19 results on '"Konno, R."'
Search Results
2. Effectiveness of HPV vaccination against the development of high-grade cervical lesions in young Japanese women.
- Author
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Shiko Y, Konno R, Konishi H, Sauvaget C, Ohashi Y, and Kakizoe T
- Subjects
- Adult, Cross-Sectional Studies, Female, Humans, Immunization Programs, Incidence, Japan epidemiology, Papillomavirus Infections epidemiology, Papillomavirus Vaccines administration & dosage, Prevalence, Treatment Outcome, Uterine Cervical Neoplasms classification, Uterine Cervical Neoplasms virology, Young Adult, Uterine Cervical Dysplasia classification, Uterine Cervical Dysplasia virology, Papillomaviridae immunology, Papillomavirus Infections prevention & control, Papillomavirus Vaccines immunology, Uterine Cervical Neoplasms prevention & control, Vaccination, Uterine Cervical Dysplasia prevention & control
- Abstract
Background: Although more than 10 years have passed since HPV vaccination was implemented, first as an interim programme (Emergent vaccine promotion programme) in November 2010, followed by incorporating into the National Immunization Programme in April, 2013 and suspended in June 2013, limited studies have investigated the HPV vaccine effectiveness against high-grade cervical lesions in Japan., Methods: We collected the matched data of the results of cervical biopsy and history of vaccination from the Japan Cancer Society database. The subjects were women aged 20 to 29 years screened for cervical cancer between April, 2015 and March, 2017, and with information on HPV vaccination status. We estimated the relative risk of developing high-grade cervical lesions in vaccinated subjects using Poisson regression as compared to unvaccinated subjects., Results: Among the 34,281 women screened, 3770 (11.0%) were vaccinated. The prevalence of CIN2+ was statistically significantly lower in the vaccinated women as compared to the unvaccinated women (Vaccine Effectiveness (VE) =76%; RR = 0.24, 95% CI:0.10-0.60). High VE against CIN3+ was also observed (91%; RR = 0.09, 95% CI:0.00-0.42)., Conclusion: Women aged 20-29 years who received at least one dose of HPV vaccine had a significantly lower risk of high-grade cervical lesions than those not vaccinated. In Japan, HPV vaccination should be resumed in order to reduce the incidence of cervical cancer.
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- 2020
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3. Effectiveness of HPV vaccination against high grade cervical lesions in Japan.
- Author
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Konno R, Konishi H, Sauvaget C, Ohashi Y, and Kakizoe T
- Subjects
- Adult, Cohort Studies, Female, Humans, Japan, Mass Screening, Regression Analysis, Uterine Cervical Neoplasms diagnosis, Vaccine Potency, Young Adult, Uterine Cervical Dysplasia diagnosis, Papillomavirus Infections prevention & control, Papillomavirus Vaccines therapeutic use, Uterine Cervical Neoplasms prevention & control, Vaccination statistics & numerical data, Uterine Cervical Dysplasia prevention & control
- Abstract
The effectiveness of HPV vaccine against HSIL+ (pathologically diagnosed CIN2+) in the first cohort in Japan was investigated in 22,743 women aged 20 to 29 years (parts of national cervical cancer screening program of FY [fiscal year] 2015, the Japan Cancer Society). Vaccinated women had a statistically significant 69% lower risk of HSIL+ as compared to the unvaccinated women; the crude relative risk estimate was 0.31 (95% CI: 0.11-0.83; p-value = 0.013) by normal approximation and 0.31 (95% CI: 0.08-0.80; p-value = 0.009) by the exact Poisson regression. The effect of age was not significant (chisq = 7.7 (df = 9), p-value = 0.569) and the estimate of relative risk remained essentially intact after adjustment for age. This study brings scientific evidence on the effectiveness of HPV vaccine on development of cervical high grade lesions., (Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2018
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4. Human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for the prevention of cervical cancer and HPV-related diseases.
