Hookworm Disease
Conditions
Interventions
Sterile water
Sponsors
CERMEL
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subject is aged = 21 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 calls within 24 hours during the first 16 weeks of the study. 5. Subject is willing to refrain from blood donation procedures throughout the study period. 6. Subject has signed informed consent. 7. Subject is negative for helminth infections: PCR negative for hookworm and Strogyloides stercoralis; Negative for Ascaris lumbricoides, Trichuris trichuria, and Schistosoma spp by microscopy. Negative for Loa Loa by microscopy and blood concentration. 8. Subject is willing to remain in the study area throughout the trial period.
Exclusion criteria
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, hematological, 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 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 Hb value <7 g/dl; 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; inflammatory bowel syndrome; regular constipation, resulting in bowel movements less than three times per week. 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. Positive fecal PCR or Kato-Katz for hookworm at screening. 5. Current or past scars, tattoos.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Frequency and intensity of adverse events following single exposure to hookworm larvae 2. Detection of hookworm eggs by faeces microscopy (Kato-Katz) at any week between week 9 to 16 post-infection. 3. Humoral (antibody) and cellular immunological changes after controlled hookworm human infection. 4. Time to positive faeces test for hookworm as defined by Kato-Katz and PCR | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rates, subtypes and functions of antibodies after controlled human hookworm infection. 2. Innate and adaptive cell frequencies after controlled human hookworm infection. 3. Molecular mapping of Necator americanus Lambaréné strain. | — |
Countries
Gabon
Contacts
Public ContactAyodele ;Selidji Alabi;Agnandji
Clinical Investigator;Director of CERMEL
Outcome results
None listed