SchistoShield (Sm-p80/GLA-SE) / International Vaccine Institute - LARVOL DELTA

Antibody-mediated functional responses induced by the SchistoShield® schistosomiasis vaccine in disease-naïve and endemic human populations. (PubMed, Vaccine) - "Praziquantel (PZQ) remains the principal standard treatment for schistosomiasis, but concerns about its reduced effectiveness against larval stages, reinfections, and emerging drug resistance reinforces the urgent need for a vaccine. Passive transfer of human total IgG from vaccinated individuals in mice revealed notable reductions in worm burden, egg counts, and egg-hatching ability compared to groups given pre-vaccination sera across all trials. Overall, these findings support that SchistoShield® induces generation of functional antibodies that may play a crucial role in antibody-mediated protection against schistosomiasis."

Journal • Alzheimer's Disease • Cognitive Disorders • Hematological Disorders • Infectious Disease

Schistosomiasis vaccine SchistoShield® induces functional immune memory responses in US and African populations. (PubMed, NPJ Vaccines) - "Consistent with T-helper responses that promote humoral immunity, Sm-p80 antigen-specific antibody-secreting plasmablasts were detected in vaccinated volunteers who were tracked longitudinally. Taken together, the SchistoShield® vaccine induced robust cell-mediated effector and memory responses, hallmarks of a potentially efficacious vaccine against schistosome/helminth parasites."

Journal • Infectious Disease • CD4 • GZMB • IFNG • IL17A • IL9 • TNFA

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar (clinicaltrials.gov) - P1 | N=120 | Completed | Sponsor: International Vaccine Institute | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

Safety and immunogenicity of the Sm-p80 GLA-SE schistosomiasis vaccine. (PubMed, NPJ Vaccines) - P1 | "The vaccine formulations, given as a three dose intramuscular series, were well tolerated and adjuvanted formulations induced robust IgG ELISA responses against the Sm-p80 antigen. The vaccine has been advanced to a Phase 1b trial among adults in endemic areas of Africa.Clinicaltrials.gov registration: NCT05292391 https://Clinicaltrials.gov/study/NCT05292391 ."

Journal • Infectious Disease

Characterization and development of Schistosoma haematobium calpain-based vaccines: Next generation vaccines for urogenital schistosomiasis (ASTMH 2025) - "Based on our previous work with S. mansoni vaccine, Sm-p80 formulated in GLA-SE (SchistoShield®), now in clinical trials, we hypothesize that the S. haematobium p80 calpain ortholog would provide protection against UGS...In an ongoing efficacy study, CaTaCo-HemTM-based vaccines induced significantly higher specific IgG than Sh-p80 in immunized hamsters suggesting that CaTaCo-HemTM-based vaccine formulations could potentially be more efficacious in protection against urogenital schistosomiasis. Data on efficacy endpoint readout are currently being collected, but we believe that the CaTaCo-HemTM-based vaccine formulations would provide better protection against UGS than Sh-p80 since resistance against schistosomiasis is associated with specific antibody production."

Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Infertility • Sexual Disorders • Solid Tumor • TLR4

Potential biomarker and composite efficacy readout for human clinical trials of schistosomiasis vaccine in Africa. (PubMed, Sci Rep) - "Sm-p80-specific antibodies produced by immunized non-human primates and humans induced statistically significant larval schistosomula killing ex vivo. This reproducible functional assay has the potential to serve as one of the biomarkers for the effectiveness of the SchistoShield vaccine in human trials in Africa."

Biomarker • Journal • Infectious Disease

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: International Vaccine Institute | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ May 2025 | Trial primary completion date: Dec 2024 ➔ May 2025

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease

A functional enzymatic assay as potential readout for a clinical trial of a schistosomiasis vaccine. (PubMed, NPJ Vaccines) - "Statistically significant inhibition of the B7 activity was observed by Sm-p80-specific antibodies produced by immunized mice, non-human primates and humans. This quantitative serological assay could be of value in assessing the effectiveness of the SchistoShield® vaccine in human trials in Africa."

Journal • Infectious Disease

An assessment of a GMP schistosomiasis vaccine (SchistoShield®). (PubMed, Front Trop Dis) - "In addition, an effort was made to analyze and compare the Quratis-made lot of Sm-p80, referred to as QTP-105, to the cGMP lot of Sm-p80 which is in use in human trials in the USA and Africa, referred to as Sm-p80 DP (made in USA). We show that QTP-105 demonstrates excellent potency, purity, identity, and endotoxin levels compared to our Phase 1 Sm-p80 DP and is suitable for use in Phase 2 studies and beyond."

Journal • Infectious Disease • TLR4

Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults (clinicaltrials.gov) - P1 | N=45 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: International Vaccine Institute | Not yet recruiting ➔ Recruiting | Phase classification: P1b ➔ P1

Enrollment open • Phase classification • Infectious Disease