# Epidemiologic Impact of HPV Vaccination

> **NIH NIH R01** · CINCINNATI CHILDRENS HOSP MED CTR · 2022 · $637,576

## Abstract

Project Summary
Introduction of prophylactic human papillomavirus (HPV) vaccines has the potential to dramatically decrease
morbidity and mortality from anogenital and oropharyngeal cancers. However, data from vaccine clinical trials
cannot predict vaccine effectiveness in “real-world” community settings, and introduction of a 9-valent (in
addition to a 2- and 4-valent) vaccine in 2015 and reduced dosing schedules (from 3 to 2 doses) in 2016 could
further modify vaccine effectiveness. The impact of vaccine introduction can be efficiently and accurately
evaluated by HPV surveillance studies that assess vaccine effectiveness, herd protection, cross-protection
(decrease in HPV types genetically related to vaccine types), and type replacement (increase in non-vaccine-
type HPV due to a reduction in vaccine types). We previously conducted 4 HPV surveillance studies in women
(2006-2017) and 2 in men (2013-2017). Among women, we found evidence for vaccine effectiveness (but
lower effectiveness with 1 vs. 3 doses), herd protection, and cross-protection; no evidence for type-
replacement; and an unexpected increase in non-vaccine-type HPV in unvaccinated women. Among men, we
found preliminary evidence for vaccine effectiveness and herd protection. Continued investigation through the
proposed renewal is essential to achieve the following objectives: 1) assess the effects of 9-valent vaccine
introduction and reduced dosing schedules on effectiveness, 2) elucidate long-term trends in herd protection,
3) identify signals of diminished cross-protection or emerging type-replacement, and 4) determine mechanisms
for increases in non-vaccine-type HPV in unvaccinated women. The specific aims are to: 1) determine long-
term trends in 4-valent - and emerging trends in 9-valent - HPV prevalence among vaccinated women (2006-
2023) and men (2013-2023) to assess HPV vaccine effectiveness, and among unvaccinated women and men
to assess herd protection; 2) assess the differential impact of the number of vaccine doses received on
vaccine-type HPV, by age; 3) determine trends in non-vaccine-type HPV prevalence among vaccinated women
and men, to examine for persistent cross-protection and emerging type replacement; and 3) explore biological
and behavioral mechanisms for the increase in non-vaccine-type HPV in unvaccinated women. Our approach
will be to enroll 1,600 women and men in two additional surveillance studies, to characterize the impact of
vaccine introduction across a total of 6 time periods in women (2006-2023, N=2,400) and 4 in men (2013-
2023, N=1,600). The proposed research is innovative because the resulting data could shift current research
and clinical practice paradigms in the areas of vaccination and virology, and the research plan utilizes novel
concepts, approaches and new methodologies to explore mechanisms driving HPV trends. The proposed
research is significant because the data will provide key evidence for: 1) vaccination and cervical cancer
screening ...

## Key facts

- **NIH application ID:** 10451708
- **Project number:** 5R01AI104709-09
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** Lili Ding
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $637,576
- **Award type:** 5
- **Project period:** 2013-01-18 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10451708

## Citation

> US National Institutes of Health, RePORTER application 10451708, Epidemiologic Impact of HPV Vaccination (5R01AI104709-09). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10451708. Licensed CC0.

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