A Phase I/II Study of the Safety, Immunogenicity, and Efficacy of Sm-TSP-2/Alhydrogel® With or Without AP 10-701 for Intestinal Schistosomiasis in Healthy Ugandan Adults

H-45791

The study will recruit up to 290 healthy adult males and non-pregnant females into a two-part clinical trial of a vaccine to protect against schistosomiasis caused by infection with S. mansoni. Two formulations of the Sm-TSP-2 vaccine will be tested: one using Alhydrogel® only, and one using Alhydrogel® plus AP 10-701, each at 3 different doses of antigen: 10mcg, 30mcg, and 100mcg. The first part of the study will be a Phase I dose-escalation safety and immunogenicity study followed by a Phase IIb trial in which a larger number of adults will be enrolled to assess the impact of the vaccine on infection with S. mansoni. The impact of the vaccine on infection with S. haematobium will also be assessed although this will be exploratory given that potential cross-protection against this species is only hypothetical at this point.

2019-10-07

2024-09-01

2024-09-01

Active (not recruiting)

Early phase I

290

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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2024-01-05