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Virus Therapy

Hookworm Vaccine for Hookworm Infection

Phase 1
Recruiting
Led By David J Diemert, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females between 18 and 45 years, inclusive
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months after dosing
Awards & highlights

Study Summary

This trial is testing whether a hookworm vaccine is safe and effective. The study will infect participants with hookworms, then vaccinate them to see if the vaccine prevents infection.

Who is the study for?
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.Check my eligibility
What is being tested?
The study is testing whether a vaccine against hookworms is effective by giving healthy volunteers the vaccine and then exposing them to Necator americanus larvae. The goal is to find a safe dose of larvae that consistently causes infection without serious side effects.See study design
What are the potential side effects?
Potential side effects from exposure to hookworm larvae include skin irritation at the site of application, gastrointestinal symptoms (like stomach pain), fatigue, coughing and potential anemia due to blood loss caused by the worms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 45 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Study product-related adverse events
Secondary outcome measures
Fecal egg counts
Number of adult hookworms in feces post-treatment

Trial Design

3Treatment groups
Experimental Treatment
Group I: 75 Necator americanus Hookworm LarvaeExperimental Treatment1 Intervention
Group II: 50 Necator americanus Hookworm LarvaeExperimental Treatment1 Intervention
Group III: 25 Necator americanus Hookworm LarvaeExperimental Treatment1 Intervention

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
999 Previous Clinical Trials
6,001,869 Total Patients Enrolled
David J Diemert, MDPrincipal InvestigatorGeorge Washington University
2 Previous Clinical Trials
49 Total Patients Enrolled

Media Library

Necator americanus Hookworm Larvae (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01940757 — Phase 1
Hookworm Infection Research Study Groups: 25 Necator americanus Hookworm Larvae, 50 Necator americanus Hookworm Larvae, 75 Necator americanus Hookworm Larvae
Hookworm Infection Clinical Trial 2023: Necator americanus Hookworm Larvae Highlights & Side Effects. Trial Name: NCT01940757 — Phase 1
Necator americanus Hookworm Larvae (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01940757 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current scope of recruitment for this clinical trial?

"Affirmative. The information on clinicaltrials.gov implies that this medical trial is actively seeking to recruit participants. It was initially posted on 1/1/2015 and the most recent update occurred on 8/2/2022, with a total of 30 patients required for participation at one single site."

Answered by AI

Are there still opportunities to participate in this investigation?

"Affirmative. Clinicaltrials.gov demonstrates that this clinical trial, which was originally posted on January 1st 2015, is actively recruiting participants. Approximately 30 patients must be recruited from a singular medical centre."

Answered by AI

Is there a potential for harm when exposed to Necator americanus Hookworm Larvae?

"Our team at Power assigned Necator americanus Hookworm Larvae a score of 1 on the safety scale, as this is an early-phase trial with limited evidence supporting its use."

Answered by AI

Does this trial include participants who are 35 years or older?

"Participants eligible for this trial must be between 18 and 45 years old. For those under the age of consent, there are 199 studies available, whereas older individuals can choose from 607 trials."

Answered by AI

Who can partake in this trial and its associated benefits?

"This trial is open for enrolment of 30 individuals with bunostomiasis between the age limits of 18 to 45. The mandatory criteria are: male or female and aged between 18-45 years old, able to participate throughout the entire 6 months duration of this experiment."

Answered by AI
~1 spots leftby Sep 2024