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1.  Association between Trichomonas vaginalis and vaginal bacterial community composition among reproductive-age women 
Sexually transmitted diseases  2012;39(10):807-812.
Objectives
Some vaginal bacterial communities are thought to prevent infection by sexually transmitted organisms. Prior work demonstrated that the vaginal microbiota of reproductive-age women cluster into five types of bacterial communities; 4 dominated by Lactobacillus species (L. iners, L. crispatus, L. gasseri, L. jensenii), and one (termed community state type (CST) IV) lacking significant numbers of lactobacilli and characterized by higher proportions of Atopobium, Prevotella, Parvimonas, Sneathia, Gardnerella, Mobiluncus, and other taxa. We sought to evaluate the relationship between vaginal bacterial composition and Trichomonas vaginalis.
Methods
Self-collected vaginal swabs were obtained cross-sectionally from 394 women equally representing four ethnic/racial groups. T. vaginalis screening was performed using PCR targeting the 18S rRNA and β-tubulin genes. Vaginal bacterial composition was characterized by pyrosequencing of barcoded 16S rRNA genes. A panel of eleven microsatellite markers was used to genotype T. vaginalis. The association between vaginal microbiota and T. vaginalis was evaluated by exact logistic regression.
Results
T. vaginalis was detected in 2.8% of participants (11/394). Of the eleven T. vaginalis-positive cases, eight (72%) were categorized as CST-IV, two (18%) as communities dominated by L. iners and one (9%) as L. crispatus-dominated (p-value:0.05). CST-IV microbiota were associated with an 8-fold increased odds of detecting T. vaginalis compared to women in the L. crispatus-dominated state (OR:8.26, 95% CI:1.07–372.65). Seven of the 11 T. vaginalis isolates were assigned to two genotypes.
Conclusion
T. vaginalis was associated with vaginal microbiota consisting of low proportions of lactobacilli and high proportions of Mycoplasma, Parvimonas, Sneathia, and other anaerobes.
doi:10.1097/OLQ.0b013e3182631c79
PMCID: PMC3458234  PMID: 23007708
Trichomonas vaginalis; vaginal microbiota
2.  Imiquimod 3.75% Cream Applied Daily to Treat Anogenital Warts: Combined Results from Women in Two Randomized, Placebo-Controlled Studies 
Objective. To evaluate if new imiquimod formulations using a shorter treatment duration are safe and efficacious to treat anogenital warts. Methods. In two studies 534 women ≥12 years of age (mean 33.4) with 2–30 warts (mean 7.9) and total wart area ≥10 mm2 (mean 166.3) were randomized (1 : 2 : 2) to placebo (106), imiquimod 2.5% (212) or 3.75% (216) creams applied once daily until complete clearance or a maximum of 8 weeks. Results. For placebo, imiquimod 2.5% and 3.75%, respectively, complete clearance of all warts was achieved in 14.2%, 28.3%, and 36.6% of women (intent-to-treat, P = 0.008 imiquimod 2.5%, and P < 0.001 3.75% versus placebo). Mean changes in wart counts were −10.7%, −50.9%, and −63.5% (per-protocol, P < 0.001 each active versus placebo) and safety-related discontinuation rates 0.9%, 1.4%, and 2.3%. Conclusions. Imiquimod 3.75% applied daily for up to 8 weeks was well tolerated and superior to placebo in treating women with external anogenital warts.
doi:10.1155/2011/806105
PMCID: PMC3162968  PMID: 21876641
3.  Chlamydia trachomatis infection and risk of cervical intraepithelial neoplasia 
Sexually Transmitted Infections  2011;87(5):372-376.
Objectives
High-risk human papillomavirus (hrHPV) is the primary cause of cervical cancer. As Chlamydia trachomatis is also linked to cervical cancer, its role as a potential co-factor in the development of cervical intraepithelial neoplasia (CIN) grade 2 or higher was examined.
