Scientists infect volunteers with hookworms to test future vaccine
NCT ID NCT01940757
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study aims to find the safest and most consistent dose of hookworm larvae to use in future vaccine trials. Healthy adults aged 18 to 45 will receive different numbers of hookworm larvae through the skin. Researchers will monitor side effects and measure hookworm eggs in stool to determine the best dose for testing a hookworm vaccine.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Infectious hookworm larvae (Necator americanus)
- What this could lead to
- If successful, this study could help create a reliable model to test hookworm vaccines, potentially leading to a way to prevent hookworm infection.
- What could go wrong
- This is an early Phase 1 study with only 35 participants, so results may not apply broadly. The hookworm infection itself can cause temporary side effects like rash or stomach issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2015
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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). * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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George Washington University Medical Faculty Associates
RECRUITINGWashington D.C., District of Columbia, 20037, United States
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