The National Cancer Institute (NCI) has awarded a $1,837,497 Cooperative Agreement under the Cancer Cause and Prevention Research (CFDA 93.393) program to New York University (NYU) for the KUPEWA project. The project aims to identify optimal implementation strategies for increasing clinician recommendation of HPV vaccination for girls and young women aged 9-24 living with HIV in Malawi. NYU is collaborating with the University of California, Los Angeles (UCLA) and the Malawi-based Partners In...
This $4,947,572 Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), will fund a cohort study to evaluate the effectiveness of the HPV vaccine in preventing anogenital disease among immunocompromised populations. The study will assess vaccine effectiveness across three distinct groups: people living with HIV, people with autoimmune conditions, and people with a history of solid...
This Project Grant award from the National Institutes of Health under the Trans-NIH Research Support program (CFDA 93.310) provides $1,382,625.00 to Purdue University to address cervical cancer disparities among people experiencing homelessness. The key objectives are to: 1) estimate cervical cancer screening coverage and associated factors among homeless communities in Indiana; 2) identify barriers and facilitators to screening, follow-up, and linkage to care; 3) assess the acceptability and...
This Project Grant award, valued at $233,411.00, was awarded by the National Cancer Institute (NCI) under the federal grant program "Cancer Cause and Prevention Research" (CFDA 93.393). The grant aims to evaluate the impact of a narrative communication intervention delivered through digital and mobile technologies on HPV vaccine initiation rates among 9- to 12-year-old children. The study, titled "STORIES TO PREVENT (STOP) HPV CANCERS," will recruit cancer survivors to film...
This Project Grant award from the National Cancer Institute (CFDA 93.396 Cancer Biology Research) provides $630,506 to The Johns Hopkins University to develop novel therapeutic cancer vaccines targeting human papillomavirus (HPV) for the treatment of cervical cancer. The primary goal is to employ spontaneous HPV cervicovaginal carcinoma models to characterize immune evasion mechanisms of HPV E6/E7 variants and evaluate the efficacy of a DNA vaccine against different HPV16 variants. The...
The University of North Carolina at Chapel Hill was awarded a $157,744 Project Grant by the Agency for Healthcare Research and Quality (AHRQ) under the Research on Healthcare Costs, Quality and Outcomes (CFDA 93.226) federal grant program. The grant will fund a 4-year research project to develop and pilot an intervention to increase HPV vaccination coverage among rural adolescents in North Carolina. The key objectives of the project are to: 1) define optimal systems for recommending HPV...
This Project Grant award from the National Cancer Institute (CFDA 93.393 - Cancer Cause and Prevention Research) aims to develop and evaluate an intervention to improve cervical cancer screening and follow-up rates in three diverse, underserved populations: urban inner city Blacks/Haitians (Boston), Hispanic immigrants (Florida), and Hawaiian Natives/Pacific Islanders (Hawaii). The $753,446 award will be used to adapt a successful HPV vaccination intervention for cervical cancer screening,...
Morphogenesis, Inc. was awarded a $1,200,000 Project Grant from the National Cancer Institute, part of the Department of Health and Human Services, to develop a low-cost topical immunotherapy formulation suitable for treating cervical cancer in low- and middle-income countries and low-resource settings in the United States. The funding supports optimization of Morphogenesis' IFX-HU2.1 plasmid DNA-based cream formulation for temperature stability using established methods and models. In vitro...
The National Cancer Institute (NCI) awarded a $191,700 Project Grant under the Cancer Research Manpower (CFDA 93.398) program to Northwestern University. The 5-year grant, which began on January 15, 2025, will support a pilot trial to assess the feasibility, acceptability, and effects of four digital intervention components (expert video, self-persuasion, narrative storytelling, and motivational interviewing) aimed at increasing HPV vaccination rates among the U.S. Vietnamese population. The...
This $585,943 Cooperative Agreement awarded by the National Cancer Institute (CFDA 93.394 - Cancer Detection and Diagnosis Research) aims to develop a low-cost, rapid, and easy-to-use point-of-care HPV DNA test to improve cervical cancer screening in Mozambique. The project will: 1) Adapt an extraction-free, multiplexed isothermal nucleic acid amplification assay to detect high-risk HPV types on an integrated nucleic acid amplification and lateral flow detection platform called NATFLOW; 2)...
