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The eight-year long-term follow-up on the effectiveness of the quadrivalent human papillomavirus vaccine in Chinese women 20-45 years of age.

ABSTRACT: The quadrivalent human papillomavirus (4vHPV) vaccine has shown confirmative effectiveness in preventing HPV-related diseases among women and men around the globe. The phase III, randomized, double-blind efficacy study (Base study, NCT00834106) conducted in China showed 100% efficacy against HPV 16/18-related cervical intraepithelial neoplasia and efficacy against HPV persistent infection for 78 months. Participants aged 20-45 years who received three doses of 4vHPV vaccine or placebo during the base study were selected and invited for this long-term follow-up (LTFU) study to assess the long-term effectiveness of the 4vHPV vaccine in preventing HPV-related diseases. A total of 368 participants were included in this LTFU study with a median follow-up of 94 months. Among 27 participants (Vaccine vs. Placebo: 8 vs. 19) who underwent colposcopy and biopsy due to cervical cytological abnormalities or HPV infection, no HPV-16/18-related cases of cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN) was observed in the vaccine group while two HPV-16-related cases (CIN1/VaIN) were observed in the placebo group. There were another two HPV-related cases (non-vaccine HPV types) found in the placebo group. Consistent with the findings from global studies that suggested long-term efficacy of 4vHPV vaccine, our study showed continued protective effect of 4vHPV vaccine against HPV-related precancerous diseases through a median follow-up time of 94 months with the longest follow-up time of 125 months after completing three doses of vaccination among Chinese women 20-45 years of age.

SUBMITTER: Zhao C

PROVIDER: S-EPMC9225595 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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The eight-year long-term follow-up on the effectiveness of the quadrivalent human papillomavirus vaccine in Chinese women 20-45 years of age.

Zhao Chao C Zhao Yun Y Li Jingran J Li Mingzhu M Su Yanyan Y Mi Xin X La Tu Su Yi SY Shen Danhua D Ren Lihua L Li Yanyan Y Wang Linhong L Wei Lihui L

Human vaccines & immunotherapeutics 20220331 5

The quadrivalent human papillomavirus (4vHPV) vaccine has shown confirmative effectiveness in preventing HPV-related diseases among women and men around the globe. The phase III, randomized, double-blind efficacy study (Base study, NCT00834106) conducted in China showed 100% efficacy against HPV 16/18-related cervical intraepithelial neoplasia and efficacy against HPV persistent infection for 78 months. Participants aged 20-45 years who received three doses of 4vHPV vaccine or placebo during the ...[more]

PMID: 35358015

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Project description:BackgroundThe quadrivalent human papillomavirus (qHPV) vaccine prevented vaccine HPV type-related infection and disease in young women in the 4-year FUTURE II efficacy study (NCT00092534). We report long-term effectiveness and immunogenicity at the end of 14 years of follow-up after enrollment in FUTURE II.MethodsYoung women (16-23 years of age) from Denmark, Iceland, Norway, and Sweden who received three qHPV vaccine doses during the randomized, double-blind, placebo-controlled FUTURE II base study were followed for effectiveness for an additional ≥10 years through national registries. Tissue samples including but not limited to those collected during organized cervical cancer screening programs were obtained from regional biobanks to be adjudicated for histopathology diagnosis and tested for HPV DNA. The observed incidence of HPV16/18-related high-grade cervical dysplasia (primary outcome) was compared with recent historical background incidence rates in an unvaccinated population. Serum was collected at years 9 and 14 to assess antibody responses.FindingsNo cases of HPV16/18-related high-grade cervical dysplasia were observed in the per-protocol effectiveness population (N = 2121; 24,099·0 person-years of follow-up) during the entire study. Vaccine effectiveness of 100% (95% CI 94·7-100) was demonstrated for ≥12 years, with a trend toward continued protection through 14 years post-vaccination. Seropositivity rates at study conclusion were >90% (HPV6/11/16) and 52% (HPV18) using competitive Luminex immunoassay, and >90% (all four HPV types) using the more sensitive IgG Luminex immunoassay.InterpretationVaccination of young women with qHPV vaccine offers durable protection against HPV16/18-related high-grade cervical dysplasia for ≥12 years, with a trend toward continued protection through 14 years post-vaccination, and induces sustained HPV6/11/16/18 antibody responses for up to 14 years post-vaccination. There was no evidence of waning immunity, suggesting no need for a booster dose during that period.FundingMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Project description:BackgroundIn the United States, the routine age for human papillomavirus (HPV) vaccination is 11 to 12 years, with catch-up vaccination through age 26 years for women and 21 years for men. U.S. vaccination policy on use of the 9-valent HPV vaccine in adult women and men is being reviewed.ObjectiveTo evaluate the added population-level effectiveness and cost-effectiveness of extending the current U.S. HPV vaccination program to women aged 27 to 45 years and men aged 22 to 45 years.DesignThe analysis used HPV-ADVISE (Agent-based Dynamic model for VaccInation and Screening Evaluation), an individual-based transmission dynamic model of HPV infection and associated diseases, calibrated to age-specific U.S. data.Data sourcesPublished data.Target populationWomen aged 27 to 45 years and men aged 22 to 45 years in the United States.Time horizon100 years.PerspectiveHealth care sector.Intervention9-valent HPV vaccination.Outcome measuresHPV-associated outcomes prevented and cost-effectiveness ratios.Results of base-case analysisThe model predicts that the current U.S. HPV vaccination program will reduce the number of diagnoses of anogenital warts and cervical intraepithelial neoplasia of grade 2 or 3 and cases of cervical cancer and noncervical HPV-associated cancer by 82%, 80%, 59%, and 39%, respectively, over 100 years and is cost saving (vs. no vaccination). In contrast, extending vaccination to women and men aged 45 years is predicted to reduce these outcomes by an additional 0.4, 0.4, 0.2, and 0.2 percentage points, respectively. Vaccinating women and men up to age 30, 40, and 45 years is predicted to cost $830 000, $1 843 000, and $1 471 000, respectively, per quality-adjusted life-year gained (vs. current vaccination).Results of sensitivity analysisResults were most sensitive to assumptions about natural immunity and progression rates after infection, historical vaccination coverage, and vaccine efficacy.LimitationUncertainty about the proportion of HPV-associated disease due to infections after age 26 years and about the level of herd effects from the current HPV vaccination program.ConclusionThe current HPV vaccination program is predicted to be cost saving. Extending vaccination to older ages is predicted to produce small additional health benefits and result in substantially higher incremental cost-effectiveness ratios than the current recommendation.Primary funding sourceCenters for Disease Control and Prevention.

