Efficacy of Human Papillomavirus 16 and 18 (HPV-16/18) AS04-Adjuvanted Vaccine against Cervical Infection and Precancer in Young Women: Final Event-Driven Analysis of the Randomized, Double-Blind PATRICIA Trial

Apter, Dan; Wheeler, Cosette M.; Paavonen, Jorma; Castellsagué, Xavier; Garland, Suzanne M.; Skinner, S. Rachel; Naud, Paulo; Salmerón, Jorge; Chow, Song‐Nan; Kitchener, Henry C; Teixeira, Júlio César; Jaisamrarn, Unnop; Limson, Genara; Szarewski, Anne; Romanowski, Barbara; Aoki, Fred Y.; Schwarz, Tino F.; Poppe, Willy; Bosch, F. Xavier; Mindel, Adrian; Sutter, Philippe De; Hardt, Karin; Zahaf, Toufik; Descamps, Dominique; Struyf, Frank; Lehtinen, Matti; Dubin, Gary

doi:10.1128/cvi.00591-14

Cited by 97 publications

(79 citation statements)

References 41 publications

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“…In other clinical trials and surveillance studies conducted in different countries such as Japan, the Netherlands and United Kingdom7, 8, 9, 10, 11, 12, 13, 14, 15, 24, 25, 26, 27, 28, 29, transient injection‐site pain lasting for less than 5 days 30 was consistently the most commonly occurring AE. The results of the present study now provide further evidence that the safety profile of the HPV‐16/18 AS04‐adjuvanted vaccine is similar when administered to women in Korea.…”

Section: Discussionmentioning

confidence: 83%

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Six‐year multi‐centre, observational, post‐marketing surveillance of the safety of the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 10–25 years in Korea

Kim

Song²,

Chen

et al. 2017

Pharmacoepidemiology and Drug

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PurposeTo evaluate the safety of HPV‐16/18 AS04‐adjuvanted vaccine when administered as per the PI in Korea.MethodsA total of 3084 women aged 10–25 years were enrolled in this post‐marketing surveillance from 2008 to 2014. Subjects were invited to receive three doses of the vaccine (0, 1 and 6 months), and participants who received at least one dose were included in the analysis. Adverse events (AEs), adverse drug reactions (ADRs) and serious AEs (SAEs) were recorded after each dose. All AEs, ADRs and SAEs were presented with exact 95% confidence intervals (CI) (NCT01101542).ResultsInjection‐site pain was the most frequent AE and ADR reported by 322 subjects (10.4% [95%CI: 9.4–11.6]); the local pain was transient and lasted 4–7 days in most cases. Dysmenorrhoea and vaginitis were the most common unexpected AEs reported by 30 (1.0% [95%CI: 0.7–1.4]) and 16 subjects (0.7% [95%CI: 0.3–0.8]), respectively. Pain (toe pain, leg pain and body pain [one case each]; foot pain [two cases]) was the most common unexpected ADR reported by five subjects (0.2% [95%CI: 0.1–0.4]). Four subjects reported a single SAE (one case each of exostosis, gastroenteritis, abortion and tonsillitis); none were fatal. All SAEs were assessed as unlikely to be related to vaccination; gastroenteritis, exostosis and tonsillitis resolved during the study period.ConclusionsThis is the first post‐marketing surveillance study in Korea that provides 6‐year safety data for HPV‐16/18 AS04‐adjuvanted vaccine. The vaccine showed an acceptable safety profile and favourable benefit/risk ratio when given to women aged 10–25 years in Korea. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.

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Section: Discussionmentioning

confidence: 83%

“…The vaccine has been shown to be efficacious in preventing 93.2% of high grade cervical intraepithelial neoplasia (CIN3+) in naive population with an acceptable safety profile and sustained immunogenicity 7, 8, 9, 10, 11. Post‐licensure surveillance has confirmed the safety profiles of the vaccine in many populations 12, 13, 14, 15.…”

Section: Introductionmentioning

confidence: 99%

Six‐year multi‐centre, observational, post‐marketing surveillance of the safety of the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 10–25 years in Korea

Kim

Song²,

Chen

et al. 2017

Pharmacoepidemiology and Drug

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“…Recent data indicates that immune responses to the vaccine are greater when initiated before adolescence [34,35]. In addition, HPV antibody titers measured after HPV vaccination in women aged 16-26 years have been shown to be lower than those in younger women [36][37][38][39]. While we did not ascertain prior HPV exposure (eg, by serological analysis) for subjects who entered the study having received at least 1 dose, the associations between the age at vaccination and risk of anogenital HPV6/11/16/18 infection and cervical cytological abnormalities did not appear to be due to differences in sexual experience at time of vaccination.…”

