Baylor College of Medicine
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.
Open-label, dose-escalation clinical study in healthy, hookworm-naïve adults: * Study site: George Washington Medical Faculty Associates, Washington, DC * Number of participants: up to 35 in 3 cohorts In Cohort 1, ten (10) volunteers will receive an inoculum of 25 infectious Necator americanus larvae. In Cohort 2, ten (10) volunteers will receive an inoculum of 50 infectious Necator americanus larvae. In the optional Cohort 3, fifteen (15) volunteers will receive an inoculum of 75 infectious Necator americanus larvae. The cohorts will be enrolled in a staggered fashion with safety data asse…
Inclusion Criteria: * 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. Exclusion Criteria: * 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). * Curr…
Infectious larvae of the human hookworm Necator americanus
Arctuva estimate
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