Methods
The placebo arms of two large, multinational, clinical trials of an HPV6/11/16/18 vaccine were combined. A total of 8441 healthy women aged 15–26 years underwent cervicovaginal cytology (Papanicolaou (Pap) testing) sampling and C trachomatis testing at day 1 and every 12 months thereafter for up to 4 years. Protocol-specified guidelines were used to triage participants with Pap abnormalities to colposcopy and definitive therapy. The main outcome measured was CIN.
Results
At baseline, 2629 (31.1%) tested positive for hrHPV DNA and 354 (4.2%) tested positive for C trachomatis. Among those with HPV16/18 infection (n=965; 11.4%) or without HPV16/18 infection (n=7382, 87.5%), the hazard ratios (HRs) associated with development of any CIN grade 2 according to baseline C trachomatis status were 1.82 (95% CI: 1.06 to 3.14) and 1.74 (95% CI 1.05 to 2.90), respectively. The results were comparable when only the 12 most common hrHPV infections were considered, but the excess risk disappeared when the outcome was expanded to include CIN grade 3 or worse.
Conclusion
Further studies based on larger cohorts with longitudinal follow-up in relation to the C trachomatis acquisition and a thorough evaluation of temporal relationships of infections with hrHPV types, C trachomatis and cervical neoplasia are needed to demonstrate whether and how in some situations C trachomatis sets the stage for cervical carcinogenesis.
Trial registration
NCT00092521 and NCT00092534.
doi:10.1136/sti.2010.044354
PMCID: PMC3252607  PMID: 21471141
Chlamydia trachomatis
4.  Barriers to cervical cancer screening in Mulanje, Malawi: a qualitative study 
Background:
In Malawi, cervical cancer is the most prevalent form of cancer among women, with an 80% mortality rate. The Mulanje Mission Hospital has offered free cervical cancer screening for eight years; however, patients primarily seek medical help for gynecologic complaints after the disease is inoperable.
Methods:
We investigated how women in rural Malawi make health-seeking decisions regarding cervical cancer screening using qualitative research methods. The study was conducted between May and August of 2009 in Mulanje, Malawi.
Results:
This study found that the primary cue to action for cervical cancer screening was symptoms of cervical cancer. Major barriers to seeking preventative screening included low knowledge levels, low perceived susceptibility and low perceived benefits from the service. Study participants did not view cervical cancer screening as critical health care. Interviews suggested that use of the service could increase if women are recruited while visiting the hospital for a different service.
Conclusion:
This study recommends that health care providers and health educators target aspects of perceived susceptibility among their patients, including knowledge levels and personal risk assessment. We believe that continued support and advertisement of cervical cancer screening programs along with innovative recruitment strategies will increase usage density and decrease unnecessary deaths from cervical cancer in Malawi.
doi:10.2147/PPA.S17317
PMCID: PMC3063659  PMID: 21448296
cervical cancer; interviews; health care; Mulanje Mission Hospital
5.  Comparison of Self-Collected and Physician-Collected Vaginal Swabs for Microbiome Analysis▿ † 
Journal of Clinical Microbiology  2010;48(5):1741-1748.
To our knowledge, no data are available on whether the microbial species composition and abundance sampled with self-collected vaginal swabs are comparable to those of swabs collected by clinicians. Twenty healthy women were recruited to the study during a routine gynecological visit. Eligible women were between 18 and 40 years old with regular menstrual cycles. Participants self-collected a vaginal swab using a standardized protocol and then were examined by a physician, who collected an additional five swabs from the lateral wall of the mid-vagina. In this study, the self-collected and three physician-obtained swabs were analyzed and compared using terminal restriction fragment length polymorphism and sequence analyses of the 16S rRNA genes. Vaginal microbial community comparative statistical analyses of both T-RFLP and 16S rRNA gene sequence datasets revealed that self-collected vaginal swabs sampled the same microbial diversity as physician collected swabs of the mid-vagina. These findings enable large-scale, field-based studies of the vaginal microbiome.
doi:10.1128/JCM.01710-09
PMCID: PMC2863907  PMID: 20200290
6.  Telomerase Activity as a Potential Diagnostic Marker for Triage of Abnormal Pap Smears 
Objectives
To determine whether there is an association between high levels of telomerase and premalignant cervical disease and to provide a preliminary analysis of telomerase activity as a potential triage strategy.