Section: Discussionmentioning

confidence: 99%

Risk of Delayed Human Papillomavirus Vaccination in Inner-City Adolescent Women

et al. 2016

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Background. Uptake of human papillomavirus (HPV) vaccine in the United States is slow, and the effectiveness of the vaccine has not been assessed in high-risk adolescent populations.Methods. We conducted a longitudinal study of 1139 sexually active, inner-city adolescent women receiving the 3-dose quadrivalent (4vHPV) vaccine. Cervical and anal specimens collected semiannually were tested using an L1-specific polymerase chain reaction assay. Postvaccination incidence of 4vHPV vaccine and nonvaccine HPV types, and risk of cervical cytological abnormalities, were assessed in relation to time to completion of all 3 vaccine doses.Results. Compared to vaccine naive women at enrollment, vaccinated women had significantly lower incidence rate ratios of cervical infection with HPV6/11/16/18 (0.2; 95% confidence interval [CI], .1-.4) and the related types HPV31 and HPV45 (0.4 [95% CI, .2-1.0] and 0.3 [95% CI, .1-.6], respectively), as well as significantly lower incidence rate ratios of anal infection with HPV6/11/16/18 (0.4; 95% CI, .2-.7). Notably, we observed higher risks of cervical HPV6/11/16/18 infection (hazards ratio [HR], 2.9; 95% CI, 1.0-8.0) and associated cytological abnormalities (HR, 4.5; 95% CI, .7-26.0) among women immunized at ≥15 years of age who took ≥12 months (vs <12 months) to complete the 3-dose regimen.Conclusions. Among adolescents immunized at ≥15 years of age, a longer time to complete the 3-dose schedule was associated with an increased risk of anogenital HPV6/11/16/18 infection and an increased incidence of associated cervical cytological abnormalities.

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“…Vaccinating girls between the ages of 14 and 19 has been found to reduce the prevalence of vaccine type HPV infection (HPV type 6,11,16,18) 18 Vaccinating 12-year-old girls (70% coverage) with bivalent /quadrivalent vaccines is predicted to reduce Cervical Intraepithelial Neoplasia (CIN) 2 and 3, cervical squamous cell carcinoma and anogenital warts substantially over 70 years. The nonavalent vaccine may further reduce precancerous lesions and cervical malignancy.…”

Section: Self-protectionmentioning

confidence: 99%

“…HPV vaccine has shown to be effective in decreasing the incidence of premalignant lesions by 70 to 90%. 15,16 Advisory Committee on Immunisation Practices (ACIP) recommends routine vaccination with HPV4 or HPV2 for females aged 11 or 12 years and with HPV4 for males aged 11 or 12 years. For those who were not vaccinated earlier, ACIP recommends vaccination for females aged 13 through 26 years and for males aged 13 through 21 years.…”

Section: Self-protectionmentioning

confidence: 99%

Preventive gynecology: attitude and practice among gynecologists of Central Kerala

Radha

Reena

Jacob

2017

Int J Reprod Contracept Obstet Gynecol

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Background: Carcinoma breast and carcinoma cervix are leading causes for cancer deaths in India. However, they get detected only in late stages of the disease. Preventive measures and early detection of disease will decrease the burden from these cancers. We evaluated the strategies followed by practising gynaecologists of Central Kerala to reduce this burden.Methods: A survey was conducted among 270 practising gynaecologists of Central Kerala, using a questionnaire. This evaluated implementation of screening and preventive measures used by them for self-protection as well as for the women seeking their services. Their attitude regarding HPV vaccine as a preventive measure was also noted.Results: Pap smear was done by only 84(32.8%) out of 256 gynaecologists or their spouses. Routine Pap smear was recommended by 60.5% of private practitioners and 84% of government practitioners. Counselling regarding the HPV vaccine was offered to young women by 37.8% of gynaecologists only. Use of HPV vaccine for their daughters was also quite infrequent (24.1%).Conclusions: The utilization of existing preventive strategies and measures for early detection of premalignant and malignant lesions is far from optimum. There is a need to step up in service training and continuing medical education for health care personnel in this direction.

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Efficacy of Human Papillomavirus 16 and 18 (HPV-16/18) AS04-Adjuvanted Vaccine against Cervical Infection and Precancer in Young Women: Final Event-Driven Analysis of the Randomized, Double-Blind PATRICIA Trial

Cited by 97 publications

References 41 publications

Six‐year multi‐centre, observational, post‐marketing surveillance of the safety of the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 10–25 years in Korea

Six‐year multi‐centre, observational, post‐marketing surveillance of the safety of the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 10–25 years in Korea

Risk of Delayed Human Papillomavirus Vaccination in Inner-City Adolescent Women

Preventive gynecology: attitude and practice among gynecologists of Central Kerala

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