubal ligation) with or without hysterectomy at least 6 months ago or be using injectable, insertable, transdermal or combination oral contraceptive approved by the Therapeutic Goods Administration (TGA) combined with barrier contraception (female condom or male partners to use condom) through completion of the study and have negative urinary pregnancy tests prior to albendazole use. Menopausal participants (confirmed by follicle-stimulating hormone [FSH]) do not require contraception.

Exclusion Criteria

History of Helminth infection (other than E. vermicularis) or travel to and residence (greater than 2 weeks) in areas of endemic transmission of these parasites.
History of atopy or severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
History of allergic reaction, anaphylaxis or otherwise to iodine, amphotericin, albendazole, chilli or other peppers, or Tabasco sauce.
Treatment with immune-modulating medications in the last 6 months.
Current iron deficiency anaemia.
Any vaccination in the last 30 days.
Heavily tattooed forearms

Study & Design

• Study Type: Interventional
• Study Design: Not specified