Antigen and adjuvant selection for a vaccine against urogenital schistosomiasis, hematoshield

Ended Project Grant Awarded Last action

Award ID
R41AI181069
Recipient
Awarding agency
Obligated
$295,386

Award facts

Assistance listing
93.855 Allergy and Infectious Diseases Research
Completion date
Originally
Place of performance
Washington, USA

Award details come from USAspending.gov.

Description

Abstract
Schistosomiasis, caused by parasitic helminths, remains a major global health problem currently affecting over 250 million people in 78 countries with an additional 800 million people at risk of infection. Schistosoma haematobium causes female genital schistosomiasis and urinary schistosomiasis resulting in bladder cancer if left untreated. S. Haematobium infection often results in formation of lesions within the vaginal tract of women, often rendering them more susceptible to HIV coinfection. Since 2014, urogenital schistosomiasis is now being actively transmitted in southern europe, a region previously thought to be schistosomiasis-free. Over the course of 20 years, we have developed a potent schistosomiasis vaccine for S. Mansoni, termed schistoshield®, targeting a functionally important antigen, SM-P80, formulated using the TLR4-targeting adjuvant GLA-SE. Schistoshield® has been exhaustively tested in numerous animal models and has consistently exhibited protection at all parasite life cycle stages. We are near completion of a phase 1 safety and dose-ranging human clinical trial with schistoshield® in the US - with no safety signals reported - and will begin phase 1B trials in africa in Q3 of 2023 with a future phase 2 trial in africa to be funded by the gates foundation. We hypothesize that a SH-P80-based vaccine for S. Haematobium (HEMATOSHIELDTM) could be developed using our extensive experience with schistoshield®, and that this homologous vaccine will provide superior protection against urogenital schistosomiasis. In this sttr we propose two aims: (1) produce and release vaccine candidates and then to (2) evaluate the vaccine candidates in an animal model of urogenital schistosomiasis. Successful completion of these aims will be crucial identifying which candidate vaccine for this burdensome disease will be progressed into future current good manufacturing practice (CGMP) production, stability, potency, and toxicology testing as well as important clinical trials for efficacy against S. Haematobium.

Transactions

Action Obligated Date
Amendment $0
Original award $295,386

Subawards

Subrecipient Amount Awarded
Midwestern University Statement of Work: Schistosomiasis, caused by parasitic helminths, remains a major global health problem currently affecting over 250 million people in 78… $168,603

Quick answers

Who received award R41AI181069?

R41AI181069 was awarded to PAI Life Sciences Inc. by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on January 3, 2024.

How much is award R41AI181069 worth?

$295,386 has been obligated on R41AI181069.

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