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 ran this malady ahead of malaria. Current control strategies have been geared toward repeated treatment 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 lowered 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 through cGMP manufacture for future human clinical trials, ultimately resulting in an approved vaccine.

Public Health Relevance

A low-cost, effective vaccine for schistosomiasis would greatly aid in the fight against this debilitating disease. By producing a new candidate vaccine compliant with federal regulations for human clinical trials we intend to progress toward a commercial product leading to an improvement in global health.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44AI103983-03A1
Application #
9043643
Study Section
Special Emphasis Panel (ZRG1-IMM-R (12))
Program Officer
MO, Annie X Y
Project Start
2013-01-01
Project End
2018-12-31
Budget Start
2016-01-01
Budget End
2016-12-31
Support Year
3
Fiscal Year
2016
Total Cost
$1,159,786
Indirect Cost
Name
Pai Life Sciences, Inc.
Department
Type
DUNS #
148051621
City
Seattle
State
WA
Country
United States
Zip Code
98102
Molehin, Adebayo J; Sennoune, Souad R; Zhang, Weidong et al. (2017) Cross-species prophylactic efficacy of Sm-p80-based vaccine and intracellular localization of Sm-p80/Sm-p80 ortholog proteins during development in Schistosoma mansoni, Schistosoma japonicum, and Schistosoma haematobium. Parasitol Res 116:3175-3188
Siddiqui, Afzal A; Siddiqui, Sabrina Z (2017) Sm-p80-Based Schistosomiasis Vaccine: Preparation for Human Clinical Trials. Trends Parasitol 33:194-201
Molehin, Adebayo J; Rojo, Juan U; Siddiqui, Sabrina Z et al. (2016) Development of a schistosomiasis vaccine. Expert Rev Vaccines 15:619-27
Gray, S A; Coler, R N; Carter, D et al. (2016) Translational Activities to Enable NTD Vaccines. Prog Mol Biol Transl Sci 142:291-315