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Options for design of real-world impact studies of single-dose vaccine schedules.

ABSTRACT: Based on existing evidence for efficacy, savings, and advantages in delivery, some countries may elect to pilot or roll out single-dose human papillomavirus (HPV) vaccination (instead of, or in combination with, two-dose) in advance of a WHO policy decision. Accelerated evidence of population-based effectiveness (hereafter referred to as overall effectiveness, OE) of one-dose vaccine programs could be gained through regular surveys of HPV prevalence in young women before and after vaccination introduction. In order to offer the earliest information on OE, one-dose HPV vaccination should target one or more birth cohorts as close as possible to the age when sexual activity most often starts in a given population. A catch-up one-dose vaccination program of girls up to 18?years of age who would have been too old to profit from the introduction of a routine HPV vaccination program in preadolescents would minimize the interval between vaccination and the possibility to monitor vaccination impact in young women. In addition, catch-up is especially desirable in low- and middle-income countries with little access to screening as "missed" cohorts may face high risk of cervical cancer death. HPV prevalence should be firstly monitored in age groups of women who may already be sexually active but still reluctant to admit it and to accept vaginal examination for the collection of cervical cells. Hence, HPV testing from urine samples, for which good concordance with cervical cells has been proven, offers a feasible approach to assess periodically vaccine OE in representative samples of 17-20?year-old women. This type of observational study would greatly benefit from the presence of a population census and the creation of a vaccination registry. A real-world demonstration of OE of the new schedule would complement the findings of ongoing clinical trials and immunogenicity studies on the efficacy of single-dose HPV vaccination.

SUBMITTER: Franceschi S

PROVIDER: S-EPMC6066174 | biostudies-other | 2018 Aug

REPOSITORIES: biostudies-other

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Options for design of real-world impact studies of single-dose vaccine schedules.

Franceschi Silvia S Clifford Gary M GM Baussano Iacopo I

Vaccine 20180321 32 Pt A

Based on existing evidence for efficacy, savings, and advantages in delivery, some countries may elect to pilot or roll out single-dose human papillomavirus (HPV) vaccination (instead of, or in combination with, two-dose) in advance of a WHO policy decision. Accelerated evidence of population-based effectiveness (hereafter referred to as overall effectiveness, OE) of one-dose vaccine programs could be gained through regular surveys of HPV prevalence in young women before and after vaccination in ...[more]

PMID: 29571973

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Project description:ObjectiveTo investigate the incremental cost effectiveness of two dose human papillomavirus vaccination and of additionally giving a third dose.DesignCost effectiveness study based on a transmission dynamic model of human papillomavirus vaccination. Two dose schedules for bivalent or quadrivalent human papillomavirus vaccines were assumed to provide 10, 20, or 30 years' vaccine type protection and cross protection or lifelong vaccine type protection without cross protection. Three dose schedules were assumed to give lifelong vaccine type and cross protection.SettingUnited Kingdom.PopulationMales and females aged 12-74 years.InterventionsNo, two, or three doses of human papillomavirus vaccine given routinely to 12 year old girls, with an initial catch-up campaign to 18 years.Main outcome measureCosts (from the healthcare provider's perspective), health related utilities, and incremental cost effectiveness ratios.ResultsGiving at least two doses of vaccine seems to be highly cost effective across the entire range of scenarios considered at the quadrivalent vaccine list price of £86.50 (€109.23; $136.00) per dose. If two doses give only 10 years' protection but adding a third dose extends this to lifetime protection, then the third dose also seems to be cost effective at £86.50 per dose (median incremental cost effectiveness ratio £17,000, interquartile range £11,700-£25,800). If two doses protect for more than 20 years, then the third dose will have to be priced substantially lower (median threshold price £31, interquartile range £28-£35) to be cost effective. Results are similar for a bivalent vaccine priced at £80.50 per dose and when the same scenarios are explored by parameterising a Canadian model (HPV-ADVISE) with economic data from the United Kingdom.ConclusionsTwo dose human papillomavirus vaccine schedules are likely to be the most cost effective option provided protection lasts for at least 20 years. As the precise duration of two dose schedules may not be known for decades, cohorts given two doses should be closely monitored.

Project description:BackgroundThere are currently no standard therapy regimens for the third-line treatment of metastatic pancreatic cancer (mPC) patients. The aim of the present study was to compare the efficacy and safety of different third-line therapy regimens for mPC in the real-world.MethodsThis study retrospectively analyzed mPC patients admitted to Zhejiang Provincial People's Hospital between June 2013 and January 2023. All patients' diagnoses were pathologically confirmed and their treatment was continued after the second-line therapy failed. The primary study endpoints included median overall survival (mOS), median progression-free survival (mPFS), and disease control rate (DCR).ResultsA total of 72 patients were enrolled in the study. Of these, 36 patients received chemotherapy alone, 16 received chemotherapy combined with targeted therapy or immunotherapy, 14 received chemotherapy-free antitumor therapy, and six received palliative care. The mPFS value for these groups was 4.40 months, 5.20 months, 2.33 months, and 0.80 months, respectively. The mOS value was 6.90 months, 5.90 months, 3.33 months, and 0.80 months, respectively. The DCR was 33.4%, 31.3%, 21.4%, and 0.0%, respectively. Overall, there were significant differences in prognosis between the palliative care group and the other treatment groups (mOS, P < 0.001; mPFS P < 0.001; DCR, P < 0.001). The differences among the mPFS, mOS, and DCR for different antitumor therapy regimens were not statistically significant. Compared to the chemotherapy alone group, the chemotherapy combined with targeted therapy or immunotherapy group experienced more adverse events (100% vs. 75.0%; P = 0.002). Chemotherapy combined with targeted therapy or immunotherapy was associated with a higher risk of grade 3/4 hyperaminotransferemia compared to chemotherapy alone (31.3% vs. 0.0%; P = 0.020) and chemotherapy-free antitumor therapy (31.3% vs. 0.0%; P = 0.020).ConclusionsThird-line antitumor therapy can prolong the survival time of patients with mPC. Targeted therapy or immunotherapy failed to further improve survival benefits based on chemotherapy results. Patients who underwent the third-line treatment with good physical status and family history of cancer were independent prognostic factors for longer mOS. The sequencing of fluorouracil and gemcitabine in the front-line therapy did not affect third-line mOS.

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Options for design of real-world impact studies of single-dose vaccine schedules.

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Options for design of real-world impact studies of single-dose vaccine schedules.

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