| Eligibility |
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the
following criteria:
1. Subject is aged = 18 and = 45 years.
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. Subjects are able to respond to phone or email within 24 hours during the first 12
weeks of the study.
5. Subject agrees to refrain from blood donation to Sanquin or for other purposes
throughout the study period.
6. For female subjects: subject agrees to use adequate contraception and not to
breastfeed for the duration of study.
7. Subject has signed informed consent
A potential subject who meets any of the following criteria will be excluded from
participation in this study:
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:
- history of severe asthma or other health conditions that may require future
steroid use;
- body weight <50 kg or Body Mass Index (BMI) <18.0 or >30.0 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 <10 ug/L,
transferrine <2.04 g/L or Hb <7.5 mmol/L for females or <8.5 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 type 1 hypersensitivity to amphotericin B or gentamicin.
4. For female subjects: positive urine pregnancy test at screening.
5. Positive faecal PCR 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 with a stay in non-hygienic
environment during this trial.
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