Repeated Controlled Human Hookworm Infection in Healthy Dutch Volunteers

Completed

• Conditions: Hookworm infection; parasitic infection; 10019381

• Registration Number: NL-OMON47227
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-09-04
• Results First Posted: 2019-09-19
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Subject is aged * 18 and * 45 years and in good health.
2. Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
3. Subject is able to communicate well with the investigator, is available to attend all study visits.
4. Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period.
5. For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.
6. Subject has signed informed consent.

Exclusion Criteria

1. Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immune-deficient, psychiatric and other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following:
* Body Mass Index (BMI) <18.0 or >35.0 kg/m2 at screening;
* positive HIV, HBV or HCV screening tests;
* the use of immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period;
* Having one of the following laboratory abnormalities: ferritine <10ug/L, transferrine <2.04g/L or Hb <7.0 mmol/L for females or <8.0 mmol/L for males.
* history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years;
* any history of treatment for severe psychiatric disease by a psychiatrist in the past year;
* history of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset.
2. Known hypersensitivity to or contra-indications for use of albendazole. Including co-medication known to interact with albendazole metabolism (e.g. carbamazepine, phenobarbital, phenytoin, cimetidine, theophylline, dexamethasone)
3. Known allergy to amphotericin B or gentamicin.
4. For female subjects: positive urine pregnancy test at screening.
5. Positive faecal qPCR or Kato-Katz for hookworm at screening, any known history of hookworm infection or treatment for hookworm infection or possible exposure to hookworm in the past.
6. Being an employee or student of the department of parasitology of the LUMC.
7. Current or past scars, tattoos, or other disruptions of skin integrity at the intended site of larval application.
8. Subjects with planned travel to hookworm endemic areas during this trial
9. Receipt of a vaccine within 4 weeks prior to the study initiation
10. Known food allergy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Frequency and magnitude of adverse events as compared between study groups A, B<br /><br>and C.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints<br /><br>* Variability in egg secretion by Kato-Katz from week 16 to 20<br /><br>* The lowest dose at which there is 100% patent hookworm infection, as defined<br /><br>by a positive Kato-Katz at any time between week 16 to 20<br /><br>* Comparison of the average number of eggs secreted by Kato-Katz and qPCR<br /><br>between different groups in weeks 16-20 after the infection<br /><br>* Humoral (antibody) and cellular immunological changes after controlled human<br /><br>hookworm infection.<br /><br><br /><br>Exploratory endpoints<br /><br>* Changes in metabolomic profile in urine, serum, and faeces after CHHI<br /><br>* Changes in gut microbiome after CHHI<br /><br>* Time to positive faeces test for hookworm as defined by Kato-Katz and qPCR<br /><br>* Changes in lactose/mannitol ratio and related biomarkers of intestinal<br /><br>permeability (i.e. serum zonulin, serum LPS) and intestinal inflammation (i.e.<br /><br>fecal calprotectin, serum diamine oxidase) after CHHI</p><br>