Hoag Memorial Hospital in O.C. begins first phase of clinical trial for COVID-19 vaccine
There are two reasons Chen Cao decided she would participate in a clinical trial for a potential vaccine for COVID-19: the first being that she was healthy and qualified. The second being, “I’m really sick of COVID right now.”
Cao, 25, was the first patient on Wednesday to be dosed in the first phase of a clinical trial testing a vaccine candidate called hAd5-COVID-19. The vaccine was developed in a collaboration between NantKwest Inc. and ImmunityBio, whose chairman and chief executive officer, Dr. Patrick Soon-Shiong, owns the Los Angeles Times, the Daily Pilot and other newspapers in Southern California.
But, Cao joked she wishes she was the seventh patient dosed.
“They have a number for every patient. I’m 001. I was thinking about getting 007,” Cao said, laughing. “That’s much cooler.”
Hoag Memorial Hospital is the first test site in the U.S. of this particular potential vaccine, which Dr. Philip Robinson, the medical director of infection protection and hospital epidemiology, said contains two proteins from the virus that causes COVID-19.
“The first protein is the outer spike protein. That causes the immune system to develop antibodies, which is good. But, we don’t know how effective they are or how long lived they are,” Robinson said.
“We don’t know at this point how long the immunity lasts just by training the immune system to make antibodies in response to the outer spike protein,” he added. “Then, there is a protein called a nucleocapsid. There’s a lot more of it than the spike protein.
“This vaccine is designed to use that nucleocapsid to train the other side of the immune system,” Robinson said.
“The other side is the cell-mediated immune response,” he added. “That appears to be much more longer lived or provides protection for a much longer time than the antibodies may.”
Robinson said data show tht patients infected with a strain of severe acute respiratory syndrome, SARS, in 2003 still have immunity to the respiratory illness almost 17 years later provided by the cell-mediated immune response, not by antibodies.
“We’re hopeful, in stimulating and training both sides of the immune system, that this vaccine will provide long-lasting immunity against this virus,” Robinson said.
The clinical trial will track 35 participants as part of the first phase but will begin with just 10 patients. Four were given a dose on Wednesday.
The remaining six will be enrolled next week.
Once all 10 participants are given a dose, the data will be passed to an independent data safety monitoring board to evaluate the safety of patients before all 35 participants can be included in the first phase, said Dr. Deborah Fridman, director of clinical research at Hoag.
“A phase one clinical trial is all about safety,” Robinson said.
“These patients that are receiving the vaccine are monitored very closely. For the first part of their monitoring, it’s constant. They’re going to be journaling any symptoms that they have and reporting back to us if they develop any symptoms that concerns them,” he said.
“We’ll be seeing them initially every week as part of our safety monitoring. At the third week, they come back for their second injection.”
Recruitment for the clinical trial began last Thursday, and posters were placed in medical group centers for patients to review as well as on social media. Researchers were seeking nonsmokers between the ages of 18 to 55. Participants were taken on as they called, Fridman said.
“We didn’t want to handpick,” she added.
Cao said she found out through WeChat.
“I figured, ‘Why not?’ My family is overseas in Shanghai and were supposed to attend my graduation this year in July, but because of COVID, all the plans had to be canceled,” Cao said. “I haven’t seen them in two years. I can’t imagine how other people feel about losing their families during this pandemic.
“I thought, ‘If there’s a little thing I can do, I want to do it,’” she said.
She said Thursday she was feeling all right and didn’t feel any significant differences from the day before outside of a little soreness at the injection site. Robinson said the vaccine is being administered through subcutaneous injection for the first phase of the trial.
“Hoag is incredibly excited to be part of this,” Robinson said. “I think everybody realizes that one of the ways out of this pandemic is through a vaccination. Hoag leapt at the opportunity to be the trial site for a vaccine that has such great potential.”
Fridman said participants will be monitored through the first year.
On Thursday, the Orange County Health Care Agency reported 11 new deaths from COVID-19 in the county and 213 more cases of the coronavirus. The total number of cases is 57,848, with 1,434 deaths.
Nguyen writes for Times Community News.
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