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A Phase II Evaluation of the Safety and Protective Efficacy of the Live Attenuated Tetravalent Dengue Vaccine TetraVax-DV with Challenge by the Recombinant DENV-2 Virus in a Dengue Endemic Population

Award Number: U01AI134582
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY Dengue viruses cause more human morbidity than any other arbovirus, underscoring the public health urgency of making safe and effective dengue vaccines available in endemic settings, in alignment with NIAID priorities. This critical need will be addressed by testing the safety and protective efficacy of NIAID's lead tetravalent, live attenuated dengue vaccine candidate, TV005, in adults in dengue-endemic Bangladesh through a vaccine-challenge trial based on the Dengue Controlled Human Infection Model (D-CHIM). Our central hypothesis is that vaccination with TV005 will protect against infection with a live, recombinant dengue 2 challenge virus (DENV-2), with DENV-2 viremia following challenge as the primary efficacy endpoint. In addition to extensive Phase I and II trials leading to the development of TV005, our team has used a similar vaccine-challenge design to evaluate the safety and efficacy of TV005 in dengue-naïve U.S. adults, which was well-tolerated and >99% efficacious in preventing viremia. The next critical step for NIAID's promising vaccine is to test its safety and efficacy in a dengue-endemic setting. In this study, 224 healthy adult volunteers, both dengue-exposed and -naïve, will be enrolled and randomized 1:1 (vaccine: placebo) to receive TV005 followed by inpatient challenge with DENV-2 at 6 or 24 months post-vaccination. To test our central hypothesis, we will pursue the following Specific Aims: Aim 1A) Determine, in a dengue endemic population, the protective efficacy of TV005 vaccine against dengue infection induced by a live, recombinant DENV-2 challenge virus (rDEN2∆30-7169) administered 6 or 24 months after vaccination; Aim 1B) Evaluate the safety of TV005 and the DEN-2 challenge virus in a dengue endemic population; and Aim 2) Use predictive modeling to identify baseline and post-vaccination immune phenotype(s) that predict TV005 efficacy and safety to better understand response to vaccination and protective immunity, and to inform future study design for dengue vaccine development in endemic settings. In contrast to large-scale field trails, the D-CHIM will provide early vaccine efficacy and safety signals while enrolling a minimal number of volunteers, and contribute to our understanding of the immune response to both vaccination and challenge in an endemic setting through statistical modeling of vaccine impact.


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: 2024 ( Subtotal = $1,224,706 )
2024	2024	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT STREET	BURLINGTON	VT	05405	CHITTENDEN	USA	Allergy and Infectious Diseases Research	000	5	8/1/2024	NON-COMPETING CONTINUATION	$1,224,706
														Subtotal = $1,224,706

Issue Date FY: 2023 ( Subtotal = $1,249,406 )
2023	2023	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT STREET	BURLINGTON	VT	05405	CHITTENDEN	USA	Allergy and Infectious Diseases Research	000	4	7/18/2023	NON-COMPETING CONTINUATION	$1,249,406
														Subtotal = $1,249,406

Issue Date FY: 2022 ( Subtotal = $1,239,797 )
2022	2022	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Allergy and Infectious Diseases Research	000	3	7/29/2022	NON-COMPETING CONTINUATION	$1,239,797
														Subtotal = $1,239,797

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Allergy and Infectious Diseases Research	000	2	8/12/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1,319,208 )
2020	2020	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Allergy and Infectious Diseases Research	000	2	7/20/2020	NON-COMPETING CONTINUATION	$1,319,208
														Subtotal = $1,319,208

Issue Date FY: 2019 ( Subtotal = $1,300,717 )
2019	2019	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Allergy and Infectious Diseases Research	000	1	8/21/2019	NEW	$1,300,717
														Subtotal = $1,300,717

Grand Total All Awards = $6,333,834

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A Phase II Evaluation of the Safety and Protective Efficacy of the Live Attenuated Tetravalent Dengue Vaccine TetraVax-DV with Challenge by the Recombinant DENV-2 Virus in a Dengue Endemic Population

Award Number: U01AI134582

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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