Materials and Methods
Premenopausal women were invited to participate in the study during routine gynecologic visits as well as visits where colposcopy was performed. Samples were taken from the cervix using a broom device and placed in cold phosphate-buffered saline. A total of 92 samples were evaluated. Cells were counted and lysed, and a semi-quantitative measure of telomerase activity was determined using a commercially available telomerase enzyme-linked immunosorbent assay kit. The presence of human papillomavirus (HPV) types 16 and 18 was assessed by polymerase chain reaction analysis. One-way analysis of variance was used to test for the association of telomerase activity with cytology, HPV type 16 or 18 status, and colposcopy and/or biopsy findings.
Results
When telomerase levels were analyzed according to Pap smear results, there were no differences among four groups of cytology findings (normal, atypical squamous cells of undetermined significance, low-grade squamous intraepithelial lesion, and high-grade squamous intraepithelial lesion). When colposcopy and/or biopsy results were considered, significantly higher levels of telomerase were detected in cervical intraepithelial neoplasia (CIN) 2,3 samples than in normal Pap smear samples and CIN 1 samples (p = .035). There was no significant difference in telomerase levels between samples that tested positive for HPV type 16 or 18 and those that did not (p = .111).
Conclusions
Telomerase levels were significantly higher in cytologic samples from women with biopsy-proven CIN 2,3 than in samples from women with normal cytology results or CIN 1. These results warrant larger studies to determine whether telomerase activity may be a useful triage tool for abnormal cytologic findings.
PMCID: PMC2223068  PMID: 15870530
telomerase; Pap smear; CIN; papillomavirus
7.  Adherence and Blocking of Candida Albicans to Cultured Vaginal Epithelial Cells: Treatments to Decrease Adherence 
Background. Pathogenesis of mucosal microorganisms depends on adherence to the tissues they colonize and infect. For Candida albicans, cell surface hydrophobicity may play a significant role in tissue binding ability. Methods. A continuous cell line of vaginal epithelial cells (VEC) was grown in keratinocyte serum-free medium (KSFM) with supplements and harvested by trypsinization. VEC were combined with yeast cells to evaluate adherence and inhibition of adherence. In this experimental setup, yeast stained with fluorescein isothiocyanate were allowed to attach to VEC and the resulting fluorescent VEC were detected by flow cytometry. Results. VEC were cultured and examined daily after plating and showed morphology similar to basal epithelial cells. Culture media supplemented with estradiol showed increased VEC proliferation initially (first 24 h) but cell morphology was not altered. Fluorescinated Candida cells bound effectively to the cultured VEC. Using fresh cells exposed to various preparations of K-Y, we showed that all formulations of the product reduced Candida binding to VEC by 25% to 50%. While VEC were generally harvested for use in experiments when they were near confluent growth, we allowed some cultures to grow beyond that point and discovered that cells allowed to become overgrown or stressed appeared to bind yeast cells more effectively. Conclusion. Flow cytometry is a useful method for evaluating binding of stained yeast cells to cultured VEC and has demonstrated that commercially available products have the ability to interfere with the process of yeast adherence to epithelial cells.
