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Parasitic Vaccine

Na-GST-1/Alhydrogel Hookworm Vaccine for Hookworm Infection

Phase 2

Waitlist Available

Led By David 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 and non-pregnant females between 18 and 45 years, inclusive

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 and 14 days following each vaccination; on day of chhi; and then 7 and 14 days, and 5, 7, 13, and 20 weeks post-chhi

Awards & highlights

Study Summary

This trial looks at how well different formulations of a hookworm vaccine work in people who have never had hookworm, in terms of safety, how well it works, and how long the immunity lasts.

Who is the study for?

Adults aged 18-45 in good health, never had hookworms, and can commit to a 14-month study. They must not have severe allergies or be pregnant/lactating. Participants should not use drugs/alcohol problematically, have significant medical conditions, or take immunosuppressants.Check my eligibility

What is being tested?

The trial is testing the effectiveness of different Na-GST-1/Alhydrogel hookworm vaccine formulations against a controlled human hookworm infection. It includes a placebo group and examines safety and immune response.See study design

What are the potential side effects?

Possible side effects may include reactions at the injection site, mild flu-like symptoms, gastrointestinal discomfort, or allergic responses due to vaccine components.

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 and not pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 and 14 days following each vaccination; on day of chhi; and then 7 and 14 days, and 5, 7, 13, and 20 weeks post-chhi

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 and 14 days following each vaccination; on day of chhi; and then 7 and 14 days, and 5, 7, 13, and 20 weeks post-chhi

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 and 14 days following each vaccination; on day of chhi; and then 7 and 14 days, and 5, 7, 13, and 20 weeks post-chhi for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Detectable hookworm infection

Incidence of Adverse Events of Special Interest

Incidence of Serious Adverse Events

+5 more

Secondary outcome measures

Anti-Na-GST-1 IgG antibody affinity

Anti-Na-GST-1 IgG antibody response

Fecal egg counts

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Na-GST-1/Alhydrogel + GLA-AFExperimental Treatment3 Interventions

100 µg ˆNaˆ-GST-1/Alhydrogel co-administered with 5 µg GLA-AF delivered intramuscularly in the deltoid on study days 0, 56 and 112 followed by controlled human hookworm infection with 50 infectious Necator americanus larvae on study day 140.

Group II: Na-GST-1/Alhydrogel + CPG 10104Experimental Treatment3 Interventions

100 µg ˆNaˆ-GST-1/Alhydrogel co-administered with 500 µg CPG 10104 delivered intramuscularly in the deltoid on study days 0, 56 and 112 followed by controlled human hookworm infection with 50 infectious Necator americanus larvae on study day 140.

Group III: Na-GST-1/AlhydrogelExperimental Treatment3 Interventions

100 µg ˆNaˆ-GST-1/Alhydrogel administered intramuscularly in the deltoid on study days 0, 56 and 112 followed by controlled human hookworm infection with 50 infectious Necator americanus larvae on study day 140.

Group IV: Saline PlaceboPlacebo Group3 Interventions

Sterile saline placebo delivered intramuscularly in the deltoid on study days 0, 56 and 112 followed by controlled human hookworm infection with 50 infectious Necator americanus larvae on study day 140.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Na-GST-1/Alhydrogel

2017

Completed Phase 1

~60

Albendazole

2008

Completed Phase 4

~12050