- Author
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Skinner SR, Apter D, De Carvalho N, Harper DM, Konno R, Paavonen J, Romanowski B, Roteli-Martins C, Burlet N, Mihalyi A, and Struyf F
- Subjects
- Anus Neoplasms epidemiology, Anus Neoplasms prevention & control, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Condylomata Acuminata epidemiology, Condylomata Acuminata prevention & control, Female, Humans, Lipid A administration & dosage, Mouth Neoplasms epidemiology, Mouth Neoplasms prevention & control, Papillomavirus Infections complications, Papillomavirus Infections epidemiology, Papillomavirus Vaccines administration & dosage, Randomized Controlled Trials as Topic, Adjuvants, Immunologic administration & dosage, Aluminum Hydroxide administration & dosage, Human papillomavirus 16 immunology, Human papillomavirus 18 immunology, Lipid A analogs & derivatives, Papillomavirus Infections prevention & control, Papillomavirus Vaccines immunology, Uterine Cervical Neoplasms prevention & control
- Abstract
Vaccines are available against human papillomavirus (HPV), the causal agent of cervical and other cancers. Efficacy data from the HPV-16/18 AS04-adjuvanted vaccine clinical trial program were reviewed. Six randomized, controlled phase II/III trials evaluating cervical endpoints enrolled women from diverse populations and geographical locations. The program analyzed extensively the cohorts most relevant from a public health perspective: the total vaccinated cohort (TVC), approximating a general population including those with existing or previous HPV infection, and TVC-naïve, approximating a population of young women before sexual debut. Results show that the vaccine reduces HPV-16/18 infection and associated cervical endpoints in women regardless of age, location, or sexual experience. It provides cross-protection against some non-vaccine oncogenic HPV types and types causing genital warts, and may be effective against vulvar, oral, and anal HPV infection. Early epidemiology data following its introduction suggest a decline in the prevalence of vaccine and some non-vaccine HPV types.
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- 2016
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5. Human Papillomavirus (HPV) Vaccination: Just the Facts.
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Castle P, Konno R, and Bosch X
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- Female, Humans, Autonomic Nervous System Diseases chemically induced, Immunization adverse effects, Papillomavirus Infections prevention & control, Papillomavirus Vaccines adverse effects, Sympathetic Nervous System physiopathology
- Published
- 2015
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6. An exploratory study of Japanese fathers' knowledge of and attitudes towards HPV and HPV vaccination: does marital status matter?
- Author
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Hanley SJ, Yoshioka E, Ito Y, Konno R, Sasaki Y, Kishi R, and Sakuragi N
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- Adolescent, Adult, Child, Fathers, Female, Humans, Japan epidemiology, Male, Marital Status, Middle Aged, Nuclear Family, Sexual Behavior, Surveys and Questionnaires, Uterine Cervical Neoplasms epidemiology, Uterine Cervical Neoplasms virology, Vaccination, Health Knowledge, Attitudes, Practice, Papillomavirus Infections prevention & control, Papillomavirus Vaccines therapeutic use, Patient Acceptance of Health Care, Uterine Cervical Neoplasms prevention & control
- Abstract
Background: No studies on male attitudes towards HPV and HPV vaccination have been conducted in Japan, and little is known globally whether attitudes of single fathers differ to those living with a female partner. This exploratory study assessed whether Japanese fathers were likely to have their daughter vaccinated against HPV in a publically funded program and whether any differences existed regarding attitudes and knowledge about HPV according to marital status., Materials and Methods: Subjects were 27 fathers (16 single; 11 married) who took part in a study on HPV vaccine acceptability aimed at primary caregivers of girls aged 11-14 yrs in three Japanese cities between July and December 2010., Results: Knowledge about HPV was extremely poor (mean score out of 13 being 2.74 ± 3.22) with only one (3.7%) participant believing he had been infected with HPV and most (81.4%) believing they had no or low future risk. No difference existed regarding knowledge or awareness of HPV according to marital status. Concerning perceived risk for daughters, single fathers were significantly more likely to believe their daughter was at risk for both HPV (87.5% versus 36.4%; p=0.01) and cervical cancer (75.0% versus 27.3%; p=0.02). Acceptability of free HPV vaccination was high at 92% with no difference according to marital status, however single fathers were significantly more likely (p=0.01) to pay when vaccination came at a cost. Concerns specific to single fathers included explaining the sexual nature of HPV and taking a daughter to a gynecologist to be vaccinated., Conclusions: Knowledge about HPV among Japanese fathers is poor, but HPV vaccine acceptability is high and does not differ by marital status. Providing sexual health education in schools that addresses lack of knowledge about HPV as well as information preferences expressed by single fathers, may not only increase HPV vaccine acceptance, but also actively involve men in cervical cancer prevention strategies. However, further large-scale quantitative studies are needed.
