First Human Clinical Study to Assess U.S. Department of Defense DNA Vaccine Candidate against Venezuelan Equine Encephalitis Delivered with PharmaJet Precision Delivery Systems.

  • Phase 1 human clinical study will evaluate safety and immunogenicity of a Venezuelan Equine Encephalitis (VEE) DNA vaccine.
  • The study includes PharmaJet’s Precision Delivery Systems and is supported by the U.S. Department of Defense (DoD).
  • As a CDC category B biothreat, alphaviruses (such as VEE virus) are one of many DoD DNA vaccines under evaluation for active immunization with PharmaJet Systems.

GOLDEN, Colo. — November 16, 2023 — PharmaJet®, a company that has developed and commercialized a needle-free platform to more effectively administer drugs and biologics, today announced the start of the first human clinical trial for a Venezuelan Equine Encephalitis (VEE) vaccine delivered with PharmaJet Precision Delivery Systems. The Phase 1 study, sponsored by PharmaJet, aims to identify the optimal dose, vaccination schedule and delivery system most suitable for use in subsequent broader clinical evaluations of the VEE DNA vaccine candidate.

The VEE DNA vaccine candidate is being evaluated as part of a multi-year agreement between PharmaJet and the Joint Science and Technology Office of the U.S. Defense Threat Reduction Agency (DTRA). The study, in collaboration with USAMRIID, aims to further advance the clinical assessment of the vaccine with the PharmaJet Precision Delivery Systems: Tropis Intradermal (ID) and Stratis Intramuscular (IM). The PharmaJet Systems effectively deliver nucleic acid-based vaccines and are compatible with military operations and the warfighter environment, in addition to being preferred by end-users compared to other delivery technologies.

Venezuelan Equine Encephalitis Virus (VEEV) is a mosquito-borne alphavirus that has caused sporadic outbreaks and epidemics in North Central and South America. Aerosolized VEEV is highly infectious with greater mortality rates than natural infection1 and is listed as a potential biothreat agent with no approved human vaccine or therapeutic. DNA vaccination has proven particularly effective at eliciting protective immune responses against the alphavirus challenge.2

As previously reported, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and PharmaJet found, in a non-human primate (NHP) challenge study, that a prime and single boost by either the intramuscular (Stratis) or intradermal route (Tropis) resulted in humoral and cellular immune responses that provided significant protection against VEEV disease and viremia.3 These results paved the way for advancing the candidate vaccine into human trials and approval to proceed was recently granted by the Institutional Review Board (IRB), the Army’s Office of Human Research Oversight, and the FDA.

Chris Cappello, President and CEO, PharmaJet said, “We are pleased to be collaborating with the U.S. Government to continue to progress their VEE DNA vaccine development. The PharmaJet Precision Delivery Systems are optimized for field use and have also shown immunogenicity levels higher than with needle-syringe. We look forward to the clinical results from the human trial of this promising DNA vaccine candidate with our commercially available needle-free precision delivery systems.”

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Effort sponsored by the U.S. Government under Other Transaction number W15QKN-16-9-1002 between the MCDC, and the Government. The US Government is authorized to reproduce and distribute reprints for Governmental purposes notwithstanding any copyright notation thereon. The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government.

1 Franz, D. R. et al. Clinical recognition and management of patients exposed to biological warfare agents. Clin. Lab. Med. 21, 435–473 (2001)
2 Lundstrum, K, Plasmid DNA-Based Alphavirus Vaccines, Vaccines (Basel), 2019 March; 7(1):29
3 Suschak, J. et al, A DNA vaccine targeting VEE virus delivered by needle-free jet injection protects macaques against aerosol challenge, npj Vaccines 7, 46 (2022)

About PharmaJet
The PharmaJet vision is to enable greater access to life-saving vaccines and pharmaceuticals globally. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet Precision Delivery 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. They are both commercially available for global immunization programs. For more information visit Follow us on LinkedIn.