Understanding the public health value and defining preferred product characteristics for therapeutic human papillomavirus (HPV) vaccines: World Health Organization consultations, October 2021—March 2022

Prudden, H; Achilles, Sharon L.; Schocken, Celina; Broutet, Nathalie; Canfell, Karen; Akaba, Hiroki; Basu, Partha; Bhatla, Neerja; Chirenje, Zvavahera M.; Delany‐Moretlwe, Sinead; Denny, Lynette; Gamage, Deepa G.; Herrero, Rolando; Hutubessy, Raymond; Villa, Luísa Lina; Murillo, Raúl; Schiller, John T.; Stanley, Margaret; Temmerman, Marleen; Zhao, Fen; Kaslow, David C.; Dull, Peter; Gottlieb, Sami L.

doi:10.1016/j.vaccine.2022.08.020

Cited by 20 publications

(8 citation statements)

References 39 publications

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“…There are currently no therapeutic vaccine products on the market, but this is an active and potentially highly influential area of research, with at least one clinical trial underway (59,60). We therefore included a basic infrastructure for modeling therapeutic vaccination in the model.…”

Section: Design and Implementationmentioning

confidence: 99%

“…Ongoing World Health Organization consultations have already identified at least two high-level use cases for a therapeutic vaccine candidate: (1) a mass-vaccination approach in which the therapeutic vaccine would be delivered broadly to an entire population without requiring a positive test result; (2) a screen-and-vaccinate approach, where the therapeutic vaccine would be integrated within existing or new screening programs, e.g. offered to all women who screened positive for HPV (60). HPVsim provides default vaccine delivery interventions to cater to both of these scenarios.…”

Section: Design and Implementationmentioning

confidence: 99%

“…Therapeutic vaccine products: There are currently no therapeutic vaccine products on the market, although at least one clinical trial is underway (45,46). HPVsim includes basic infrastructure for modeling therapeutic vaccination.…”

Section: Therapeutic Vaccinationmentioning

confidence: 99%

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HPVsim: An agent-based model of HPV transmission and cervical disease

Stuart

Cohen

Kerr

et al. 2023

Preprint

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In 2020, the WHO launched its first Global Strategy to Accelerate the Elimination of Cervical Cancer, outlining an ambitious set of targets for countries to achieve over the next decade. At the same time, new tools, technologies, and strategies are in the pipeline that may improve screening performance, expand the reach of prophylactic vaccines, and prevent the acquisition, persistence and progression of oncogenic HPV. Detailed mechanistic modeling can help identify the combinations of current and future strategies to combat cervical cancer. Open-source modeling tools are needed to shift the capacity for such evaluations in-country. Here, we introduce the Human papillomavirus simulator (HPVsim), a new, flexible agent-based model that can be parameterized with country-specific vital dynamics, structured sexual networks, co-transmitting HPV genotypes, B- and T-cell mediated immunity, and high-resolution disease natural history. HPVsim is designed with a user-first lens: it is implemented in Python, has built-in tools for simulating commonly-used interventions, includes a comprehensive set of tests and documentation, and runs quickly (seconds to minutes) on a laptop. Useful complexity was not sacrificed: the platform is flexible, allowing bespoke scenario modeling.

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Section: Design and Implementationmentioning

confidence: 99%

Section: Design and Implementationmentioning

confidence: 99%

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HPVsim: An agent-based model of HPV transmission and cervical disease

Stuart

Cohen

Kerr

et al. 2023

Preprint

View full text Add to dashboard Cite

show abstract

“…While several therapeutic vaccines that target early stage invasive cervical cancers and high-grade lesions have been tested in clinical trials and one vaccine targeting clearance of infection reached phase 1/2a trials before dissolving, an HPV therapeutic vaccine that targets productive infection is still in the early stages of discovery and identification of preferred product characteristics (19)(20)(21). Such a vaccine has the potential to meet the needs of women who have been missed by prophylactic vaccination and may circumvent some of the scalability and infrastructure challenges of traditional screening and treatment programs.…”

