Translational Use of Intradermal Needle-free Injector to facilitate and optimize global fractional dose HPV vaccine administration

皮内无针注射器的转化使用促进和优化整体分剂量 HPV 疫苗接种

• 批准号: 10322899
• 负责人: Erin Kathleen Spiegel
• 金额: $ 73.75万
• 依托单位: PHARMAJET, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10322899
• 关键词: 13 year old; 14 year old; Address; Adherence; Age; Antigens; Area; Awareness; Cancer Etiology; Caregivers; Cessation of life; Child; Clinical Data; Clinical Trials; Communities; Country; Data; Dermal; Developing Countries; Development; Devices; Dose; Fright; Future; Goals; Hand; Health; Human Papilloma Virus Vaccination; Human Papilloma Virus Vaccine; Human Papillomavirus; Human papilloma virus infection; Immune response; Immunity; Immunization; Immunization Programs; Immunization Schedule; Income; Indonesia; Injections; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Methods; Modeling; Needles; Needlestick Injuries; Pain; Pakistan; Paper; Parents; Patients; Phase; Phobias; Policies; Poliovirus Vaccines; Positioning Attribute; Prevention; Procedures; Regimen; Resources; Route; Safety; Savings; Schedule; Surveys; Syringes; System; Target Populations; Technology; Time; Tissues; Vaccinated; Vaccination; Vaccines; Woman; World Health Organization; aged; base; cancer type; cervical cancer prevention; cost; cost effective; disease transmission; experience; girls; global health; health organization; high risk; immunogenicity; improved; intradermal injection; low and middle-income countries; low income country; non-compliance; portability; prevent; programs; response; seroconversion; sexually active; tool; vaccination strategy; vaccine access; vaccine delivery; vaccine immunogenicity

PROJECT SUMMARY Cervical cancer is the fourth most common cancer in women, contributing to about 570,000 new cases and more than 300,000 deaths in 2018, most of it occurs in the low- and middle-income countries (Bray, 2018). In Indonesia, cervical cancer is the second most prevalent type of cancer among women, with 32,000 new cases and 18,000 deaths (Global Cancer Observatory, 2019). It has been shown that human papillomavirus (HPV) infection is the major causative agent of cervical cancer (Bosch, 2002). In 2017, WHO released an HPV vaccine position paper that stated HPV vaccines should be included in national immunization programs with its primary target population is 9-14 year old girls, prior to becoming sexually active (World Health Organization, 2017). Vaccination represents the most cost-effective and efficient way for the prevention of cervical cancer caused by human papillomavirus. Currently, HPV vaccine has been introduced in nearly 100 countries globally (52%), mainly in the upper-middle- and high-income countries. However, its access in the highest burden countries (low and middle income) remains lagging. Furthermore, previous data collected by global health organizations have shown continued low compliance rates for HPV vaccines, partly attributable to needle-phobia. It is predicted that this issue will persist unless a new strategy for vaccination is introduced. In this direct to Phase II proposal, we will explore the feasibility and potential benefits of a reduced dose intradermal strategy for HPV vaccines. In this larger study, we will evaluate doses and routes of administration to determine the immunogenicity, reactogenicity, and levels of patient and caregiver acceptance for each. In settings with minimal resources, the benefits of delivery with needle-free injection are predicted to include dose savings, increased compliance, and the prevention of needle-stick injuries and disease transmission. The results from these studies will provide clinical data to answer the main problems with the current HPV vaccine schedule: 1) availability of vaccine doses; 2) cost; and 3) acceptability & compliance. This data will be a first step to facilitate future policy discussions and global health strategies regarding administration of fiHPV vaccines across Indonesia and other developing countries. The immediate next steps will include planning a larger roll-out campaign across multiple areas of Indonesia, notably in further remote areas where vaccination compliance has been historically low. Ultimately, these studies will be used as a tool to increase awareness of the PharmaJet Tropis Needle- free injection system as a method for fiHPV administration that may aid in country-wide and worldwide vaccine compliance and acceptability to schedules as recommended by the WHO and Ministries of Health.

项目概要 宫颈癌是女性第四大常见癌症，新增病例约 570,000 例 2018 年死亡人数超过 30 万人，其中大部分发生在低收入和中等收入国家（Bray， 2018）。在印度尼西亚，宫颈癌是女性中第二常见的癌症类型， 新增病例 32,000 例，死亡 18,000 例（全球癌症观察站，2019 年）。研究表明，人类 乳头瘤病毒（HPV）感染是宫颈癌的主要病原体（Bosch，2002）。 2017年， 世界卫生组织发布HPV疫苗立场文件，指出HPV疫苗应纳入国家疫苗接种计划 免疫规划的主要目标人群是9-14岁尚未发生性行为的女孩 积极（世界卫生组织，2017）。疫苗接种是最具成本效益和效率的 预防人乳头瘤病毒引起的宫颈癌的方法。目前，HPV疫苗已 全球近 100 个国家（52%）已推出，主要集中在中高收入和高收入国家 国家。然而，在负担最高的国家（低收入和中等收入），其获取仍然滞后。 此外，全球卫生组织之前收集的数据显示，持续的低水平 HPV 疫苗的依从率，部分归因于针头恐惧症。预计这个问题将 除非引入新的疫苗接种策略，否则这种情况将会持续下去。 在这个直接进入第二阶段的提案中，我们将探讨减少剂量的可行性和潜在好处 HPV 疫苗的皮内注射策略。在这项更大规模的研究中，我们将评估剂量和途径 给药以确定患者和护理人员的免疫原性、反应原性和水平 每一个的接受。在资源最少的环境中，无针注射分娩的好处 预计将包括节省剂量、提高依从性以及预防针刺伤 和疾病传播。这些研究的结果将提供临床数据来回答主要问题 当前HPV疫苗接种计划存在的问题：1）疫苗剂量的可用性； 2）成本；和 3) 可接受性和合规性。这些数据将是促进未来政策讨论和全球 印度尼西亚和其他发展中国家关于注射 fiHPV 疫苗的健康战略 国家。接下来的步骤将包括计划在多个领域开展更大规模的推广活动 印度尼西亚，特别是在疫苗接种遵守率历来较低的偏远地区。 最终，这些研究将被用作提高 PharmaJet Tropis 针的认识的工具 免费注射系统作为 fiHPV 管理的一种方法，可能会在全国和全球范围内提供帮助 疫苗合规性和对世界卫生组织和各部委建议的时间表的可接受性 健康。