Sm-TSP-2/Alhydrogel vaccine / Baylor College of Medicine, National Institutes of Health - LARVOL DELTA

Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults (clinicaltrials.gov) - P1/2 | N=290 | Completed | Sponsor: Baylor College of Medicine | Trial completion date: Sep 2025 ➔ Nov 2024 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date • Infectious Disease

A Phase II Proof-of-Efficacy Trial of Sm-TSP-2/Alhydrogel for Intestinal Schistosomiasis in Healthy Ugandan Adults (ASTMH 2025) - "Two hundred participants were enrolled, treated with 60 mg/kg praziquantel at baseline, and randomized at a 1:1 ratio to receive 100µg Sm-TSP-2/Al/AP 10-701 or Hepatitis B vaccine (HBV) as a comparator. Participants were followed for 18 months after final vaccination with fecal microscopic exams using the Kato-Katz technique performed to quantify S. mansoni eggs at 12- and 18-months. Final unblinded efficacy results will be presented."

Clinical • P2 data • Fatigue • Hepatitis B • Hepatology • Infectious Disease • Inflammation • TLR4

Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults (clinicaltrials.gov) - P1/2 | N=290 | Active, not recruiting | Sponsor: Baylor College of Medicine | Trial completion date: Sep 2024 ➔ Sep 2025

Trial completion date • Infectious Disease

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 (ASTMH 2024) - "The highest IgG antibody response, as determined by ELISA, was detected among participants who received 100mcg Sm -TSP-2/Al with AP 10-701, which was thus chosen as the optimal dose for the Phase II stage of the study that is currently underway. Addition of AP 10-701 to Sm -TSP-2/Al improved IgG responses but did not compromise safety."

Clinical • P1/2 data • Fatigue • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pain • TLR4

A randomized, controlled Phase 1b trial of the Sm-TSP-2 Vaccine for intestinal schistosomiasis in healthy Brazilian adults living in an endemic area. (PubMed, PLoS Negl Trop Dis) - P1 | "Vaccination of adults with Sm-TSP-2/Alhydrogel in an area of ongoing S. mansoni transmission was safe, minimally reactogenic, and elicited significant IgG and IgG subclass responses against the vaccine antigen. These promising results have led to initiation of a Phase 2 clinical trial of this vaccine in an endemic region of Uganda."

Journal • P1 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pain • TLR4 • TSPAN2

Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults (clinicaltrials.gov) - P1/2 | N=290 | Active, not recruiting | Sponsor: Baylor College of Medicine | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2025 ➔ Sep 2024

Enrollment closed • Trial completion date • Infectious Disease

Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults (clinicaltrials.gov) - P1/2 | N=290 | Recruiting | Sponsor: Baylor College of Medicine | Trial completion date: May 2025 ➔ Nov 2025 | Trial primary completion date: May 2024 ➔ Nov 2024

Trial completion date • Trial primary completion date • Infectious Disease