She didn’t really peek as the short needle sunk into her arm. It pinched a little, sure, but avoided the muscle, so didn’t pack the punch of a flu shot.
And just like that, recent UC Irvine graduate Chen Cao became the first of 35 people to be vaccinated in NantKwest Inc. and ImmunityBio’s phase 1 clinical trial for COVID-19, happening only at Hoag Memorial Hospital Presbyterian in Newport Beach.
“I want to do something good,” Cao, 25, said Wednesday, Oct. 21.
Around the world, 44 vaccine candidates are in clinical evaluation, and another 154 in preclinical evaluation, according to the World Health Organization. Most target the coronavirus’ signature spike protein, which prompted its name — “corona” means “crown” in Latin. NantKwest/ImmunityBio’s vaccine does that, too, but it also goes, quite literally, deeper, targeting structures within the virus’ cytoplasm called nucleocapsids that have been shown to spark T-cell responses.
“This vaccine is novel because it stimulates the second arm of the immune system, the cell-mediated immunity, the T-cell response,” said Philip Robinson, Hoag’s medical director of infection prevention and principal investigator for the vaccine trial. “What we know, based on SARS-CoV 1, is that patients who developed that T-cell, cellular immune response have very long lived immunity that can be measured 17 years after they got infected.”
T-cell responses are more robust than antibody responses triggered by the spike protein alone, and can form a much longer term immunity, the company says. This vaccine’s double-edged approach is a “key advantage” that could also overcome mutations in the spike proteins, which might limit the efficacy of “S-only” vaccines going forward.
The NantKwest/ImmunityBio vaccine has several other features that generate optimism.
While many vaccine candidates use adenoviruses — which cause the common cold — to carry the novel coronavirus’ genetic material into the human body (hopefully invoking an immune response), there’s a danger that the body’s immune systems recognize the cold virus and attack before it can do its job. This vaccine works around that by making deletions to the adenovirus that render it invisible, Robinson said.
Like many vaccine candidates, this one will require two shots, three weeks apart. But unlike many others, it won’t need to be stored at super-cold temperatures, which can pose great logistical challenges. Rather, it just needs standard refrigeration and can remain viable at room temperature “for quite a long time,” Robinson said. Down the line, it might also be delivered by mouth or by nasal spray, rather than just by injection, making administration even easier.
Five volunteers got their first injections at Hoag on Wednesday, and five more will get their first injections next week, said Deborah Fridman, Hoag’s director of clinical research. There will be a pause after each set of 10 to examine safety, side effects and immune system responses. Anyone interested in participating should email email@example.com.
The primary goal of this phase 1 trial is to ensure the vaccine is safe and induces immunity, Fridman said. If all goes well, it will expand into phases 2 and 3 next year, recruiting hundreds, and then thousands, of people.
Hoag is thrilled to be the home of this trial. Since caring for the state’s first known COVID-19 patient back in January, Hoag has participated in more than 20 COVID-19 clinical trials, giving patients access to cutting-edge therapies and innovative treatments, officials said. This, though, is its first COVID-related vaccine trial, and it’s a biggie.
The hospital has beefed up its research department in recent years, and has a relationship with Los Angeles County-based NantKwest, Inc. and ImmunityBio as the only Orange County hospital, and only nonacademic institution, to offer the companies’ phase 2 immunotherapy clinical trial for solid tumors.
The companies are chaired by Patrick Soon-Shiong, a bioscientist and billionaire businessman who was once a transplant surgeon at UCLA. He also bought the Los Angeles Times and San Diego Union Tribune from Chicago-based Tribune Co., returning them to local ownership.
“It’s very exciting that this hospital will take on this task,” Soon-Shiong told the San Diego Union Tribune in a video explaining how the vaccine works.
Chen, patient No. 1, must report any side effects to Hoag immediately. She has a diary in which she’ll record how she’s feeling, and will return for evaluation and blood draws regularly. She just got her bachelor’s degree in business administration, started a new job, and may be developing T cell immunity, all at the same time.
“I’m honored to be No. 1,” she said, “and I hope this can really be a help.”
Source: Orange County Register