Woodlands firm key in making Zika vaccine

Local laboratory is now producing doses for first phase of clinical trial

As worry over the spread of the incurable Zika virus persists, scientists in The Woodlands have been at work manufacturing a vaccine that is now being tested on humans.

VGXI Inc., a contract manufacturer of DNA plasmids used in trials for vaccines and gene therapies, produced the vaccine at its facilities on Research Forest Drive. VGXI’s parent company, GeneOne Life Science, which is sponsoring the clinical trial, received quick approval from the U.S. Food and Drug Administration and Health Canada’s Health Products and Food Branch to conduct the first phase of the trial at three sites: Miami, the University of Pennsylvania Hospital and Quebec City, Canada.

The first phase of the clinical trial entails administering doses of the vaccine to 40 healthy, adult volunteers, who will be monitored to evaluate the safety and effectiveness of the vaccine. The first doses were given on July 26.

“(Zika) is very much a public health concern,” said Dorothy Peterson, vice president of operations for VGXI Inc.

As of July 27, the Texas Department of State Health Services reported 80 cases of Zika in the state, including 24 in Harris County. An outbreak of Zika has spread over the past year in Latin America and the Caribbean, with some cases of people infected abroad coming to the United States. It is generally contracted through mosquitoes, but can also be transmitted through sexual activity. Infection can cause fever, rash, joint pain

and conjunctivitis, and is of highest risk to pregnant women, since the virus can cause microcephaly, a condition where the baby’s head is abnormally small, and other birth defects.

The vaccines that VGXI Inc. manufactures are different from typical vaccines in that, instead of containing the actual virus, they are made of synthetic plasmids, which are fragments of DNA. The plasmid vaccine is designed to trigger the immune system to respond to the virus. VGXI Inc. has also worked on vaccines for Ebola and Middle East Respiratory Syndrome.

“DNA vaccines have been around for a long time,” Peterson said. “They’re known to be extremely safe. That has been proved over and over again.”

“Development of this Zika vaccine has been the fastest in history in terms of receiving FDA approval for a clinical trial from the initial concept,” said Young K. Park, chief executive officer of GeneOne Life Science, in a release. “We look forward to the approval and availability of an effective vaccine to counter the Zika virus epidemic.”

The timeline on when the vaccine might be available to the public is still uncertain, Peterson said.

“If it stays in the public eye, there’s going to be pressure on the FDA and the government to advance the trials,” she said.

The development of DNA vaccines has become more popular in recent years, Peterson added. VGXI Inc. was founded in 2000, opened its Woodlands facility just a year later and began offering contract plasmid manufacturing in 2008. The company recently completed an expansion of its facilities to create a laboratory designed for smaller-scale contracts.