doi:10.1155/IDOG/2006/98218
PMCID: PMC1581476  PMID: 17485817
8.  Epidemiology and Natural History of Human Papillomavirus Infections in the Female Genital Tract 
Human papillomavirus (HPV) is the most common newly diagnosed sexually transmitted infection in the United States. Although the majority of sexually active adults will be infected with HPV at least once in their lives, it is sexually active women less than 25 years of age who consistently have the highest rates of infection. Besides youth and gender, common risk factors for HPV infection and clinical sequelae of infection include high number of sexual partners and coinfection with Chlamydia trachomatis or herpes simplex virus. Most HPV infections are cleared by the immune system and do not result in clinical complications. Clinical sequelae in cases of low-risk HPV infection consist of genital warts, and clinical manifestations of high-risk HPV infection include abnormal Pap test results, low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), and cervical cancer. LSIL, HSIL, and cervical cancer carry significant morbidity and/or mortality; genital warts and abnormal Pap test results are often significant sources of psychosocial distress. Currently, there are neither effective means of preventing HPV transmission nor cures for clinical manifestations: infection can only be prevented via complete sexual abstinence, while treatment for clinical sequelae such as genital warts and cytologic abnormalities consists of removing the problematic cells and watching for recurrence; this method consumes significant health care resources and is costly. New prophylactic HPV vaccines promise to dramatically reduce the incidence of HPV infection, genital warts, and cytologic abnormalities.
doi:10.1155/IDOG/2006/40470
PMCID: PMC1581465  PMID: 16967912
9.  Does Rubella Immunity Predict Measles Immunity? A Serosurvey of Pregnant Women 
Background. This study was undertaken to determine whether rubella immunity infers measles immunity in pregnant women. Methods. Stored serum samples were obtained from the Iowa State Hygienic Laboratory for evaluation of rubella and measles immunities with IgG enzyme-linked immunosorbent assay. Results. Nine hundred serum samples were obtained for testing. The average age of the women at the time of antepartum serum collection was 28 (range, 14 to 44) years. Measles and rubella immunity were 88% and 98%, respectively; there was no effect of immunity status by age identified. Eighty eight percent of those with rubella immunity were also measles immune. There was no association between paired rubella and measles immunity identified, P < .0001. Discussion. Known rubella immunity did not infer measles immunity in our population. Thus, we recommend that pregnant women exposed to measles be tested and appropriately treated if they are found to be nonimmune.
doi:10.1155/IDOG/2006/13890
PMCID: PMC1581459  PMID: 17485795
10.  The Innate Immune System Is Activated by Stimulation of Vaginal Epithelial Cells with Staphylococcus aureus and Toxic Shock Syndrome Toxin 1  
Infection and Immunity  2005;73(4):2164-2174.
Despite knowledge of the effects of toxic shock syndrome (TSS) toxin 1 (TSST-1) on the adaptive immune system, little is known about stimulation of the innate immune system, particularly epithelial cells. This study investigated the interactions of TSS Staphylococcus aureus and TSST-1 with human vaginal epithelial cells (HVECs) and porcine mucosal surfaces. When cocultured with HVECs for 6 h, TSS S. aureus MN8 proliferated, formed aggregates on the HVEC surfaces, and produced exotoxins. Receptor binding studies showed that 35S-TSST-1 bound to 5 × 104 receptors per HVEC, with saturation at 15 min. Affymetrix Human GeneChip U133A microarray analysis determined S. aureus MNSM (100 bacteria/HVEC) caused at least twofold up- or down-regulation of 410 HVEC genes by 6 h; these data were also confirmed with S. aureus MN8. TSST-1 (100 μg/ml) caused up- or down-regulation of 2,386 HVEC genes by 6 h. In response to S. aureus, the HVEC genes most up-regulated compared to those in controls were those coding for chemokines or cytokines—MIP-3α, 478-fold; GRO-α, 26-fold; GRO-β, 14-fold; and GRO-γ, 30-fold—suggesting activation of innate immunity. TSST-1 also caused up-regulation of chemokine/cytokine genes. Chemokine/cytokine gene up-regulation was confirmed by enzyme-linked immunosorbent assays measuring the corresponding proteins induced by S. aureus and TSST-1. S. aureus MN8, when incubated with porcine vaginal tissue, increased the flux of 35S-TSST-1 across the mucosal surface. This was accompanied by influx of lymphocytes into the upper layers of the tissue. These data suggest innate immune system activation through epithelial cells, reflected in chemokine/cytokine production and influx of lymphocytes, may cause changes in vaginal mucosa permeability, facilitating TSST-1 penetration.
doi:10.1128/IAI.73.4.2164-2174.2005
PMCID: PMC1087460  PMID: 15784559
11.  Gynecologists' attitudes regarding human papilloma virus vaccination: a survey of Fellows of the American College of Obstetricians and Gynecologists. 
