BALTIMORE – Hope is high right now for a genetically engineered Zika virus vaccine currently being tested in humans.
“If we saw something, even early on, that we were concerned about, we would stop the trial and re-evaluate it. And that hasn’t happened, so that’s good news,” said Kathleen M. Neuzil, MD, lead investigator of the trial and a professor at the University of Maryland in Baltimore, where she is also director of the Center for Vaccine Development.
Testing of the DNA-based Zika vaccine began in early August. Now that Congress has approved a $1.1 billion funding package, Dr. Neuzil said investigators can rest assured that there is enough funding for the duration of this trial, which ultimately could take 2 years or longer.
Sponsored by the National Institutes of Health, phase I of the trial is being conducted at three U.S. sites, including the University of Maryland’s Vaccine Development Center, the NIH Clinical Center in Bethesda, Md., and Emory University in Atlanta.
Safety and tolerability results from all three sites are expected by year’s end and will inform how to construct phase II, currently set to begin in early 2017. That phase is expected to include a much larger population than the 80 current participants, although the exact numbers are still to be determined, Dr. Neuzil said. Also still unknown is whether phase II will be conducted internationally.
If the vaccine proves effective, it will be a high point in the annals of maternal-fetal medicine, said Christopher Harman, MD, chair of obstetrics and gynecology and director of the division of maternal-fetal medicine at the University of Maryland. “It’s going to become a story where the power of modern medicine has defeated an epidemic that had enormous potential for harm.”
Dr. Harman also predicted that a viable vaccine, combined with infectious disease prevention services globally, will mitigate Zika’s threat to the population, particularly developing fetuses.
In the meantime, there needs to be continued public education about preventing the spread of Zika, as well as rigorous attention to family planning, Dr. Harman said.
“Planned pregnancy is essential,” he said. “This puts the burden on the couple or the woman. Don’t get pregnant if you’re in an endemic area.”
For more about the vaccine trial and how clinicians can counsel patients about the threat of Zika, watch this video recorded at the University of Maryland.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel.
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