Section: Introductionmentioning

confidence: 99%

Understanding the key determinants of an HPV therapeutic vaccine: a modeling analysis

Stuart

Klein

Kerr

et al. 2023

Preprint

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Despite incredibly effective tools to prevent HPV infection and treat precancerous lesions, the scale-up of existing interventions in most low and middle-income countries has been slow, leaving a residual burden of invasive cervical cancer that will persist for decades. An HPV therapeutic vaccine may overcome some of the scalability and infrastructure challenges of traditional screening and treatment programs, though its potential public health value depends upon its characteristics, delivery strategy, and the underlying natural history on which it would act. This analysis uses HPVsim, an open-access agent-based simulation framework, to evaluate the impact of a potential HPV therapeutic vaccine with varying scale-up of existing preventive interventions. To illustrate the sensitivity of results to natural history assumptions, we calibrate two models reflecting uncertainty in the natural history of HPV infection and cervical disease. We find that an HPV therapeutic vaccine may avert 7% to 30% of cervical cancers over 30 years and 25% to 60% of cervical cancers over 70 years. The size of the impact is sensitive to rates of background intervention scale-up, the characteristics of the vaccine, including ability to establish long-lasting immune memory, and the underlying natural history assumptions. Even with background intervention scale-up reaching WHO cervical cancer elimination target levels, an HPV therapeutic vaccine might have efficiency comparable to many other widely administered vaccines such as against MenA, rotavirus, and PCV. This work highlights the importance of the underlying natural history assumptions in mathematical models and the need to explicitly account for parametric uncertainty.

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“…Several therapeutic vaccines have been tested, with varying success. Vaccines targeting early stage invasive cervical cancer and high-grade lesions have been tested in clinical trials, several products that work to clear infection have reached phase 1/2a trials, and one candidate targeting productive infection is in early stages of discovery (19)(20)(21). These HPV therapeutic vaccines have the potential to meet the needs of women who have been missed by prophylactic vaccination and may circumvent some of the scalability and infrastructure challenges of traditional screening and treatment programs.…”

Section: Introductionmentioning

confidence: 99%

Understanding the key determinants of an HPV therapeutic vaccine: a modeling analysis

Cohen,

Stuart,

Lee

et al. 2023

Preprint

Self Cite

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Despite incredibly effective tools to prevent HPV infection and treat precancerous lesions, the scale-up of existing interventions in most low and middle-income countries has been slow, leaving a residual burden of invasive cervical cancer that will persist for decades. An HPV therapeutic vaccine may overcome some of the scalability and infrastructure challenges of traditional screening and treatment programs, though its potential public health value depends upon its characteristics, delivery strategy, and the underlying immunity of the population on which it would act. This analysis uses HPVsim, an open-access agent-based simulation framework, to evaluate the impact of a range of potential HPV therapeutic vaccines with varying scale-up of existing preventive interventions in nine high-burden low- and middle-income countries (LMICs). For each setting, the model is populated with context-specific demographic and behavioral data, and calibrated to fit estimates of HPV and cervical disease by age. We find that an HPV therapeutic vaccine that clears 90% of virus and regresses 50% of high-grade lesions, reaching 70 percent of 35-45 year old women starting in 2030, could avert 1.2-2.2 million incident cases of cervical cancer, 500,000-1.2 million cervical cancer deaths and 20-40 million disability adjusted life years (DALYs) in the modeled high-burden LMICs over 30 years. The size of the impact is sensitive to rates of background intervention scale-up and the characteristics of the vaccine, including ability to establish long-lasting immune memory.

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Understanding the public health value and defining preferred product characteristics for therapeutic human papillomavirus (HPV) vaccines: World Health Organization consultations, October 2021—March 2022

Cited by 20 publications

References 39 publications

HPVsim: An agent-based model of HPV transmission and cervical disease

HPVsim: An agent-based model of HPV transmission and cervical disease

Understanding the key determinants of an HPV therapeutic vaccine: a modeling analysis

Understanding the key determinants of an HPV therapeutic vaccine: a modeling analysis

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