BACKGROUND: Human papilloma virus (HPV) is the causative agent of cervical neoplasia and genital warts. A vaccine has recently been developed that may prevent infection with HPV. Vaccination for HPV may become a routine part of office gynecology. We surveyed members of the American College of Obstetricians and Gynecologists (ACOG) to determine their attitudes to HPV vaccination. METHODS: A survey was sent to Fellows of ACOG to evaluate gynecologists' attitudes. Vaccine acceptability was analyzed using 13 scenarios with the following dimensions and respective attributes: age of patient (13, 17 and 22 years); efficacy of vaccine (50% or 80%); ACOG recommendation (yes or no); and disease targeted (cervical cancer, warts or both). Each scenario was rated by means of an 11-point response format (0 to 100). Responses were evaluated using conjoint analysis. RESULTS: Of 1200 surveys that were sent out, 181 were returned and included in our analysis. ACOG recommendation was considered the most important variable in vaccine distribution (importance score = 32.2), followed by efficacy (24.5), age (22.4) and, lastly, disease targeted (20.9). Of these variables, higher efficacy was favored; preference was given to age 17 years, with a strong disinclination to vaccinate at age 13 years; and protection against cervical cancer, or genital warts, or both, was significantly favored over a vaccine against genital warts alone. Demographic characteristics of the gynecologists (i.e., age of physician, gender, practice setting and community size) did not play an important role in the decision to recommend vaccination. CONCLUSION: Professional society recommendation is important for acceptability of a potential HPV vaccine. Gynecologists are willing to include this vaccine in their office practice.
doi:10.1080/10647440400020661
PMCID: PMC1784603  PMID: 15763912
12.  Imiquimod Does not Affect Shedding of Viable Chlamydiae in a Murine Model of Chlamydia trachomatis Genital Tract Infection 
Objective: We postulated that either oral or vaginal administration of the immune response modifier imiquimod would decrease vaginal shedding of Chlamydia trachomatis, mouse pneumonitis strain (MoPn), in a murine model.
Methods: Female BALB/c mice were infected intravaginally withC. trachomatis (MoPn) and were administered imiquimod either orally (30 mg/kg) or vaginally (10 μl of 5%imiquimod cream) prior to infection and every second day after infection for a total of four doses. The course of infection was monitored by collecting cervical–vaginal swabs and isolation in HeLa 229 cell culture. To determine whether the drug affected T helper type 1 or T helper type 2 immune response polarization, immunoglobulinG(IgG) subclass antibody responses were assessed at day 56 after infection.
Results: There was no significant difference in the course of infection when imiquimod-treated mice were compared with sham-treated controls, regardless of whether the drug was administered orally or vaginally. IgG subclass antibody responses, and by extension, T helper type 1 to T helper type 2 immune response polarization, were also unaffected.
Conclusions: Imiquimod has no efficacy in controllingC. trachomatis (MoPn) infection in the murine model.
doi:10.1080/10647440300025503
PMCID: PMC1852278  PMID: 14627213
13.  Predictors of Chlamydia trachomatis Infection Among Women Attending Rural Midwest Family Planning Clinics 
Objective: To determine predictors of Chlamydia trachomatis infection among women 14–24 years of age attending family planning clinics throughout a rural Midwestern state.
Methods: The study population included 16 756 women between the ages of 14 and 24 years attending family planning clinics for annual examinations throughout the state of Iowa in 1997. All women under 25 years of age having annual exams were tested for C. trachomatis during the visit. At the time of exam, both behavioral and demographic data were collected on all women participating in the study.
