- PharmaJet needle-free delivery enhances immune response and provides safety, efficacy, efficiency, and patient comfort for intradermal and intramuscular applications, outperforming traditional needle and syringe methods.
- Partners’ data continues to support PharmaJet’s Tropis® and Stratis® Needle-free Delivery Systems as optimal methods for delivering nucleic acid vaccines.
- Self-amplifying mRNA (samRNA) lipid nano-emulsion (LNE): The safety profile of GEMCOVAC®-OM COVID-19 vaccine administered intradermally with Tropis was assessed in Phase 2 and 3 studies in comparison to a ChADOx1 nCoV-19 adenoviral vector vaccine administered with N/S (IM). Immunogenicity data supported a favorable safety profile, leading to the Emergency Use Authorization (EUA) GEMCOVAC-OM in India, the world’s first samRNA-LNE vaccine to be approved for use in humans, delivered exclusively with Tropis.1
- mRNA-protamine: A first in-human Phase 1 trial compared multiple methods of delivery for a prophylactic mRNA rabies vaccine candidate, including Tropis ID, Stratis IM, and N/S (ID/IM). Participants vaccinated with the Tropis and Stratis Needle-free Injection Systems showed strong immune responses, developing virus-neutralizing antibodies, while N/S failed to induce a detectable antibody response in nearly all participants across several dose and route groups.2
- mRNA-LNP: Tropis was used to administer luciferase mRNA-LNP to study the effect that jet injection would have on mRNA-LNP compared to N/S, via bench and in vivo expression assays. While other characterization parameters remained largely similar, Tropis injection shifted the particle size distribution toward a larger size compared to N/S. However, in vivo expression with Tropis delivery trended higher than N/S. This showed that, despite some biophysical differences after injection, Tropis delivery did not affect in vivo expression of mRNA-LNP.3
Refer to Instructions for Use to ensure safe injections and to review risks.
1 Saraf, et al (2024). An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial. Nat Med, 30(5), 1363-1372. 2Alberer, et al (2017). Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: An open-label, non-randomised prospective, first-in-human phase 1 clinical trial. The Lancet, 390(10101) 1511-1520. 3 Meyer, et al (2024). Evaluation of luciferase and prefusion-stability F protein from respiratory syncytial virus mRNA/LNPs in pre-clinical models using jet delivery compared to needle and syringe. Vaccine X, 16, 100420. About PharmaJet The PharmaJet mission is to improve the performance and outcomes of injectables with our enabling technology that better activates the immune system. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet Precision Delivery Systems™ can improve vaccine effectiveness and promote a preferred patient and caregiver experience while being 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. They are both commercially available for global immunization programs. For more information or if you are interested in partnering with PharmaJet to improve the impact of your novel development program, visit https://pharmajet.com or contact PharmaJet here. Follow us on LinkedIn. ABOUT International mRNA Health Conference The International mRNA Health Conference (Conference Days, 12-14 November 2024) is the premier meeting destination for industry and academic professionals to explore the rapidly advancing science and business of mRNA medicines. The mRNA Health Conference provides participants an opportunity to learn more about developments in mRNA technologies through scientific presentations by some of the most esteemed experts in the field and extensive networking opportunities. The event brings together over 900 attendees from both academic institutions and leading pharma and biotech companies. The 2024 conference will be available virtual and on-site in Boston at the Hilton Boston Park Plaza Hotel.