TRANSLATIONAL USE OF INTRADERMAL NEEDLE-FREE INJECTOR TO FACILITATE AND OPTIMIZE GLOBAL FRACTIONAL DOSE HPV VACCINE ADMINISTRATION - PROJECT SUMMARY CERVICAL CANCER IS THE FOURTH MOST COMMON CANCER IN WOMEN, CONTRIBUTING TO ABOUT 570,000 NEW CASES AND MORE THAN 300,000 DEATHS IN 2018, MOST OF IT OCCURS IN THE LOW- AND MIDDLE-INCOME COUNTRIES (BRAY, 2018). IN INDONESIA, CERVICAL CANCER IS THE SECOND MOST PREVALENT TYPE OF CANCER AMONG WOMEN, WITH 32,000 NEW CASES AND 18,000 DEATHS (GLOBAL CANCER OBSERVATORY, 2019). IT HAS BEEN SHOWN THAT HUMAN PAPILLOMAVIRUS (HPV) INFECTION IS THE MAJOR CAUSATIVE AGENT OF CERVICAL CANCER (BOSCH, 2002). IN 2017, WHO RELEASED AN HPV VACCINE POSITION PAPER THAT STATED HPV VACCINES SHOULD BE INCLUDED IN NATIONAL IMMUNIZATION PROGRAMS WITH ITS PRIMARY TARGET POPULATION IS 9-14 YEAR OLD GIRLS, PRIOR TO BECOMING SEXUALLY ACTIVE (WORLD HEALTH ORGANIZATION, 2017). VACCINATION REPRESENTS THE MOST COST-EFFECTIVE AND EFFICIENT WAY FOR THE PREVENTION OF CERVICAL CANCER CAUSED BY HUMAN PAPILLOMAVIRUS. CURRENTLY, HPV VACCINE HAS BEEN INTRODUCED IN NEARLY 100 COUNTRIES GLOBALLY (52%), MAINLY IN THE UPPER-MIDDLE- AND HIGH-INCOME COUNTRIES. HOWEVER, ITS ACCESS IN THE HIGHEST BURDEN COUNTRIES (LOW AND MIDDLE INCOME) REMAINS LAGGING. FURTHERMORE, PREVIOUS DATA COLLECTED BY GLOBAL HEALTH ORGANIZATIONS HAVE SHOWN CONTINUED LOW COMPLIANCE RATES FOR HPV VACCINES, PARTLY ATTRIBUTABLE TO NEEDLE-PHOBIA. IT IS PREDICTED THAT THIS ISSUE WILL PERSIST UNLESS A NEW STRATEGY FOR VACCINATION IS INTRODUCED. IN THIS DIRECT TO PHASE II PROPOSAL, WE WILL EXPLORE THE FEASIBILITY AND POTENTIAL BENEFITS OF A REDUCED DOSE INTRADERMAL STRATEGY FOR HPV VACCINES. IN THIS LARGER STUDY, WE WILL EVALUATE DOSES AND ROUTES OF ADMINISTRATION TO DETERMINE THE IMMUNOGENICITY, REACTOGENICITY, AND LEVELS OF PATIENT AND CAREGIVER ACCEPTANCE FOR EACH. IN SETTINGS WITH MINIMAL RESOURCES, THE BENEFITS OF DELIVERY WITH NEEDLE-FREE INJECTION ARE PREDICTED TO INCLUDE DOSE SAVINGS, INCREASED COMPLIANCE, AND THE PREVENTION OF NEEDLE-STICK INJURIES AND DISEASE TRANSMISSION. THE RESULTS FROM THESE STUDIES WILL PROVIDE CLINICAL DATA TO ANSWER THE MAIN PROBLEMS WITH THE CURRENT HPV VACCINE SCHEDULE: 1) AVAILABILITY OF VACCINE DOSES; 2) COST; AND 3) ACCEPTABILITY & COMPLIANCE. THIS DATA WILL BE A FIRST STEP TO FACILITATE FUTURE POLICY DISCUSSIONS AND GLOBAL HEALTH STRATEGIES REGARDING ADMINISTRATION OF FIHPV VACCINES ACROSS INDONESIA AND OTHER DEVELOPING COUNTRIES. THE IMMEDIATE NEXT STEPS WILL INCLUDE PLANNING A LARGER ROLL-OUT CAMPAIGN ACROSS MULTIPLE AREAS OF INDONESIA, NOTABLY IN FURTHER REMOTE AREAS WHERE VACCINATION COMPLIANCE HAS BEEN HISTORICALLY LOW. ULTIMATELY, THESE STUDIES WILL BE USED AS A TOOL TO INCREASE AWARENESS OF THE PHARMAJET TROPIS NEEDLE- FREE INJECTION SYSTEM AS A METHOD FOR FIHPV ADMINISTRATION THAT MAY AID IN COUNTRY-WIDE AND WORLDWIDE VACCINE COMPLIANCE AND ACCEPTABILITY TO SCHEDULES AS RECOMMENDED BY THE WHO AND MINISTRIES OF HEALTH.