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- 2014
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7. Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical intraepithelial neoplasia and cervical infection in young Japanese women.
- Author
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Konno R, Yoshikawa H, Okutani M, Quint W, V Suryakiran P, Lin L, and Struyf F
- Subjects
- Adolescent, Adult, Antibodies, Viral blood, Female, Follow-Up Studies, Human papillomavirus 16 immunology, Human papillomavirus 18 immunology, Humans, Japan, Lipid A administration & dosage, Papillomavirus Infections immunology, Papillomavirus Vaccines administration & dosage, Randomized Controlled Trials as Topic, Time Factors, Treatment Outcome, Young Adult, Uterine Cervical Dysplasia immunology, Aluminum Hydroxide administration & dosage, Lipid A analogs & derivatives, Papillomavirus Infections prevention & control, Papillomavirus Vaccines immunology, Uterine Cervical Dysplasia prevention & control
- Abstract
In this open, extended follow-up study (NCT00929526, Clinicaltrials.gov), we evaluated the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine efficacy, immunogenicity and safety up to 4 years after first vaccination in Japanese women aged 20-25 years. In the initial randomized, double-blind study (NCT00316693), 1040 women received the study vaccine or hepatitis A control vaccine; 752 women were included in the follow-up study. In women from the according-to-protocol efficacy cohort (ATP-E), who were initially seronegative for the HPV type analyzed, no cervical intraepithelial neoplasia (CIN) grade 1 or greater (CIN1+) cases associated with HPV-16/18 were reported in the HPV group, while in the control group, 5 cases were identified in extended follow-up analyses (vaccine efficacy [VE] 100% [95% CI: -3.7-100]) and 8 cases in combined initial and follow-up studies analyses (VE 100% [42.2-100]). In the ATP-E, VE against CIN1+ and CIN2+ associated with high-risk HPV types reached 66.4% (21.6-87.1) and 83.0% (22.1-98.2) in extended follow-up analyses, and 63.4% (28.8-82.3) and 77.3% (30.4-94.4) in analyses of combined studies, respectively. During the 4-year period, protection against CIN1+ and CIN2+, irrespective of the HPV type, was 56.7% (32.8-72.6) and 54.9% (20.5-75.3) in women receiving ≥1 vaccine dose, regardless of baseline serostatus (total vaccinated cohort [TVC]) and 61.0% (11.8-84.2) and 73.9% (1.1-95.3) in women naïve to HPV infection at baseline (TVC-naïve), respectively. The high VE observed in Japanese women, accompanied by a sustained immune response and a clinically acceptable safety profile, support findings of large, international trials.
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- 2014
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8. [I. Screening of uterine cervical neoplasms and HPV vaccine].
- Author
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Konno R
- Subjects
- Clinical Trials as Topic, Female, Humans, Infertility, Female etiology, Uterine Cervical Neoplasms therapy, Early Detection of Cancer, Papillomavirus Vaccines therapeutic use, Uterine Cervical Neoplasms diagnosis, Uterine Cervical Neoplasms prevention & control
