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New vaccine trial aims to stop parasitic worm infection in its tracks

NCT ID NCT03910972

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new vaccine (Sm-TSP-2) to protect against intestinal schistosomiasis, a parasitic worm infection common in parts of Africa. Healthy adults in Uganda received different doses of the vaccine, with or without an immune booster, to check safety and how well it triggers protection. The goal is to see if the vaccine can reduce or prevent infection.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

290 people

The number who actually took part.

Started

Oct 2019

Finished

Nov 2024

Lead sponsor

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

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: 1. Provide written informed consent prior to any study procedures. 2. Able to understand and comply with planned study procedures and be available for all study visits. 3. Male or non-pregnant female aged 18 to 45, inclusive at the time of enrollment. 4. Are in good health, as determined by vital signs (oral temperature, pulse, and blood pressure), medical history, and brief physical examination at screening. 5. Vital signs (oral temperature, pulse, and blood pressure) are all within normal protocol-defined ranges. 6. Laboratory tests (alanine aminotransferase \[ALT\], creatinine, white blood cell count (WBC), hemoglobin, and platelets) are all within protocol-defined reference ranges. 7. Urinalysis with no greater than trace protein and negative for glucose. 8. Female subjects of childbearing potential must agree to practice highly effective contraception for a minimum of 30 days prior to first vaccination and for 30 days after last vaccination. 9. Female subjects of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccination. 10. Able to correctly answer all questions on the informed consent comprehension questionnaire. Exclusion Criteria: 1. Has the intention to become pregnant within 5 months after enrollment in this study. 2. Female subjects who are breastfeeding or plan to breastfeed at any given time from the first study vaccination until 30 days after their last study vaccination. 3. Has an acute illness, including a documented oral temperature of 38.0°C or greater, within 72 hours prior to vaccination. 4. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies. 5. Is immunosuppressed as a result of an underlying illness or treatment. 6. Using or intends to continue using oral or parenteral steroids, high-dose inhaled steroids (\>800 μg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs. 7. Positive test for HIV infection. 8. Volunteer has had a history of alcohol or illicit drug abuse during the past 23 months. 9. Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 90 days prior to study vaccination. 10. History of a severe allergic reaction or anaphylaxis to known components of the study vaccines. 11. Has an acute or chronic medical condition that, in the opinion of the investigator, would render participation in this study unsafe or would interfere with the evaluation of responses. 12. History of splenectomy. 13. Is participating or plans to participate in another clinical trial with an interventional agent during the duration of the study. 14. Received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to the first study vaccination. 15. Planned receipt of any vaccine from the first study vaccination through 28 days after the last study vaccination. 16. Has any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations. 17. Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. 18. Anti-Sm-TSP-2 IgE antibody level above ELISA reactivity threshold. Part A Only: 19. Positive hepatitis B surface antigen (HBsAg). 20. Positive confirmatory test for hepatitis C virus (HCV) infection. Part B Only: 21. Negative for Schistosoma mansoni eggs, as assessed by the Kato Katz fecal thick smear during screening.

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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.

Contacts and locations

Locations

  • Makerere University Walter Reed Project

    Kampala, Uganda

More trials for these conditions

Other studies related to the condition(s) this trial covers.