The Frederick National Laboratory recently announced it is producing an additional round of a Zika virus vaccine for use in ongoing studies to determine the most effective delivery methods and dosages.
According to David Lindsay, director of the laboratory’s Vaccine Clinical Materials Program (VCMP), the vaccine will go to support a National Institute of Allergy and Infectious Diseases (NIAID)-sponsored Phase II trials to prevent Zika infection among those who are naturally exposed to the virus.
NIAID, which developed the vaccine approach called plasmid DNA, sought the lab’s assistance to produce a ready-to-go candidate for use in a Phase I trial. Since 2016, NIAID’s Vaccine Research Center Pilot Plant, which is operated by Frederick’s VCMP, had manufactured a total of 10,000 doses of the vaccine candidate for clinical studies.
“The manufacture by the pilot plant leverages platform fermentation and purification technology developed at the pilot plant going back to facility start-up in 2006,” Lindsay said.
Currently, the Vaccine Research Center will continue its Phase I trial along with planned Phase IIa and IIb trials on Zika prevention. According to Leidos, who operates the Frederick Lab, the vaccine has triggered antibody responses against Zika virus infection.