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: 10706959
• 负责人: Erin Kathleen Spiegel
• 金额: $ 10.61万
• 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/10706959
• 关键词: 13 year old; 14 year old; Address; Adherence; Age; Antigens; Area; Awareness; Cancer Etiology; Caregivers; Categories; Cessation of life; Child; Clinical Data; Clinical Trials; Communities; Country; Data; Dermal; Developing Countries; Development; Devices; Dose; Fright; Future; Goals; 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; Program Description; Recommendation; Regimen; Resources; Route; Safety; Savings; Schedule; Surveys; Syringes; System; Target Populations; Technology; Time; Tissues; Vaccinated; Vaccination; Vaccines; Woman; World Health Organization; aged; 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.

项目总结