Study will compare immunogenicity of using PharmaJet Tropis® Intradermal Injection System to traditional Needle and Syringe Intramuscular Administration
GOLDEN, Colo. — November 29, 2022 — PharmaJet®, a company that has developed and commercialized a needle-free platform to more effectively administer drugs and biologics, today announced they received an $800,000+ direct to Phase II grant from the National Institutes of Health (NIH), to evaluate the immunogenicity of intradermal administration of human papillomavirus virus (HPV) vaccine using their Tropis intradermal (ID) Needle-free Injection System (NFIS). The study will compare Tropis intradermal delivery against traditional needle and syringe (N/S) intramuscular administration.
The study, in collaboration with Padjadjaran University (UNPAD) in Indonesia, will begin recruiting approximately 900 girls, aged 9 to 14 years of age in early 2023. This follows PharmaJet’s preliminary studies evaluating intradermal delivery for HPV vaccines.1 Intradermal administration is already widely used for polio vaccine delivery and has been found to be safe, effective, and immunogenic. Intradermal needle-free delivery of polio vaccine using the Tropis NFIS has also been shown to be a preferred approach by healthcare workers and patients.2
Worldwide, cervical cancer is the fourth most frequent cancer in women with an estimated 604,000 new cases in 2020, and a large majority of them (more than 95%) are due to HPV. Of the estimated 342,000 deaths from cervical cancer in 2020, about 90% of these occur in low- and middle-income countries where there is limited access to preventative measures and cervical cancer is often not identified until it has further advanced, and symptoms develop. Additionally, access to treatment of cancerous lesions (for example, cancer surgery, radiotherapy and chemotherapy) may be limited, resulting in a higher rate of death from cervical cancer in these countries.3
“We are pleased to receive this grant from the NIH to evaluate the feasibility of needle-free intradermal vaccine delivery for HPV,” said Erin Spiegel, Vice President of Clinical & Regulatory Affairs for PharmaJet. “Intradermal administration of vaccines can provide benefits for low resource settings including lower costs, increased coverage, and increased acceptability.”
For more information about PharmaJet visit https://pharmajet.com.
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Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Number R44CA261326. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
1 Nelson, E. et al, A pilot randomized study to assess immunogenicity, reactogenicity, safety and tolerability of two human papillomavirus vaccines administered intramuscularly and intradermally to females aged 18-26 years, Vaccine, 25 July 2013, pages 3452-3460.
2 Daly, C. et al, Needle-free injectors for mass administration of fractional dose inactivated poliovirus vaccine in Karachi, Pakistan: A survey of caregiver and vaccinator acceptability, Vaccine, 18 February 2020, pages 1893-1898.
3 Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021:71:209–49. doi:10.3322/caac.21660.
PharmaJet’s mission is to enable greater access to life improving pharmaceuticals. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet Needle-free Systems provide increased vaccine effectiveness, a preferred patient and caregiver experience, and a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® System has CE Mark and WHO PQS certification for intradermal injections. For more information visit https://pharmajet.com. Follow us on LinkedIn.