PENNSYLVANIA, United States, Tuesday August 30, 2016 – A United States-based drug company announced yesterday that it has started a clinical trial of an experimental Zika vaccine in Puerto Rico, where the Zika virus outbreak has been declared a public health emergency.
Inovio Pharmaceuticals Inc. is testing its DNA-based vaccine on 160 adults in the US Caribbean territory.
“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’s President and CEO, Dr. J. Joseph Kim said yesterday.
The Centers for Disease Control and Prevention (CDC) in the US estimates Zika will infect more than a quarter of the Puerto Rican population by year end.
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“The rapid progression of the Zika outbreak in Puerto Rico provides an immediate and unique opportunity to assess a preventive vaccine in a real world setting. This is Inovio’s second human Zika vaccine study. The placebo-controlled trial will test for safety, immune responses and initial evidence of efficacy,” Kim said.
Inovio is developing its Zika vaccine, GLS-5700, with GeneOne Life Science, Inc. and academic collaborators from the US and Canada who are also working to advance Inovio’s Ebola and MERS vaccines through clinical development.
In June, Inovio was the first to commence a human Zika trial, with sites in the United States and Canada. All 40 subjects for the first clinical study have been fully enrolled and dosed. Inovio expects to report results before the end of this year.
There are no approved vaccines or therapies for Zika. While multiple companies and academic groups have announced development plans for Zika virus vaccines, only Inovio and a US government research centre have actually started human clinical studies.
First identified in Uganda, the Zika virus subsequently spread to equatorial Asia and over the past 10 years has rapidly spread through the South Pacific and into South America, Central America, and the Caribbean. Because the Aedes species of mosquitoes that can potentially transmit Zika virus are found throughout the world, there is concern that Zika will continue to spread to new countries and regions.
As of this month, 66 countries and territories reported evidence of mosquito-borne transmission of the Zika virus since 2015, compared to 33 countries stated by WHO in their first Zika situation report in February 2016.