RECRUITING

Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae

Conditions

Hookworm Infection Necator americanus Experimental challenge infection

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Experimental Infection Study of Dermally-applied Infectious Necator Americanus Hookworm Larvae in Hookworm-naïve Adults

Quick Facts

Study Start:2015-01

Study Completion:2025-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01940757

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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. * Known or suspected immunodeficiency. * Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than 1.25-times the upper reference limit). * Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit, or more than trace protein or blood on urine dipstick testing). * Laboratory evidence of hematologic disease (hemoglobin \<11.5 g/dl \[females\] or \<12.5 g/dl \[males\]; absolute leukocyte count \<3.6 or \>10.7 x 103/mm3; absolute neutrophil count \[ANC\] \<1.7 x 103/mm3; absolute lymphocyte count \<0.7 x 103/mm3; or platelet count \<140 x 103/mm3). * History of iron deficiency anemia. * History of hypoalbuminemia. * Laboratory evidence of a coagulopathy (PTT or PT INR greater than 1.1-times the upper reference limit). * Serum glucose (random) greater than 1.2-times the upper reference limit. * Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol. * Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months. * History of a severe allergic reaction or anaphylaxis. * Severe asthma as defined by the need for daily use of inhalers or emergency clinic visit or hospitalization within 6 months of the volunteer's expected Day 0 of the study. * Positive ELISA for hepatitis B surface antigen (HBsAg). * Positive confirmatory test for HIV infection. * Positive confirmatory test for hepatitis C virus (HCV) infection. * Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of the volunteer's expected Day 0 of this study or planned use during the study. * Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to the volunteer's expected Day 0 of the study. * Receipt of blood products within the past 6 months. * Known allergy to amphotericin B or gentamicin. * History of previous infection with hookworm or residence for more than 6 months in a hookworm-endemic area.

Inclusion Criteria

Exclusion 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.

* 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.
* Known or suspected immunodeficiency.
* Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than 1.25-times the upper reference limit).
* Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit, or more than trace protein or blood on urine dipstick testing).
* Laboratory evidence of hematologic disease (hemoglobin \<11.5 g/dl \[females\] or \<12.5 g/dl \[males\]; absolute leukocyte count \<3.6 or \>10.7 x 103/mm3; absolute neutrophil count \[ANC\] \<1.7 x 103/mm3; absolute lymphocyte count \<0.7 x 103/mm3; or platelet count \<140 x 103/mm3).
* History of iron deficiency anemia.
* History of hypoalbuminemia.
* Laboratory evidence of a coagulopathy (PTT or PT INR greater than 1.1-times the upper reference limit).
* Serum glucose (random) greater than 1.2-times the upper reference limit.
* Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
* Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
* History of a severe allergic reaction or anaphylaxis.
* Severe asthma as defined by the need for daily use of inhalers or emergency clinic visit or hospitalization within 6 months of the volunteer's expected Day 0 of the study.
* Positive ELISA for hepatitis B surface antigen (HBsAg).
* Positive confirmatory test for HIV infection.
* Positive confirmatory test for hepatitis C virus (HCV) infection.
* Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of the volunteer's expected Day 0 of this study or planned use during the study.
* Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to the volunteer's expected Day 0 of the study.
* Receipt of blood products within the past 6 months.
* Known allergy to amphotericin B or gentamicin.
* History of previous infection with hookworm or residence for more than 6 months in a hookworm-endemic area.

Contacts and Locations

Study Contact

Study Coordinator

CONTACT

(202) 994-1599

gwvru@gwu.edu

Principal Investigator

David J Diemert, MD

PRINCIPAL_INVESTIGATOR

George Washington University

Study Locations (Sites)

George Washington University Medical Faculty Associates

Washington, District of Columbia, 20037

United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

David J Diemert, MD, PRINCIPAL_INVESTIGATOR, George Washington University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-01

Study Completion Date2025-02

Study Record Updates

Study Start Date2015-01

Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

Necator americanus
Hookworm Infection
Experimental challenge infection

Additional Relevant MeSH Terms

Hookworm Infection