- Published
- 2013
9. Acceptance of and attitudes towards human papillomavirus vaccination in Japanese mothers of adolescent girls.
- Author
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Hanley SJ, Yoshioka E, Ito Y, Konno R, Hayashi Y, Kishi R, and Sakuragi N
- Subjects
- Adolescent, Adult, Asian People, Child, Demography, Female, Humans, Japan, Middle Aged, Papillomavirus Infections prevention & control, Surveys and Questionnaires, Vaccination economics, Health Knowledge, Attitudes, Practice, Mothers psychology, Papillomavirus Vaccines economics, Patient Acceptance of Health Care statistics & numerical data, Vaccination psychology
- Abstract
To better understand how to achieve high uptake rates of human papillomavirus (HPV) vaccination in Japan, we investigated acceptance of and attitudes towards HPV vaccination in 2192 mothers of girls aged 11-14 yrs. A school-based survey was conducted in five elementary and fourteen junior high schools in Sapporo, Japan. Responses from 862 participants were analyzed. Ninety-three percent of mothers would accept the vaccine for their daughter if free, but only 1.5% was willing to pay the minimum recommended price of ¥ 40,000. Vaccine acceptance was higher in mothers who had heard of HPV vaccine (adjusted odds ratio, aOR=2.58, confidence interval, CI=1.47-4.53), and who believed susceptibility to (aOR=2.30, CI=1.34-3.92) and severity of (aOR=3.73, CI=1.41-9.88) HPV to be high. Recommendations from a doctor (aOR=12.60, CI=7.06-21.48) and local health board (aOR=27.80, CI=13.88-55.86) were also positively associated with increased HPV vaccine acceptance. Concerns about side effects of both the HPV vaccine (aOR=0.03, CI=0.01-0.08) and routine childhood vaccines in general (aOR=0.11, CI=0.02-0.78) emerged as barriers to vaccination. Not participating in routine cervical screening also emerged as a deterrent (aOR=0.49, CI=0.27-0.91). While most mothers (66.8%) agreed that 10-14 yr was an appropriate age for vaccination, a further 30.6% believed >15 yr to be more appropriate. In conclusion, attitudes of Japanese mothers toward HPV vaccination are encouraging. While lower vaccine acceptance in mothers who do not undergo regular cervical screening needs further investigation, this study indicates that high uptake may be possible in a publically funded HPV vaccination program if physicians actively address safety concerns and justify why the vaccine is needed at a particular age., (Copyright © 2012 Elsevier Ltd. All rights reserved.)
- Published
- 2012
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10. High HPV vaccination uptake rates for adolescent girls after regional governmental funding in Shiki City, Japan.
- Author
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Hayashi Y, Shimizu Y, Netsu S, Hanley S, and Konno R
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- Adolescent, Child, Female, Humans, Immunization Schedule, Japan, Patient Acceptance of Health Care, Program Evaluation, Vaccination economics, Papillomavirus Infections prevention & control, Papillomavirus Vaccines administration & dosage, Vaccination statistics & numerical data
- Abstract
Background: In Japan, the bivalent HPV vaccine was approved in October, 2009 and became available as a non-routine vaccine from December, 2009. While routine vaccinations are free, the cost and responsibility for non-routine vaccinations are left to the individual. In exceptional circumstances regional governments fund non-routine vaccinations. This was the case in Shiki City, Saitama Prefecture, where a high uptake rate for individual (non-school based) HPV vaccination was obtained., Materials: On January 20, 2010, the mayor of Shiki City announced to the media his decision to vaccinate adolescent girls in Shiki City against HPV. A project team for HPV vaccination was set up in the city's Health Promotion Center. To gain mutual consent for HPV vaccination, senior health professionals, city officials, the head of the board of education, school principals and health-care teachers met several times. The cohort to be vaccinated was 1254 girls aged 12-15 years. Individual notifications were mailed to each girl on April 23, 2010, along with information about the HPV vaccine., Conclusions: As of April 10th, 2011, the uptake rate for girls aged 15 years old was 90.7% for the 1st dose. The vaccine registry is managed by the health care system of the city. The success of the HPV vaccination program and high uptake rates in Shiki City is a good model for the nationwide HPV vaccination program that started in February, 2011., (Copyright © 2012 Elsevier Ltd. All rights reserved.)
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- 2012
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11. [HPV (human papillomavirus) vaccine].
- Author
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Konno R
- Subjects
- Adolescent, Adult, Female, Humans, Papillomavirus Infections prevention & control, Papillomavirus Vaccines, Uterine Cervical Neoplasms prevention & control
- Published
- 2012
12. [Human papillomavirus vaccination for prevention of cervical cancer].
