SBIR-STTR Award

A Vaccine for Schistosomiasis, "Schistoshield"
Award last edited on: 5/19/2023

Sponsored Program
SBIR
Awarding Agency
NIH : NIAID
Total Award Amount
$6,148,156
Award Phase
2
Solicitation Topic Code
855
Principal Investigator
Darrick A Carter

Company Information

PAI Life Sciences Inc (AKA: Protein AI~Protein Advances Inc)

1616 Eastlake Avenue East Suite 550
Seattle, WA 98102
   (206) 623-0331
   info@pailifesciences.com
   www.pailifesciences.com
Location: Single
Congr. District: 07
County: King

Phase I

Contract Number: 1R43AI103983-01
Start Date: 1/1/2013    Completed: 12/31/2014
Phase I year
2013
Phase I Amount
$300,000
Schistosomiasis is a major neglected tropical disease of public health concern to a billion people with 200 million currently infected and 779 million at risk to acquire the infection, the majority of these in Africa. The disease has a high impact on affected people's lives with disability adjusted life years at 70 million years which rank this malady ahead of malaria. Current control strategies have been geared toward repeated with a drug discovered in the 1970s and standards for monitoring administration and progress have been inconsistent and inadequate. Reliance on the drug therapy approach alone is a poor strategy since this approach has had little impact on the reduction of disease transmission and there is always the inherent threat of drug resistance being developed by the parasite. A prophylactic schistosomiasis vaccine that provides at least 50% protection would play an important role in dramatically reducing the impact of this disease. Vaccine-generated immune responses could lead to reduced worm burdens and lower egg production and ultimately result in lower transmission. This application is an extension of our systematic and methodical approach towards developing a vaccine for schistosomiasis. Over the last twenty years, we have applied this strategy towards developing Sm-p80 into a viable vaccine candidate. At present, to our knowledge, Sm- p80 is the sole schistosome vaccine candidate that has been tested for prevention, interruption of transmission and in therapy. Our candidate vaccine has three protective effects: worm reduction, egg reduction, and protection against acute disease. Funding this application will help our continuing efforts to develop Sm-p80 towards manufacture for future human clinical trials, ultimately resulting in an approved vaccine.

Public Health Relevance Statement:


Public Health Relevance:
A low-cost, effective vaccine for schistosomiasis would greatly aid in the fight against this debilitating disease. By discovering and validating a new candidate vaccine we intend to progress toward a commercial product leading to an improvement in global health.

Project Terms:
Acute; Acute Disease; Adjuvant; Adult; Affect; Africa; Agonist; Antigens; base; Biochemical; Biological; Biological Assay; Budgets; Characteristics; Clinical; Clinical Trials; cost; cost effective; Country; Coupled; Cyclic GMP; Data; Development; disability-adjusted life years; Disease; disease transmission; DNA; Drug Formulations; Drug resistance; egg; Emulsions; Experimental Animal Model; Fermentation; fight against; Funding; Future; global health; Goals; Human; Immune response; Infection; Inferior; Interruption; Lead; Lipids; Malaria; Mediating; Methodology; Modeling; Monitor; Morbidity - disease rate; Mus; nanoDroplet; neglect; Papio; Parasites; Pathology; Pharmaceutical Preparations; Pharmacotherapy; Phase; Play; Praziquantel; pre-clinical; Preparation; Prevention; Process; Production; prophylactic; protective effect; Proteins; public health medicine (field); public health relevance; Recombinant Proteins; Records; Reliance; Research; Risk; Role; Schistosoma; Schistosomiasis; Seeds; Sm antigen; Small Business Innovation Research Grant; Structure; Techniques; Testing; Therapeutic Effect; toll-like receptor 4; transmission process; Treatment Efficacy; Tropical Disease; Vaccination; vaccine candidate; vaccine development; Vaccines; Work

Phase II

Contract Number: 5R43AI103983-02
Start Date: 1/1/2013    Completed: 12/31/2015
Phase II year
2014
(last award dollars: 2021)
Phase II Amount
$5,848,156

Schistosomiasis is a major neglected tropical disease of public health concern to a billion people with 200 million currently infected and 779 million atrisk to acquire the infection, the majority of these in Africa. The disease has a high impact on affected people's lives with disability adjusted life years at 70 million years which rank this malady ahead of malaria. Current control strategies have been geared toward repeated with a drug discovered in the 1970s and standards for monitoring administration and progress have been inconsistent and inadequate. Reliance on the drug therapy approach alone is a poor strategy since this approach has had little impact on the reduction of disease transmission and there is always the inherent threat of drug resistance being developed by the parasite. A prophylactic schistosomiasis vaccine that provides at least 50% protection would play an important role in dramatically reducing the impact of this disease. Vaccine-generated immune responses could lead to reduced worm burdens and lower egg production and ultimately result in lower transmission. This application is an extension of our systematic and methodical approach towards developing a vaccine for schistosomiasis. Over the last twenty years, we have applied this strategy towards developing Sm-p80 into a viable vaccine candidate. At present, to our knowledge, Sm- p80 is the sole schistosome vaccine candidate that has been tested for prevention, interruption of transmission and in therapy. Our candidate vaccine has three protective effects: worm reduction, egg reduction, and protection against acute disease. Funding this application will help our continuing efforts to develop Sm-p80 towards manufacture for future human clinical trials, ultimately resulting in an approved vaccine.

Thesaurus Terms:
Acute;Acute Disease;Adjuvant;Adult;Affect;Africa;Agonist;Antigens;Base;Biochemical;Biological;Biological Assay;Budgets;Characteristics;Clinical;Clinical Trials;Cost;Cost Effective;Country;Coupled;Cyclic Gmp;Data;Development;Disability-Adjusted Life Years;Disease;Disease Transmission;Dna;Drug Formulations;Drug Resistance;Egg;Emulsions;Experimental Animal Model;Fermentation;Fight Against;Funding;Future;Global Health;Goals;Human;Immune Response;Infection;Inferior;Interruption;Lead;Lipids;Malaria;Mediating;Methodology;Modeling;Monitor;Morbidity - Disease Rate;Mus;Nanodroplet;Neglect;Papio;Parasites;Pathology;Pharmaceutical Preparations;Pharmacotherapy;Phase;Play;Praziquantel;Pre-Clinical;Preparation;Prevention;Process;Production;Prophylactic;Protective Effect;Proteins;Public Health Medicine (Field);Public Health Relevance;Recombinant Proteins;Records;Reliance;Research;Risk;Role;Schistosoma;Schistosomiasis;Seeds;Sm Antigen;Small Business Innovation Research Grant;Structure;Techniques;Testing;Therapeutic Effect;Toll-Like Receptor 4;Transmission Process;Treatment Efficacy;Tropical Disease;Vaccination;Vaccine Candidate;Vaccine Development;Vaccines;Work;