An experimental hookworm infection model is being developed to provide early proof-of-concept that a hookworm vaccine targeting the blood-feeding pathway of adult hookworms is feasible and efficacious. The proposed model consists of vaccinating healthy, hookworm-naïve adults with a candidate hookworm vaccine, followed by challenging them with the investigational product, Necator americanus Larval Inoculum to assess the effect of vaccination on infection. The first proposed study will be a feasibility study that will consist of administering different doses of the Necator americanus Larval Inoculum to healthy adult volunteers to determine the optimal dose (i.e., number of infectious larvae) that is safe, well-tolerated and results in consistent infection.
Males or females between 18 and 45 years, inclusive.
Good general health as determined by means of the screening procedure.
Available for the duration of the trial (6 months).
Willingness to participate in the study as evidenced by signing the informed consent document.
Pregnancy as determined by a positive urine human choriogonadotropin (hCG) (if female).
Participant unwilling to use reliable contraception methods while participating in the study (if female and not surgically sterile, abstinent or at least 2 years post-menopausal).
Currently lactating and breast-feeding (if female).
Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies.
Parallel
Necator americanus Hookworm Larvae
Biological/VaccineInfectious larvae of the human hookworm Necator americanus
Study product-related adverse events
Frequency of study product-related adverse events, graded by severity, for different doses of N. americanus Larval Inoculum.
Fecal egg counts
To determine the dose of N. americanus Larval Inoculum that generates the highest fecal egg counts, measured by fecal microscopy.
Number of adult hookworms in feces post-treatment
To compare the N. americanus Larval Inoculum dose received with the number of adult worms present in the gut, as determined by capsule endoscopy.
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