First Human Study Assess U.S. DoD DNA Vaccine Candidate Against Venezuelan Equine Encephalitis
PharmaJet® 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.
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 infection and is listed as a potential biothreat agent with no approved human vaccine or therapeutic.
Disease outbreaks frequently involve equines– horses, donkeys, mules, zebras – and humans.
DNA vaccination has proven particularly effective at eliciting protective immune responses against the alphavirus challenge.
As previously reported, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and PharmaJet found, in a non-human primate 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.
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.
President and CEO of PharmaJet, Chris Cappello, said in a press release, "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."
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.
The study, in collaboration with USAMRIID, aims to advance further the clinical assessment of the vaccine with the PharmaJet Precision Delivery Systems: Tropis Intradermal and Stratis Intramuscular.
PharmaJet Systems effectively delivers nucleic acid-based vaccines compatible with military operations and the warfighter environment, in addition to being preferred by end-users compared to other delivery technologies.