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Hayashi Y, Mitsushita J, Netsu S, and Konno R
- Subjects
- Adolescent, Female, Humans, Vaccination, Papillomavirus Vaccines, Uterine Cervical Neoplasms prevention & control
- Abstract
Persistent infection of human papillomavirus (HPV) is the necessary cause for developing cervical cancer. Now cervical cancer is getting attention as not only early-detectable but also preventable cancer by developing vaccine for HPV. In Japan, the first HPV vaccine, "Cervarix, GlaxoSmithKline (GSK)" was licensed on October 2009 and vaccination was started on December 2009. This is the bivalent vaccine specifically targeting HPV-16 and -18 types. Domestic clinical trial is also about to demonstrate the efficacy, safety, and possibility to keep enough antibody levels. The widespread use of this vaccine will help cervical cancer eliminated.
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- 2011
13. Prevalence and type distribution of human papillomavirus in healthy Japanese women aged 20 to 25 years old enrolled in a clinical study.
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Konno R, Tamura S, Dobbelaere K, and Yoshikawa H
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- Adult, Cervix Uteri pathology, DNA, Viral genetics, Double-Blind Method, Female, Humans, Papillomaviridae genetics, Papillomavirus Infections prevention & control, Papillomavirus Infections virology, Polymerase Chain Reaction, Prevalence, Survival Rate, Treatment Outcome, Uterine Cervical Dysplasia prevention & control, Uterine Cervical Dysplasia virology, Uterine Cervical Neoplasms prevention & control, Uterine Cervical Neoplasms virology, Vaccination, Vaginal Smears, Women's Health, Young Adult, Papillomaviridae classification, Papillomavirus Infections epidemiology, Papillomavirus Vaccines therapeutic use, Uterine Cervical Dysplasia epidemiology, Uterine Cervical Neoplasms epidemiology
- Abstract
Efficacy, immunogenicity and tolerability of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine were evaluated in Japanese women aged 20-25 years, for which results have been reported previously. We analyzed the baseline data from that study and report the prevalence rates of HPV infection in young healthy Japanese women. One thousand and the forty Japanese women aged 20-25 years were enrolled in a phase II, double-blind, controlled, randomized, multicenter study. At study entry, cervical specimens were collected from the women and tested by line probe assay for 25 HPV-types and by HPV-16/18-specific polymerase chain reaction. The most frequently detected HPV-type in baseline cervical specimens was HPV-52 (8.1%), followed by HPV-16 (6.5%), HPV-51 (4.5%), HPV-18 (4.0%) and HPV-31 (3.8%). The proportion of HPV DNA-positive women increased with severity of cytological abnormalities: 26.1% (237/908) in normal cytology, 93.3% (70/75) in low-grade squamous intraepithelial lesion and 100% (7/7) in high-grade squamous intraepithelial lesion. The relative contribution of HPV-16 and HPV-18 was 4.1 and 3.0% for normal cytology cases, and 20.0 and 16.0% in low-grade squamous intraepithelial lesion, respectively. HPV-16 was found in four of seven high-grade squamous intraepithelial lesion cases (57.1%) and five of the six cervical intraepithelial neoplasia 2+ cases (83.3%). Multiple and single HPV infections were observed in 13.5% (140/1039) and 20.7% (215/1039) of all women, respectively. The HPV prevalence rates in Japanese women aged 20-25 years underline the importance of HPV vaccination at a young age and this report should be useful for monitoring changes in HPV prevalence after widespread HPV vaccination in Japanese women., (© 2011 Japanese Cancer Association and GlaxoSmithKline Biologicals.)
- Published
- 2011
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14. Efficacy of human papillomavirus 16/18 AS04-adjuvanted vaccine in Japanese women aged 20 to 25 years: interim analysis of a phase 2 double-blind, randomized, controlled trial.
