The needle-free technology company announced that the NIH would be using its device in August of this year. Recently, Ron Lowy, chairman and CEO at PharmaJet provided an update on the trial, commenting that the company is encouraged by the positive results.
“As with many development programs the challenge isn’t that our devices haven’t been proven to work, it is a question as to the effectiveness of the vaccine or therapeutic being studied,” he told us.
Lowy explained the next steps are to complete the Phase I and Phase II steps of the trials with the NIH.
As Outsourcing-Pharma.com previously reported, the device works by delivering medications and vaccines intramuscularly via a narrow, high velocity fluid stream, which Lowy said prevents needle-stick injuries, needle re-use, and cross contamination or spread of diseases.
The device also delivers the vaccine in about 1/10th of a second.
“Our needle-free device is fast, safe, and easy to use, and in some cases has been shown to enhance the effectiveness of certain vaccines,” added Lowy.
The Zika vaccine clinical trial
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), launched the clinical trial earlier this year.
The study is evaluating the experimental vaccine’s safety and ability to generate an immune system response in participants.
At the time of the trial's launch, NIAID Director Anthony S. Fauci, M.D. explained the results in animal testing were encouraging. “We are pleased that we are now able to proceed with this initial study in people,” he said, noting that it will “take some time” before a vaccine is commercially available.
The Phase I clinical trial (VRC 319) is being led by Julie E. Ledgerwood, D.O., chief of the VRC’s clinical trials program.
According to the NIH, if the trial shows favorable safety profile and immune response results, NIAID plans to initiate a Phase II trial in Zika-endemic countries in early 2017.