A local lab on Monday dosed its first human subject with its coronavirus vaccine. Inovio Pharmaceuticals, a Pennsylvania company with a lab in Sorrento Valley, is testing the safety of its product in up to 40 healthy adults. Interim results are expected by summer.
Inovio’s progress is the latest development in the global race to develop a pharmaceutical tool against the pandemic. Another U.S. company already began testing its vaccine last month and several others are just behind it. Researchers in China and the United Kingdom are also moving forward with their candidates.
Inovio lead researcher Kate Broderick said it was a major accomplishment for the staff behind the vaccine to reach this stage in only three months. Scientists began working on it back in January and intended to reach trials by summer but recently upped that to this month.
“For us as a team, it's a huge achievement,” Broderick said. “But I also like to think of it as a massive achievement for the whole global community in general, because this is another step forward towards a solution for the current global COVID-19 outbreak.”
The first of the three required human trials tests for side effects, but Broderick said she’s not expecting any adverse reactions from the injection. She said the biotech firm has previously tested other vaccines, including for MERS, HPV and Zika on about 2,000 participants without safety issues.
“That's not something we've ever seen,” said Broderick, who is the senior vice president of research and development.
She’s more focused on how well the vaccine, which will be administered in two doses four weeks apart, triggers an immune response in the volunteers.
“We’ll be testing their blood for the different antibodies and T-cells that we believe will be crucial to the body’s ability to defend itself against this virus,” she said.
Researchers will take blood samples from the volunteers at testing sites in Philadelphia and Kansas City, Mo. shortly after they receive each dose but also up to a year later, the traditional timeline for a first-stage human trial. But considering the rising numbers of COVID-19 deaths and infections, Broderick said Inovio will examine data after just a few months to ask regulators for special approval to enter stage two.
“Certainly under the circumstances of an outbreak like obviously what we're experiencing today but also other outbreaks that people may have heard of, so Ebola, Zika, MERS — this is very standard process to generate early data and use that as supporting data to move forward,” she said.
The second stage of human trials typically includes hundreds of volunteers to further evaluate the efficacy of the vaccine. Broderick has previously said Inovio could potentially include medical professionals, potentially from San Diego, as testing volunteers to protect them during the pandemic, but that requires approval from regulators.
The county's chief medical officer Dr. Nick Yphantides said he would relay information about the potential opportunity to the region’s health care workers.
“If somebody wants to send in information, we will be more than happy to disseminate that accordingly,” Yphantides said. “Participation of course in any clinical trial is something that is voluntary and would be up ultimately to the individual. But the institution making them aware of that opportunity is certainly something we can coordinate on a regional basis.”
He said under normal circumstances the county would not typically facilitate the involvement of local medical staff in a clinical trial.
Inovio’s vaccines are based on DNA, not the actual virus, which is different from the traditional process. DNA vaccines have been tested in humans but haven’t received regulatory approval for wide public use.