- Author
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Konno R, Tamura S, Dobbelaere K, and Yoshikawa H
- Subjects
- Adult, Asian People, Double-Blind Method, Female, Follow-Up Studies, Humans, Neoplasm Staging, Papillomavirus Infections pathology, Papillomavirus Infections virology, Survival Rate, Treatment Outcome, Uterine Cervical Neoplasms pathology, Uterine Cervical Neoplasms virology, Vaginal Smears, Young Adult, Uterine Cervical Dysplasia pathology, Uterine Cervical Dysplasia virology, Human papillomavirus 16 isolation & purification, Human papillomavirus 18 isolation & purification, Papillomavirus Infections prevention & control, Papillomavirus Vaccines administration & dosage, Uterine Cervical Neoplasms prevention & control, Uterine Cervical Dysplasia prevention & control
- Abstract
Background: A phase 2 double-blind, controlled, randomized multicenter study with human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine is ongoing in healthy Japanese women aged 20 to 25 years. We assessed the vaccine efficacy in the event-triggered analysis., Methods: Japanese women aged 20 to 25 years were randomly assigned to receive either HPV-16/18 AS04-adjuvanted (n = 519) or hepatitis A (n = 521) vaccine at 0, 1, and 6 months. The women were assessed for virological and cytological end points associated with HPV-16/18 in cervical specimens and for the vaccine safety and immunogenicity., Results: The mean length of follow-up for women in the primary analysis for efficacy at the time of a prespecified event-triggered interim analysis was 13.6 months after the first vaccination. Vaccine efficacy against HPV-16/18 persistent infections (6-month definition) in the according-to-protocol cohort for efficacy was 100% (99% confidence interval, 20.5-100, P = 0.0037). At 6 months after the third dose of vaccine, geometric mean titers against HPV-16 and HPV-18 were 2899.3 and 1352.2 enzyme-linked immunosorbent assay units per milliliter, respectively, that is, 97- and 60-fold higher than geometric mean titers observed after natural infection. There were no clinically meaningful differences in safety between the HPV and control group., Conclusions: The HPV-16/18 AS04-adjuvanted vaccine was as efficacious in Japan as in other countries and was generally safe and highly immunogenic in Japanese women.
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- 2010
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15. Cost-effectiveness analysis of prophylactic cervical cancer vaccination in Japanese women.
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Konno R, Sasagawa T, Fukuda T, Van Kriekinge G, and Demarteau N
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- Adult, Asian People, Cohort Studies, Cost-Benefit Analysis, Female, Human papillomavirus 16 isolation & purification, Humans, Middle Aged, Models, Economic, Neoplasm Staging, Papillomavirus Infections complications, Papillomavirus Infections prevention & control, Papillomavirus Vaccines administration & dosage, Quality-Adjusted Life Years, Sensitivity and Specificity, Survival Rate, Treatment Outcome, Uterine Cervical Neoplasms prevention & control, Uterine Cervical Neoplasms virology, Young Adult, Uterine Cervical Dysplasia prevention & control, Uterine Cervical Dysplasia virology, Papillomavirus Infections economics, Papillomavirus Vaccines economics, Uterine Cervical Neoplasms economics, Vaccination economics, Vaginal Smears economics, Uterine Cervical Dysplasia economics
- Abstract
Introduction: The incidence of cervical cancer (CC) is high in Japan and is further increasing among women younger than 30 years. This burden could be reduced by the implementation of a CC vaccine, but its cost-effectiveness is unknown., Methods: We quantified the clinical impact and assessed the cost-effectiveness of adding CC vaccination at age 12 to the current screening in place in Japan with a lifetime Markov model adapted to the Japanese setting. Transition probabilities and utility values were obtained from public databases. Direct costs for treatment and screening were estimated using Japanese medical fees. Annual costs and benefits were discounted at 3%. Sensitivity analyses were conducted on the age at vaccination, the vaccine characteristics, the discount rates, the proportion of human papillomavirus types 16/18 in cancer, and the screening coverage., Results: Vaccinating a 12-year-old cohort was predicted to reduce CC incidence and deaths from CC by 73%. These clinical effects were associated with an incremental cost-effectiveness ratio of yen1.8 million per quality-adjusted life year gained. The incremental cost-effectiveness ratio of vaccinating all 10- to 45-year-old women was yen2.8 million per quality-adjusted life year, still below the threshold value., Conclusions: The implementation of a CC vaccination in Japan could reduce the CC burden in a very cost-effective manner for women up to 45 years.
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- 2010
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16. [Prevention of cervical cancer by HPV vaccine].
