An interventional study of 50 Necator americanus L3 larvae and 100 Necator americanus L3 larvae in Necator Americanus Infection, sponsored by Meta Roestenberg. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-18.
Sponsored by Meta Roestenberg · Not applicable, Interventional, and Diagnostic
Twenty-four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus larvae for a maximum of three times.
Twenty-four volunteers will be allocated equally into three groups (i.e. group A, B, C). Group A, B, and C will have one, two, and three infections respectively. Every infection will be performed with 50 L3 Necator americanus larvae. Group A will receive infection at week 4 only. Group B will be infected at week 2 and week 4. Group C will be infected at week 0, 2 and 4. To maintain blinding, group A and B will receive mock infections with water at week 0 and week 0 and 2 respectively. The interval between each CHHI is 2 weeks. Before every infection, the safety will be assessed by a review of adverse events data with a local safety monitor.
Sixteen weeks after the last infection (week 20), all volunteers will be offered treatment with a 3-day regimen of albendazole to abrogate infection. Volunteers with average egg counts >250 eggs per gram will be asked if they would be willing to keep their infection for a maximum of two years (chronic donors). No more than four volunteers will be selected to be chronic donors. Six months after the last infection (or after the last donation for the chronic donors) volunteers will undergo their last visit.
Exclusion Criteria:
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:
Mock infections with water at week 0 and 2, infection with 50 Necator americanus L3 larvae at week 4
Biological: 50 Necator americanus L3 larvae
Mock infections with water at week 0, infection with 50 Necator americanus L3 larvae at week 2 and 4
Biological: 100 Necator americanus L3 larvae
Infection with 50 Necator americanus L3 larvae at week 0, 2 and 4
Biological: 150 Necator americanus L3 larvae
1x50 Necator americanus L3 larvae
2x50 Necator americanus L3 larvae
3x50 Necator americanus L3 larvae
Frequency of adverse events
Frequency of adverse events as compared between study groups A, B and C.
Time frame: 28 weeks
Magnitude of adverse events
Magnitude of adverse events as compared between study groups A, B and C.
Time frame: 28 weeks
Variability in egg secretion
Variability in egg secretion by Kato-Katz from week 16 to 20
Time frame: 20 weeks
Lowest dose at which there is 100% patent hookworm infection
The lowest dose at which there is 100% patent hookworm infection, as defined by a positive Kato-Katz at any time between week 16 to 20
Time frame: 20 weeks
Comparison of the average number of eggs secreted
Comparison of the average number of eggs secreted by Kato-Katz and qPCR between different groups in weeks 16-20 after the infection
Time frame: 20 weeks
Plan to share: No
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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