Pennsylvania's Inovio Pharmaceuticals ($INO) continues to forge ahead with its Zika work, announcing Monday that its second vaccine trial in humans is underway in Puerto Rico. As of mid-August, the U.S. territory and Caribbean island had recorded 10,690 Zika cases, leading HHS officials to declare a public health emergency there.
For Inovio’s newest study, 80 participants will receive the company’s DNA vaccine GLS-5700, while 80 participants will receive placebo. All told, the researchers will be examining the vaccine’s safety, tolerability and immunogenicity as well as an exploratory endpoint comparing Zika infection rates for the vaccine and control groups.
“If the results are promising, we plan to meet with regulators in 2017 to map out the most efficient path forward to develop our Zika vaccine and help mitigate this widespread Zika outbreak that has expanded into the continental United States,” Inovio CEO J. Joseph Kim said in a statement.
To administer the vaccine for Inovio’s newest trial, researchers will use the the company’s Cellectra device, which “has been shown to maximize antigen expression and immune responses in multiple human studies,” according to a release.
It’s Inovio’s second Zika vaccine trial underway after it in June became the first to reach the clinic, testing its candidate in 40 healthy subjects. Inovio expects to report results for that trial this year, it reiterated on Monday.
National Institutes of Health became the second to reach the clinic in August, entering Phase I with a DNA vaccine for a study at three sites in the U.S. The group said it'll employ a similar method to the one used in developing a West Nile virus vaccine, which was found to be safe in early tests.
Other government teams have attracted big-name partners in Sanofi ($SNY) and GlaxoSmithKline ($GSK) to test different approaches. Early in July, GSK said it’d pair with the NIH on a project using technology called self-amplifying mRNA, or SAM, just one day after Sanofi signed on with the Walter Reed Army Institute of Research to work with a Zika purified inactivated virus (ZPIV) vaccine.
But Congressional inaction could impact some of the work out of the NIH. Following Congress’ inability to reach an agreement on Zika funding before breaking for vacation, officials have said research funds could run out. HHS transferred $81 million to two teams in response.
- here's the release
Inovio set for first Zika vaccine human trial
GSK jumps into Zika vax hunt on heels of Sanofi's deal
NIH kicks off PhI trial for Zika vax as caseload rises in U.S.
Sanofi enlists for top Army hospital’s fight against Zika virus