- Author
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Konno R
- Subjects
- Cancer Vaccines immunology, Clinical Trials as Topic, Female, Humans, Papillomavirus Infections complications, Uterine Cervical Neoplasms etiology, Uterine Cervical Neoplasms virology, Papillomavirus Infections immunology, Papillomavirus Infections prevention & control, Papillomavirus Vaccines immunology, Uterine Cervical Neoplasms immunology, Uterine Cervical Neoplasms prevention & control
- Published
- 2010
17. Immunogenicity, reactogenicity, and safety of human papillomavirus 16/18 AS04-adjuvanted vaccine in Japanese women: interim analysis of a phase II, double-blind, randomized controlled trial at month 7.
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Konno R, Dobbelaere KO, Godeaux OO, Tamura S, and Yoshikawa H
- Subjects
- Adjuvants, Immunologic, Adult, Antibodies, Viral blood, Cohort Studies, DNA, Viral analysis, Double-Blind Method, Enzyme-Linked Immunosorbent Assay, Female, Human papillomavirus 16 genetics, Human papillomavirus 18 genetics, Humans, Japan, Papillomavirus Infections immunology, Papillomavirus Infections virology, Papillomavirus Vaccines administration & dosage, Papillomavirus Vaccines adverse effects, Polymerase Chain Reaction, Uterine Cervical Neoplasms immunology, Uterine Cervical Neoplasms virology, Young Adult, Human papillomavirus 16 immunology, Human papillomavirus 18 immunology, Papillomavirus Infections prevention & control, Papillomavirus Vaccines immunology, Uterine Cervical Neoplasms prevention & control
- Abstract
A phase II, double-blind, controlled randomized multicenter study with human papillomavirus (HPV) 16/18 AS04 (3-O-desacyl-4'-monophosphoryl lipid A and aluminum hydroxide)-adjuvanted vaccine is ongoing in Japanese women aged 20 to 25 years. An interim analysis was performed at month 7 (1 month after the third dose of vaccine) to determine reactogenicity, safety, and immunogenicity of the vaccine and to evaluate the baseline HPV-16/18 seropositivity and DNA status of women. In the HPV-16/18 group (according-to-protocol cohort for immunogenicity analysis), 100% seroconversion was observed against HPV-16 and HPV-18 at month 6 (5 months after the second dose) and at month 7. At month 7, anti-HPV-16 geometric mean titer (GMT) was 7441.0 enzyme-linked immunosorbent assay units/mL and anti-HPV-18 GMT was 3805.4 enzyme-linked immunosorbent assay units/mL, which is, respectively, 250- and 168-fold higher than GMTs observed after natural infection with HPV-16 or HPV-18. In the total vaccinated cohort, the seropositivity rates against HPV-16 and HPV-18 at study entry were 17.3% and 15.8%, respectively. At the same time point, HPV-16 and HPV-18 DNA was detected in 6.5% and 4.0% of the women, respectively. The immunogenicity of the HPV-16/18 vaccine and the HPV prevalence before vaccination in Japanese women are in line with what was observed in other populations. Injection site symptoms and some general symptoms were reported more frequently in the HPV-16/18 group than in the hepatitis A vaccine group but had no impact on compliance with completion of the vaccination course. Overall, the HPV-16/18 vaccine had a good safety profile, was well tolerated, and is highly immunogenic in the study population of Japanese women.
- Published
- 2009
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18. The need for public education on HPV and cervical cancer prevention in Asia. Opinions of experts at the AOGIN conference.
