Hookworm Vaccine for Hookworm Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a potential vaccine for hookworm infections by determining if it can prevent the worms from feeding on blood. Participants will receive varying doses of Necator americanus hookworm larvae to identify the safest and most effective amount for causing a consistent infection. Healthy adults who have never had a hookworm infection and have not lived in areas where hookworms are common may qualify for this study. The goal is to assess whether this vaccine can help prevent hookworm infection in the future. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have used corticosteroids (except topical or nasal) or immunosuppressive drugs within 30 days before the study or plan to use them during the study.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that Necator americanus, the hookworm used in this trial, commonly causes hookworm infections worldwide, particularly in rural areas with poverty. Although widespread, these infections are usually not life-threatening.
Previous studies have found that short-term exposure to these larvae can cause a skin reaction and an increase in certain white blood cells called eosinophils. These effects indicate an immune response but typically do not lead to serious health problems. The goal is to find a dose that is both safe and effective for study purposes.
As this trial is in an early stage, the main aim is to determine if the doses are safe and well-tolerated. While this specific trial may not yet have extensive safety data, researchers conduct studies with Necator americanus using careful risk management.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for hookworm infection, which usually involve antiparasitic drugs like albendazole or mebendazole, this new approach uses live Necator americanus hookworm larvae. Researchers are excited because these larvae may help the body build immunity against hookworms in a more natural and potentially longer-lasting way. The treatment involves administering the larvae via a simple absorbent pad, which is a novel and less invasive delivery method compared to traditional oral medications. This method could offer a new way to prevent hookworm infection rather than just treating it after the fact.
What evidence suggests that this trial's treatments could be effective for hookworm infection?
This trial will evaluate different doses of Necator americanus hookworm larvae as a potential vaccine for hookworm infection. Research has shown that short-term exposure to Necator americanus hookworm larvae can help protect the body. Studies have found that this type of hookworm infection is generally safe, with no deaths reported among over 500 participants in similar studies. Hookworm infection is a major health problem, affecting about 500 million people worldwide, mostly in low-income countries. It mainly causes issues like anemia (when the body doesn't have enough healthy red blood cells) and malnutrition. The goal of using hookworm larvae in a vaccine is to lessen these problems by targeting the worms' blood-feeding habits. Early research suggests this method is promising.56789
Who Is on the Research Team?
David J Diemert, MD
Principal Investigator
George Washington University
Are You a Good Fit for This Trial?
Healthy adults aged 18-45 who have never had a hookworm infection can join this trial. They must be in good health, not pregnant or breastfeeding, willing to use contraception if applicable, and available for the next 6 months. People with significant health issues like heart or liver disease, immunodeficiency, certain blood conditions, severe allergies or asthma cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single application of Necator americanus Larval Inoculum on Study Day 0, with doses of 25, 50, or 75 larvae depending on cohort
Observation and Safety Assessment
Participants are monitored for safety and tolerability, with capsule endoscopy performed between Study Day 70 and 77 for up to 5 volunteers per cohort
Anthelmintic Treatment
Participants receive a 3-dose treatment of albendazole (400 mg per dose) for clearance of experimental infection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Necator americanus Hookworm Larvae
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor