HPV negativity was associated with a very low long-term risk of cervical cancer. Persistent detection of HPV among cytologically normal women greatly increased risk. Thus, it is useful to perform repeated HPV testing following an initial positive test.

Objective. An observational safety study of the quadrivalent human papillomavirus vaccine (HPV4) in women was conducted. This report presents findings from autoimmune surveillance. Design. Subjects were followed for 180 days after each HPV4 dose for new diagnoses of 16 prespecified autoimmune conditions. Setting. Two managed care organizations in California. Outcome. Potential new-onset autoimmune condition cases amongst HPV4 recipients were identified by electronic medical records. Medical records of those with ‡12-month health plan membership prior to vaccination were reviewed by clinicians to confirm the diagnosis and determine the date of disease onset. The incidence of each autoimmune condition was estimated for unvaccinated women at one study site using multiple imputations and compared with that observed in vaccinated women. Incidence rate ratios (IRR) were calculated. Findings were reviewed by an independent Safety Review Committee (SRC).Results. Overall, 1014 potential new-onset cases were electronically identified; 719 were eligible for case review; 31-40% were confirmed as new onset. Of these, no cluster of disease onset in relation to vaccination timing, dose sequence or age was found for any autoimmune condition. None of the estimated IRR was significantly elevated except Hashimoto's disease [IRR = 1.29, 95% confidence interval: 1.08-1.56]. Further investigation of temporal relationship and biological plausibility revealed no consistent evidence for a safety signal for autoimmune thyroid conditions. The SRC and the investigators identified no autoimmune safety concerns in this study.Conclusions. No autoimmune safety signal was found in women vaccinated with HPV4.

Objective: To estimate the incidence and duration of cervical human papillomavirus (HPV)-6, HPV-11, infections in a population of young American women. Methods: The study population consisted of U.S. women who at baseline were 16 to 23 years of age, reported zero to five lifetime sexual partners, never having been pregnant, and never having had a prior abnormal Papanicolaou test and were enrolled in the placebo arm of a randomized multicenter clinical trial of a HPV-16 L1 virus-like particle vaccine. Women underwent type-specific endocervical/ ectocervical swab HPV DNA testing at f6-month intervals for up to 48 months of follow-up. To contribute persontime in the analyses of type-specific HPV incidence, a woman must have had at least three satisfactory swab specimens available and been negative for the relevant HPV type (HPV-6, HPV-11, HPV-16, or HPV-18) on her first two trial swabs. The duration of incident HPV infections was estimated using Kaplan-Meier survival analysis methods.Results: Person-years of exposure ranged by type-specific analysis from 2,645 to 3,188, with an incidence rate per 100 person-years of 3.6 for HPV-6, 0.4 for HPV-11, 5.4 for HPV-16, and 2.1 for HPV-18. With censoring at the time of treatment for cervical intraepithelial neoplasia, where done, the mean duration of incident infections was 9.3, 8.4, 18.2, and 16.4 months, respectively, for HPV-6 (n = 103), HPV-11 (n = 13), HPV-16 (n = 142), and HPV-18 (n = 62). When the duration of HPV infections was truncated at the time of cervical intraepithelial neoplasia detection (any grade), where applicable, mean duration figures were 8.4, 8.1, 14.0, and 15.1 months for HPV-6, HPV-11, HPV-16, and HPV-18 infections, respectively. Conclusions: Previous studies of the mean duration of cervical HPV infection have been based on prevalent infections and/or featured relatively short duration of follow-up. This study tested women for HPV infection over a period of up to 48 months and observed a mean duration of incident HPV-16/ HPV-18 infections approximately twice that of HPV-6/ HPV-11. (Cancer Epidemiol Biomarkers Prev 2007;16(4):709-15)

To assess the safety of the quadrivalent human papillomavirus vaccine (HPV4) in females following routine administration. Design: In a cohort of vaccinated females, we compared the risk of emergency department visits and hospitalizations during the interval soon after vaccination with risk during a comparison interval more remote from vaccination.

Multiple sexual partners and early age at first intercourse have been identified as major risk factors for cervical cancer in earlier epidemiologic studies (Brinton, 1992), implying that sexually transmitted agents might be involved in its etiology. Over the last decade, mounting evidence from laboratory (zur Hausen, 1994) and epidemiologic (Muiioz et al., 1992; Peng et aZ., 1991) studies has shown that sexually transmitted infection with genital types of human papillomavirus (HPV) may be the primary causal agent for cervical cancer worldwide (Bosch et al., 1995). However, the relationship between HPV and cervical intraepithelial neoplasia (CIN) is less well established. Among epidemiologic studies investigating this relationship, few (Schiffman et al., 1993;Bosch et al., 1993;Morrison et al., 1991) have been able to use HPV DNA testing methods with high sensitivity and broad type range (Schiffman, 1992a;Burmer et al., 1990). In particular, epidemiologic studies investigating the relationship of HPV with CIN have been quite limited in Asia, even though cervical cancer is the most common cancer among women in this region (Parkin et al., 1992).Cervical cancer is the leading cancer among women in Taiwan (31% of all incident cancers in women) with an annual age-adjusted incidence rate of 33.5 per 100,000 (Cancer Registry Annual Report in Taiwan Area, 1986), which is about 4 times higher than that in the United States (8.7 per 100,000) (Miller et al., 1993). Reasons for the high risk in Taiwan are unclear, since the reported prevalence of known epidemiologic risk factors for cervical cancer, in particular multiple sexual partners, is quite low compared with Western women (Schiffman et al., 1993;Bosch et al., 1993;Morrison et al., 1991;Shen et al., 1993). However, approximately 90% of the women in Taiwan have never had a Papanicolaou (Pap) smear (Health Annual Report in Taiwan Area, 1993), which might be related to the high risk.As reported in Western countries (Bosch et al., 1995), a clinical report from China and Taiwan has shown that HPV could be detected in over 70% of cervical cancer patients (Pa0 et al., 1993), suggesting that HPV may be an important risk factor for cervical cancer in this monogamous female population. To investigate the role of HPV and other possible etiologic factors in the full spectrum of cervical neoplasia in Taiwan, we conducted a case-control study as part of a community-based cervical neoplasia screening study, using a sensitive HPV testing method that detects a broad range of HPV types (Manos et al., 1989). METHODS Study population (screened women)In 1991, a community-based cervical neoplasia screening study was conducted among women aged 30-64 in 4 rural townships in Taiwan with high cancer mortality rates. Women who had never been married or who had a history of cervical neoplasia or a hysterectomy were ineligible for the screening. As of June, 1992, 5,286 women had been recruited into the screening study. Briefly, at screening, Pap smears and cervigrams, magnified photographic imag...