Results: The majority of women in the study (96%) reported no symptoms of chlamydia. Only 2.5% of all women had a positive test result. In the multivariate model, the odds ratios were significantly increased among the youngest age (14–17 years; OR = 2.2), those with mucopurulent cervicitis (OR = 3.4), cervical friability (OR = 2.2), symptomatic for infection (OR = 1.8), risk history (OR = 1.6), and black race (OR = 1.2) and predictive of a C. trachomatis infection.
Conclusions: Risk factors predictive of C. trachomatis infection among younger aged women attending family planning clinics in a Midwest rural population are consistent with predictors of infection among women attending family planning clinics across theUnited States. The overall findings suggest the importance of developing screening guidelines as a means of lowering chlamydia rates. This may be a particularly difficult task in light of the low rate of symptoms that would lead a woman to seek medical care, even in younger age women who are at higher risk. In addition, screening guidelines would be more difficult to implement in a rural setting.
doi:10.1155/S1064744901000023
PMCID: PMC1784629  PMID: 11368256
14.  Neisseria gonorrhoeae Elicits Membrane Ruffling and Cytoskeletal Rearrangements upon Infection of Primary Human Endocervical and Ectocervical Cells 
Infection and Immunity  2000;68(9):5354-5363.
Neisseria gonorrhoeae is a strict human pathogen that is, primarily, transmitted by close sexual contact with an infected individual. Gonococcal infection of the male urogenital tract has been well studied in experimental human models and in urethral cell culture systems. Recent studies, using tissue culture cell systems, have suggested a role for the cervical epithelium in gonococcal infection of females; however, the nature of gonococcal infection of the normal uterine cervix remains controversial. To address this enigma, we have developed two primary human cervical epithelial cell systems from surgical biopsies. Gonococcal infection studies and electron microscopy show that N. gonorrhoeae is capable of infecting and invading both the endo- and the ectocervix. Invasion was found to occur primarily in an actin-dependent manner, but it does not appear to require de novo protein synthesis by either the bacterium or the host cervical cell. Membrane ruffles appear to be induced in response to gonococci. Consistent with membrane ruffling, gonococci were found residing within macropinosomes, and a concentrated accumulation of actin-associated proteins was observed to occur in response to gonococcal infection. Electron microscopy of clinically derived cervical biopsies show that lamellipodia formation and cytoskeletal changes, suggestive of membrane ruffles, also occur in the cervical epithelium of women with naturally acquired gonococcal cervicitis. These studies demonstrate the ability of N. gonorrhoeae to infect and invade both the endo- and the ectocervix of the normal uterine cervix. Gonococcal induced ruffling is a novel finding and may be unique to the cervical epithelium.
PMCID: PMC101799  PMID: 10948165
15.  Seroreactivity to Chlamydia trachomatis Hsp10 Correlates with Severity of Human Genital Tract Disease 
Infection and Immunity  2000;68(1):303-309.
We have identified the chlamydial heat shock protein Hsp10 as a potential correlate to the immunopathogenic process in women with tubal factor infertility (TFI). The human serologic response to chlamydial Hsp10, Hsp60, and major outer membrane protein (MOMP) was measured by enzyme-linked immunosorbent assay. Three populations of women were studied: uninfected controls (CU), acutely infected (AI) women, and women with TFI. Sera from women in the AI and TFI groups both recognized Hsp10 more frequently and at a higher overall level than sera from healthy uninfected controls. Moreover, the infertile women had significantly greater Hsp10 seroreactivity than acutely infected women, indicating a concomitant increase of Hsp10 recognition in populations with increasing levels of disease severity. Hsp60 reactivity showed a similar correlation in these populations, while MOMP reactivity peaked at the same level in both AI and TFI populations but did not increase with disease severity. Test populations were standardized by level of reactivity to formalin-fixed Chlamydia trachomatis elementary bodies (EBs) to address whether these associations were reflections of increased overall chlamydial exposure rather than a property specific to Hsp10. Associations between Hsp10 seropositivity and TFI were greater in the EB+ subgroup while associations among the EB− subgroup were diminished. When restricted to the EB+ subgroups, Hsp60 and MOMP responses in the TFI population did not increase significantly over the level of AI group responses. Thus, among women with similar exposure to chlamydiae, the serologic response to Hsp10 exhibited a stronger correlation with TFI than did the response to Hsp60 or MOMP. These findings support the hypothesis that the serological response to C. trachomatis heat shock proteins is associated with the severity of disease and identifies Hsp10 as an antigen recognized by a significant proportion of women with TFI.
