Monday, June 30, 2025 6/30/2025

Understanding and Enhancing T-Cell Responses to High Risk Human Papillomaviruses-Renewal

Award Number: R01CA143130
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2010
PERIOD OF PERFORMANCE END DATE: 06/30/2026

Group Awards By:

View Award Description

Understanding and Enhancing T-Cell Responses to High Risk Human Papillomaviruses-Renewal - PROJECT SUMMARY It is estimated that human papillomavirus (HPV) is responsible for 42,700 cancers in the US each year and that it caused more than 90% of anal and cervical cancers and about 70% of oropharyngeal, vaginal, and vulvar cancers. The increases in incidences of HPV-associated anal and oropharyngeal cancers in the US are notable, and cervical cancer is the fourth most common cancer among women globally. This is the second competitive renewal of this R01, which has the long-term goal of developing therapeutic vaccines for HPV. This is significant because currently available prophylactic vaccines are effective only for preventing HPV infections, but not for eliminating them once they are established. The estimated lifetime probably of acquiring HPV is 91.3% for men and 84.6% for women. We developed and are testing PepCan, a therapeutic vaccine that consists of four “current good manufacturing grade” synthetic peptides that cover the E6 protein of HPV type 16 (HPV 16), along with a Candida skin-test reagent as a novel vaccine adjuvant. Our dose-escalation single- site Phase I clinical trial of PepCan to treat women with cervical high-grade squamous intraepithelial lesions (HSILs) was recently completed. It demonstrated safety, a significant decrease in HPV 16 viral load, and a significant increase in circulating T-helper type 1 cells after vaccination. A randomized (to two treatment arms), double-blind, Phase II clinical trial is on track to complete recruitment soon. Furthermore, in a double-blind, placebo-controlled (3:1 ratio) Phase I/II clinical trial, PepCan is being tested to reduce recurrence of squamous cell carcinoma of head and neck in patients who reach “no evidence of disease” status after curative treatment. The following aims will test our hypothesis that PepCan induces HPV-specific immune responses, resulting in reduced recurrence of head and neck cancer (HNC) and increased regression of HSILs when the effector cells (i.e., T-cells) reach the disease sites. Aim 1: Assess efficacy and safety of our HPV therapeutic vaccine for HNC recurrence reduction and cervical HSIL regression Aim 2: Examine immune factors that influence PepCan response and vaccine mechanisms Aim 3: Examine how microbiomes of gut and of disease sites (cervix and mouth) contribute to vaccine efficacy Results of the proposed investigations may lead to FDA approval of a therapeutic vaccine for two HPV-related cancers and to an improved understanding of immunotherapy mechanisms.


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: 2025 ( Subtotal = $727,264 )
2025	2025	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	000	15	6/17/2025	NON-COMPETING CONTINUATION	$727,264
														Subtotal = $727,264

Issue Date FY: 2024 ( Subtotal = $690,909 )
2024	2024	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	000	14	5/31/2024	NON-COMPETING CONTINUATION	$690,909
														Subtotal = $690,909

Issue Date FY: 2023 ( Subtotal = $727,275 )
2023	2023	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	000	13	6/14/2023	NON-COMPETING CONTINUATION	$727,275
														Subtotal = $727,275

Issue Date FY: 2022 ( Subtotal = $712,726 )
2022	2022	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	002	12	7/7/2022	NON-COMPETING CONTINUATION	$712,726
2022	2021	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	001	11	11/19/2021	COMPETING CONTINUATION	$33,252
2022	2020	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	000	10	11/19/2021	NON-COMPETING CONTINUATION	-$33,252
														Subtotal = $712,726

Issue Date FY: 2021 ( Subtotal = $727,272 )
2021	2021	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	001	11	6/1/2021	COMPETING CONTINUATION	$727,272
2021	2020	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	000	10	5/18/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $727,272

Issue Date FY: 2020 ( Subtotal = $721,276 )
2020	2020	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	001	10	1/23/2020	NON-COMPETING CONTINUATION	$72,127
2020	2020	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	000	10	11/27/2019	NON-COMPETING CONTINUATION	$649,149
														Subtotal = $721,276

Issue Date FY: 2019 ( Subtotal = $699,636 )
2019	2019	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	000	9	11/26/2018	NON-COMPETING CONTINUATION	$699,636
														Subtotal = $699,636

Issue Date FY: 2018 ( Subtotal = $721,272 )
2018	2018	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	000	8	11/20/2017	NON-COMPETING CONTINUATION	$649,144
2018	2018	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	001	8	5/22/2018	NON-COMPETING CONTINUATION	$72,128
														Subtotal = $721,272

Issue Date FY: 2017 ( Subtotal = $721,274 )
2017	2017	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	001	7	6/7/2017	NON-COMPETING CONTINUATION	$72,127
2017	2017	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	000	7	11/16/2016	NON-COMPETING CONTINUATION	$649,147
														Subtotal = $721,274

Issue Date FY: 2016 ( Subtotal = $545,019 )
2016	2016	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST, M S 545	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	001	6	11/25/2015	COMPETING CONTINUATION	$545,019
2016	2014	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST, M S 545	LITTLE ROCK	AR	722059985	PULASKI	USA	Cancer Treatment Research	000	5	11/23/2015	NON-COMPETING CONTINUATION	$0
														Subtotal = $545,019

Issue Date FY: 2014 ( Subtotal = $476,773 )
2014	2014	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST, M S 545	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	000	5	4/30/2014	NON-COMPETING CONTINUATION	$476,773
														Subtotal = $476,773

Issue Date FY: 2013 ( Subtotal = $464,563 )
2013	2013	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST, M S 545	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	001	4	7/1/2013	NON-COMPETING CONTINUATION	$348,422
2013	2013	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST, M S 545	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	000	4	5/1/2013	NON-COMPETING CONTINUATION	$116,141
														Subtotal = $464,563

Issue Date FY: 2012 ( Subtotal = $639,225 )
2012	2012	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST, M S 545	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	000	3	4/11/2012	NON-COMPETING CONTINUATION	$639,225
														Subtotal = $639,225

Issue Date FY: 2011 ( Subtotal = $699,449 )
2011	2011	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST, M S 545	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	001	2	5/16/2011	NON-COMPETING CONTINUATION	$31,006
2011	2011	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST, M S 545	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	000	2	3/31/2011	NON-COMPETING CONTINUATION	$668,443
														Subtotal = $699,449

Issue Date FY: 2010 ( Subtotal = $774,808 )
2010	2010	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST, M S 545	LITTLE ROCK	AR	72205	PULASKI	USA	Cancer Treatment Research	000	1	5/27/2010	NEW	$774,808
														Subtotal = $774,808

Grand Total All Awards = $10,048,741

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Understanding and Enhancing T-Cell Responses to High Risk Human Papillomaviruses-Renewal

Award Number: R01CA143130

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/01/2010

PERIOD OF PERFORMANCE END DATE: 06/30/2026

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer