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Development of an Innovative, Effective RNA-based Vaccine for Chikungunya Virus

Award Number: R43AI127053
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/15/2017
PERIOD OF PERFORMANCE END DATE: 11/30/2018

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Development of an Innovative, Effective RNA-based Vaccine for Chikungunya Virus - PROJECT SUMMARY/ABSTRACT: Chikungunya virus (CHIKV) is an emerging disease of global public health importance. Originally identified in 1952, sporadic CHIKV outbreaks occurred in Africa and Asia for several decades. Beginning with an outbreak on the island of La Reunion in 2004 the virus has continued to spread to new regions around the globe. CHIKV is now endemic in the Caribbean, is present in the Americas, and continues to cause devastating outbreaks in India and Southeast Asia. Chikungunya vaccine development began with the generation of both traditional inactivated whole virus vaccines as well as live attenuated candidates. Additional advancement came in the development of viral vectored and subunit vaccines. Recently, two candidate vaccines have progressed into Phase 1 and Phase 2 clinical testing. However, until these vaccines are proven, additional candidates are sorely needed. The recent development of vector independent RNA based delivery systems represents an attractive platform for rapid and inexpensive development of new vaccine candidates. RNA based antigen delivery candidates may be generated and purified using a common fully synthetic process, which alleviates the need for time consuming antigen specific process development. Central to the utility of this platform is the development of an effective RNA delivery formulation, capable of promoting in vivo expression of antigen proteins from vaccine candidates following injection. This phase I SBIR proposal will utilize a proprietary and compositionally unique RNA delivery formulation to develop novel RNA based CHIKV vaccine candidates. Following generation of vaccine candidate RNA, we will verify viral protein expression and quantify secreted virus-like particles in vitro. In addition, we will verify that RNA vaccines do not generate replicating virus relative to a full length CHIKV [181/25] genome control by titration of transfection supernatants. Candidates shown to generate viral proteins in the absence of replication competent virus will be advanced into immunogenicity studies in mice. Comprehensive analysis of the immune response including the induction of CHIKV neutralizing antibody will confirm potency of RNA vaccine. Following down selection to two lead candidate RNA vaccines, we will carry out efficacy testing in multiple mouse challenge models. The results of these challenge studies will define two novel CHIKV vaccine candidates, which will then be advanced into cGMP manufacturing, toxicology and clinical testing in a subsequent SBIR Phase II proposal.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2019 ( Subtotal = -$22,102 )
2019	2017	PAI LIFE SCIENCES, INC.	1616 EASTLAKE AVE E STE 550	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	000	1	5/7/2019	NEW	-$22,102
														Subtotal = -$22,102

Issue Date FY: 2017 ( Subtotal = $224,998 )
2017	2017	PAI LIFE SCIENCES, INC.	1616 EASTLAKE AVE E STE 550	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	000	1	3/14/2017	NEW	$224,998
														Subtotal = $224,998

Grand Total All Awards = $202,896

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Development of an Innovative, Effective RNA-based Vaccine for Chikungunya Virus

Award Number: R43AI127053

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/15/2017

PERIOD OF PERFORMANCE END DATE: 11/30/2018

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