PMCID: PMC97135  PMID: 10603402
16.  Blindness in a Woman With Human Immunodeficiency Virus Infection and Syphilis 
Background: A concomitant infection with human immunodeficiency virus (HIV) may alter the natural history of other infections. Several reports indicate that syphilis may behave more aggressively when HIV infection is present.
Case: A woman presented with a rash involving her hands and feet and progressive loss of the vision in her right eye. Her serologic tests for syphilis and HIV infection were positive. A diagnosis of neurosyphilis was confirmed by an analysis of cerebrospinal fluid (CSF). She was treated with high-dose intravenous (IV) penicillin. Her skin lesions resolved, but her vision did not improve.
Conclusion: The incidence of HIV infection among women is rising. A patient with HIV and syphilis may develop neurosyphilis in a much shorter time than a patient without HIV infection.
doi:10.1155/S1064744995000615
PMCID: PMC2366155  PMID: 18472891
17.  Maternal and Neonatal Infection With Salmonella heidelberg : A Case Report 
Maternal and neonatal infections with Salmonella typhi have been well documented. There are only two previous case reports of intrauterine infection with non-typhoidal species. This paper presents a third case of maternal septicemia followed by neonatal sepsis with Salmonella heidelberg.
doi:10.1155/S1064744993000110
PMCID: PMC2364676  PMID: 18476206
18.  Effect of the human papillomavirus (HPV) quadrivalent vaccine in a subgroup of women with cervical and vulvar disease: retrospective pooled analysis of trial data 
Objectives To determine the effect of human papillomavirus (HPV) quadrivalent vaccine on the risk of developing subsequent disease after an excisional procedure for cervical intraepithelial neoplasia or diagnosis of genital warts, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia.
Design Retrospective analysis of data from two international, double blind, placebo controlled, randomised efficacy trials of quadrivalent HPV vaccine (protocol 013 (FUTURE I) and protocol 015 (FUTURE II)).
Setting Primary care centres and university or hospital associated health centres in 24 countries and territories around the world.
Participants Among 17 622 women aged 15–26 years who underwent 1:1 randomisation to vaccine or placebo, 2054 received cervical surgery or were diagnosed with genital warts, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia.
Intervention Three doses of quadrivalent HPV vaccine or placebo at day 1, month 2, and month 6.
Main outcome measures Incidence of HPV related disease from 60 days after treatment or diagnosis, expressed as the number of women with an end point per 100 person years at risk.
Results A total of 587 vaccine and 763 placebo recipients underwent cervical surgery. The incidence of any subsequent HPV related disease was 6.6 and 12.2 in vaccine and placebo recipients respectively (46.2% reduction (95% confidence interval 22.5% to 63.2%) with vaccination). Vaccination was associated with a significant reduction in risk of any subsequent high grade disease of the cervix by 64.9% (20.1% to 86.3%). A total of 229 vaccine recipients and 475 placebo recipients were diagnosed with genital warts, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia, and the incidence of any subsequent HPV related disease was 20.1 and 31.0 in vaccine and placebo recipients respectively (35.2% reduction (13.8% to 51.8%)).
Conclusions Previous vaccination with quadrivalent HPV vaccine among women who had surgical treatment for HPV related disease significantly reduced the incidence of subsequent HPV related disease, including high grade disease.
Trial registrations NCT00092521 and NCT00092534
doi:10.1136/bmj.e1401
PMCID: PMC3314184  PMID: 22454089

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