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

> **NIH NIH R44** · PHARMAJET, INC. · 2022 · $737,511

## Abstract

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.

## Key facts

- **NIH application ID:** 10322899
- **Project number:** 1R44CA261326-01A1
- **Recipient organization:** PHARMAJET, INC.
- **Principal Investigator:** Erin Kathleen Spiegel
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $737,511
- **Award type:** 1
- **Project period:** 2022-09-20 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10322899

## Citation

> US National Institutes of Health, RePORTER application 10322899, Translational Use of Intradermal Needle-free Injector to facilitate and optimize global fractional dose HPV vaccine administration (1R44CA261326-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10322899. Licensed CC0.

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