In 2007, five Emerging Infections Program (EIP) sites were funded to determine the feasibility of establishing a population-based surveillance system for monitoring the effect of human papillomavirus (HPV) vaccine on pre-invasive cervical lesions. The project involved active population-based surveillance of cervical intraepithelial neoplasia grades 2 and 3 and adenocarcinoma in situ as well as associated HPV types in women >18 years of age residing in defined catchment areas; collecting relevant clinical information and detailed HPV vaccination histories for women 18-39 years of age; and estimating the annual rate of cervical cancer screening among the catchment area population. The first few years of the project provided key information, including data on HPV type distribution, before expected effect of vaccine introduction. The project's success exemplifies the flexibility of EIP's network to expand core activities to include emerging surveillance needs beyond acute infectious diseases. Project results contribute key information regarding the impact of HPV vaccination in the United States.

Background: Vaccination against human papillomavirus (HPV) types 16 and 18 is recommended for girls aged 11 or 12 years with catch-up vaccination through age 26 in the U.S. Cervical intraepithelial neoplasia (CIN) grade 2 or 3 and adenocarcinoma in situ (CIN2+) are used to monitor HPV vaccine impact on cervical disease. This report describes vaccination status in women diagnosed with CIN2+ and examines HPV vaccine impact on HPV 16/18-related CIN2+.Methods: As part of a vaccine impact monitoring project (HPV-IMPACT), females 18-31 years with CIN2+ were reported from pathology laboratories in CA, CT, NY, OR, TN from 2008 to 2011. One diagnostic block was selected for HPV DNA typing with Roche Linear Array. Demographic, abnormal Papanicolaou (Pap) test dates and vaccine status information were collected. The abnormal Pap test immediately preceding the CIN2+ diagnosis was defined as the 'trigger Pap'.Results: Among 5083 CIN2+ cases reported to date, 3855 had vaccination history investigated: 1900 had vaccine history documented (vaccinated, with trigger Pap dates, or unvaccinated). Among women who initiated vaccination >24 months before their trigger Pap, there was a significantly lower proportion of CIN2+ lesions due to 16/18 compared to women who were not vaccinated (aPR = .67, 95% CI: .48-.94). Among the 1900 with known vaccination status, 20% initiated vaccination on/after their trigger screening. Women aged 21-23 years were more likely to initiate vaccination on/after the trigger Pap compared to 24-26 year olds (29.0% vs. 19.6%, p = .001), as were non-Hispanic blacks compared to non-Hispanic whites (27.3% vs. 19.0%, p = .001) and publicly compared to privately insured women (38.1% vs. 17.4%, p < .0001).Conclusion: We found a significant reduction in HPV 16/18-related lesions in women with CIN2+ who initiated vaccination at least 24 months prior to their trigger Pap. These preliminary results suggest early impact of the HPV vaccine on vaccine-type disease, but further evaluation is warranted. Published by Elsevier Ltd.

The following paper describes a collaboration between the Centers for Disease Control and Prevention and five Emerging Infections Program sites to develop a comprehensive population-based approach to monitoring human papillomavirus (HPV) vaccine impact on cervical cancer precursors and associated HPV genotypes. The process of establishing this novel monitoring system is described, and development details such as enumeration of sources for reporting cervical intraepithelial neoplasia 2/3 and adenocarcinoma in situ, approaches to case ascertainment, electronic reporting, and HPV typing are outlined. Implementation of a feasible and sustainable surveillance system for HPV-associated cervical precancers will enable evaluation of the direct impact of HPV vaccination.

BACKGROUNDTwo vaccines protect against human papillomaviruses (HPV) 16 and 18, which cause 70% of cervical cancer and 50% of cervical intraepithelial neoplasia 2/3 and adenocarcinoma in situ (CIN2+). Monitoring HPV types in CIN2+ may be used to assess HPV vaccine impact.METHODSAs part of a multisite vaccine impact monitoring project (HPV-IMPACT), biopsy specimens used to diagnose CIN2+ were obtained for HPV DNA typing for women aged 18-39 years.RESULTSAmong 4,121 CIN2+ cases reported during 2008-2009 in 18- to 39-year-old women 3058 (74.2%) were tested; 96% were HPV DNA positive. HPV 16 was most common (49.1%), followed by HPV 31 (10.4%) and HPV 52 (9.7%). HPV 18 prevalence was 5.5% overall. Proportion of CIN2+ cases associated with HPV 16/18 was highest (56.3%) in 25- to 29-year-old women. HPV 16/18-associated lesions were less common in non-Hispanic blacks (41.9%) and Hispanics (46.3%) compared with non-Hispanic whites (59.1%) (P < .0001); the difference remained significant when adjusted for covariates. Compared to non-Hispanic whites, HPV 35 and 58 were significantly more common in non-Hispanic blacks (14.5% vs 4.2%; 12.3% vs 3.4%) and HPV 45 was higher in Hispanics (3.7% vs 1.5%).CONCLUSIONSAge and racial/ethnic differences in HPV type distribution may have implications for vaccine impact and should be considered in monitoring trends.