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Garland S, Park SN, Ngan HY, Frazer I, Tay EH, Chen CJ, Bhatla N, Pitts M, Shin HR, Konno R, Smith J, Pagliusi S, and Park JS
- Subjects
- Adolescent, Asia, Child, Female, Humans, Mass Vaccination, Schools, Uterine Cervical Neoplasms diagnosis, Vaginal Smears, Young Adult, Health Education, Papillomavirus Vaccines therapeutic use, Uterine Cervical Neoplasms prevention & control
- Abstract
Asia accounts for more than half of all cases of cervical cancer registered globally and improving prevention is urgently needed. A range of tools and strategies is now available to effectively prevent this disease, including two new prophylactic HPV vaccines approved and recommended for adolescents and young women. However, without communication these tools may have little impact on disease burden. The conferences of the Asia Oceania Research Organisation in Genital Infection and Neoplasia (AOGIN) bring together clinicians and scientists whose work is related to genital infections, particularly HPV, cervical dysplasia and neoplasia, as well as other anogenital cancers, with the aim of improving communication on prevention through human papillomavirus (HPV) vaccination and screening in Asian countries. The scope of this year's AOGIN conference was to extend education to include health workers, family doctors, paediatricians, governmental health agencies, and the general public through patients' testimonials that can reach out to women raising awareness of this silent disease. Community based initiatives and awareness campaigns were also reported, and can empower the people to engage in a dialog with local governments towards prioritization of cancer prevention programs, achieving more for the public than isolated actions. Parents and teachers are encouraged to communicate about these issues within families and schools. Evidence was discussed that males can participate in cervical cancer control as well, and prevention programs involving men should not be neglected as they may reduce genital disease burden in women. Opinion leaders proposed prevention measures to be considered for governmental decisions. While each country develops a locally appropriate policy for cervical cancer control there is a need to revise these programs regularly, as knowledge increases in response to public need, as well as to gather evidence about disease burden and the effectiveness of education and interventions. In conclusion, AOGIN is committed to improve communication with patients, health authorities, professional organizations and opinion leaders towards strengthening cervical cancer prevention in Asia, to achieve a timely steep reduction in this cancer.
- Published
- 2008
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19. Recommendations for cervical cancer prevention in Asia Pacific.
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Garland SM, Cuzick J, Domingo EJ, Goldie SJ, Kim YT, Konno R, Parkin DM, Qiao YL, Sankaranarayanan R, Stern PL, Tay SK, and Bosch FX
- Subjects
- Adolescent, Adult, Aged, Alphapapillomavirus classification, Alphapapillomavirus isolation & purification, Asia epidemiology, Cost-Benefit Analysis, Female, Humans, Immunization Programs, Male, Mass Screening, Middle Aged, Pacific Islands epidemiology, Papillomavirus Infections complications, Papillomavirus Infections epidemiology, Papillomavirus Vaccines economics, Papillomavirus Vaccines standards, Prevalence, Risk Factors, Treatment Outcome, Uterine Cervical Neoplasms epidemiology, Uterine Cervical Neoplasms etiology, Vaccination economics, Vaccination standards, Vaginal Smears, Young Adult, Health Planning Guidelines, Papillomavirus Infections prevention & control, Papillomavirus Vaccines therapeutic use, Uterine Cervical Neoplasms prevention & control
- Abstract
Asia Oceania includes countries from both the Asia Pacific region and Australasia, which cover very diverse geographical areas and populations as well as bearing 52% of the cervical cancer burden in the world. Human papillomavirus (HPV) genotype distribution in women with normal cytology varies between countries in this region, as well as with the distribution typically observed in worldwide estimates or in Western countries. HPV-16 remains the predominant oncogenic type for high-grade cervical dysplasia and cervical cancer across the region, and HPV-18 is generally among the five most common types. HPV-58 is commonly found in cervical cancer as well as in women with normal cytology, and HPV-31, 33 and 35 are relatively less frequent in these regions compared to the West. While screening programmes have been proposed and implemented in several populations, successful programmes are rather limited and the majority of countries still have no or minimal screening services. Prophylactic HPV vaccination will only be feasible when it becomes affordable, thus the current priority and the short-term goal for cervical cancer control is to identify feasible and effective screening measures, and to find the most effective way to combine vaccination with sustainable screening programmes. This Regional Report has carefully described the disease burden of HPV and cervical cancer and the current situations in cervical cancer prevention for many countries in the Asia Oceania region. These data identify the many challenges and opportunities to be considered for policy decisions for cervical cancer control. Furthermore, this report presents the results of advanced decision analytic models calibrated to countries in the region that provide early insight into what strategies are most promising and those likely to be cost-effective and affordable. It thus provides a synthesis of the available evidence-based scientific information, in the context of a significant and systematic international review, that is likely to be useful to governments and public health providers.
- Published
- 2008
- Full Text
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