UCI graduate Chen Cao became the first of 35 individuals to be vaccinated in NantKwest Inc. and ImmunityBio’s phase 1 clinical trial for COVID-19. This trial is only happening at Hoag Memorial Hospital Presbyterian in Newport Beach, CA.
According to the WHO, there are 44 vaccine candidates in clinical evaluation worldwide and another 154 in preclinical evaluation. Most are targetting the coronavirus’ signature spike protein, which leads to its name “corona,” meaning “crown” in Latin.
NantKwest/ImmunityBio’s vaccine also does the same, but it also targets structures within the virus’ cytoplasm called nucleocapsids that have been shown to stimulate T-cell responses.
Philip Robinson, Hoag’s medical director of infection prevention and principal investigator for the vaccine trial, states, “This vaccine is novel because it stimulates the second arm of the immune system, the cell-mediated immunity, the T-cell response.”
Based on SARS-CoV 1, he added that patients who developed that T-cell and cellular immune response have long-lasting immunity that can be measured 17 years after they got infected. T-cell responses are more durable than antibody responses activated by the spike protein alone and develop a much longer-term immunity, the company states.
This vaccine’s dual-edged approach is a “key advantage” that could also prevail in mutations in the spike proteins, which might reduce the efficacy of “S-only” vaccines moving forward. There are several other features that the NantKwest/ImmunityBio vaccine has that is generating enthusiasm.
While several vaccine candidates are using adenoviruses — which cause the common cold — to transfer the coronavirus’ genetic material into the human body to hopefully induce an immune response, however, there’s a potential risk that the body’s immune systems could recognize the cold virus and attack before it can complete its task. This vaccine overcomes this challenge by making deletions to the adenovirus that render it invisible, Robinson said.
Similar to other vaccine candidates, this one will consist of two shots, three weeks apart. But apart from many others, it won’t need to be stored in frigid temperatures, which can pose significant logistical challenges.
Instead, it just requires standard refrigeration and can remain viable at room temperature “for quite a long time,” Robinson said. Down the line might also be delivered by mouth or by nasal spray, rather than just by injection, making administration even easier.
Last Wednesday, five volunteers received their first injections at Hoag, and five more will get their first injections this week, according to Deborah Fridman, Hoag’s director of clinical research. There will be a pause after each set of 10 to review the safety, side effects, and immune system reactions.
This phase 1 trial’s primary goal is to confirm the vaccine’s safety and induces immunity, Fridman said. If proven successful, it will expand into phases 2 and 3 next year, recruiting hundreds, and then thousands, of participants.
Hoag Hospital has participated in more than 20 COVID-19 clinical trials since caring for the state’s first known COVID-19 patient in January. Hoag has given patients access to advanced therapies and innovative treatments, officials said. Though, this vaccine is its first COVID-related vaccine trial.
The hospital has expanded its research department in recent years. Hoag has a relationship with Los Angeles County-based NantKwest, Inc., and ImmunityBio is the only Orange County hospital. It is the only nonacademic institution to offer the companies’ phase 2 immunotherapy clinical trial for solid tumors.
Patient No. 1 Chen Cao must report any side effects to Hoag immediately. She has a diary to record how she’s feeling and will return regularly for evaluation and blood draws.
Anyone interested in participating should email [email protected].
Sources:
- https://www.ocregister.com/2020/10/21/hoag-memorial-selected-as-trial-site-for-promising-covid-19-vaccine/
- https://www.who.int/docs/default-source/coronaviruse/novel-coronavirus-landscape-covid-19cc0232c16129498983a6a0e30ca94000.pdf?sfvrsn=87aa8dc9_1&download=true
- https://nantkwest.com/immunitybio-study-shows-positive-t-cell-and-antibody-immune-responses-to-its-covid-19-vaccine-candidate-that-targets-both-spike-and-nucleocapsid-virus-proteins/
- https://www.hoag.org/news/clinical-trial-for-pancreatic-cancer-patients2/
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