CompletedPhase 2

Efficacy of Na-GST-1/Alhydrogel Hookworm Vaccine Assessed by Controlled Challenge Infection

United States39 participantsStarted 2018-03-01

Plain-language summary

This study evaluates the efficacy, safety and immunogenicity of different formulations of the Na-GST-1 hookworm vaccine using a controlled human hookworm infection model in healthy, hookworm-naive adults.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Males and non-pregnant females between 18 and 45 years, inclusive.
. Good general health as determined by means of the screening procedures1.
. Available for the duration of individual subject study participation (14 months).
. Willingness to participate in the study as evidenced by signing the informed consent document.
. Able to understand and comply with planned study procedures.

Exclusion criteria

. Pregnancy as determined by a positive urine human choriogonadotropin (hCG) test (if female).
. Subject unwilling to use effective contraception for a minimum of 30 days prior to vaccination and up until documentation of clearance of hookworm infection post-CHHI (if female and not surgically sterile, abstinent from intercourse with a male partner, in a monogamous relationship with a vasectomized partner, at least 2 years post-menopausal, or determined otherwise by medical evaluation to be sterile).
. Currently lactating and breast-feeding or plans to breastfeed at any given time from the first study vaccination until clearance of hookworm infection post-CHHI (if female).
. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, gastrointestinal, diabetes, or renal disease by history, physical examination, and/or laboratory studies.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Detectable Hookworm Infection

Timeframe: On Study Days 175, 182, 189, 203, 217, 231, 245, 259, 273, and 280.

Incidence of Serious Adverse Events

Timeframe: Beginning on Day 0 when the first dose is received and ending on Day 380 (final study visit).

Incidence of Solicited Injection Site and Systemic Reactogenicity

Timeframe: Dose 1: Days 0, 3, 7, 14; Dose 2: Days 56, 59, 63, 70; Dose 3: Days 112, 115, 119, 126

Incidence of Solicited Adverse Events

Timeframe: Day of CHHI, Day 140, and study days: 143, 147, 154, 175, 182, 189, 196, 203, 210, 217, 224, 231, 238, 245, 252, 259, 266, 273, 280. Day 280 is the day of anti-worm treatment.

Incidence of Clinical Safety Laboratory Abnormalities

Timeframe: Study days: 0, 14, 56, 70, 112, 126, 140, 154, 175, 189, 203, 217, 231, 259, 280.

Incidence of Unsolicited Adverse Events

Timeframe: From Dose 1 on Day 0 until anti-worm treatment on Day 280.

Trial details

NCT IDNCT03172975

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Results submitted2025-09-08

View on ClinicalTrials.gov More Hookworm Infections trials