Project description:BackgroundTo report clinical and activity-specific outcomes after arthroscopic rotator cuff repair (ARCR) for full-thickness supraspinatus tears in active individuals aged less than or equal to 45 years. The pre hoc hypothesis was that patients in this age group would demonstrate significant improvements in clinical outcomes following ARCR along with a significant improvement of athletic abilities.MethodsPatients were included in this study if they were (1) active individuals aged between 18 and 45 years at the time of surgery, (2) had a full-thickness rotator cuff tear of the supraspinatus tendon with or without anterior or posterior extension, and (3) underwent ARCR. Preoperative and postoperative patient-reported outcomes scores including the American Shoulder and Elbow Surgeons (ASES) score; Disabilities of Arm, Shoulder and Hand; Single Assessment Numeric Evaluation; and Short Form-12 Physical Component Summary were prospectively collected and postoperative patient satisfaction (scale of 1-10) was recorded at a minimum of 2 years postoperatively. Attainment of the minimal clinically important difference and patient acceptable symptom state for the ASES was calculated. Athletic activity-specific outcomes and return to activity were investigated prospectively via a custom-made comprehensive questionnaire.ResultsBetween November 2005 and June 2020, of 1149 RCRs performed by the senior author, 54 patients (mean age 40.9 years, 13 female; follow-up 69.7 ± 35.2 months in a range of 24.6-179.6 months) were included into the outcomes analysis. Of those, 4 patients (7.4%) had progressed to revision RCR. At a follow-up of 5.8 years, outcome scores had significantly improved compared to preoperative baselines (ASES 55.6 ± 13.8 to 90.1 + 15.8; P < .001; Disabilities of Arm, Shoulder and Hand 38.9 ± 18.4 to 11.9 ± 17.1; P < .001, Single Assessment Numeric Evaluation 60.7 ± 22.7 to 79.3 ± 27.6; P = .001, Short Form-12 Physical Component Summary 41.6 ± 8.3 to 51.9 ± 9.0; P ≤ .001). Ninety three point six percent of the patients reached the minimal clinically important difference and 72.6% reached the patient acceptable symptom state. Median satisfaction was 9.5/10. Eighty six percent of the patients returned to sports, while 67% of the patients returned to a similar level compared to preoperatively. All sport-specific metrics such as shoulder strength and endurance (P < .001), intensity (P < .001), and impairments from pain affecting speed (P = .002), endurance (P = .002), and competition (P < .001) significantly improved postoperatively.ConclusionARCR of full-thickness rotator cuff tear in active individuals aged 45 years or less results in a clinically relevant improvement of outcomes, function, and quality of life at a minimum of 2 years and mean 5.8-year follow-up with a low rate of revision. While 86% of patients were able to return to activity and sport-specific outcome metrics significantly and substantially improved compared to preoperatively, a return to preinjury levels was not reliably achieved in all patients, with particular limitations observed in overhead active individuals. The data support the hypothesis that patients in this age group demonstrate significant improvements in clinical outcomes following ARCR along with significant improvements in athletic abilities.

Dataset Information

The eight-year long-term follow-up on the effectiveness of the quadrivalent human papillomavirus vaccine in Chinese women 20-45 years of age.

Publications

The eight-year long-term follow-up on the effectiveness of the quadrivalent human papillomavirus vaccine in Chinese women 20-45 years of age.

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