While researchers continue to push for a COVID-19 treatment, Duke is stepping up to help join the fight.
A team at the Duke Human Vaccine Institute received $7.6 million in federal funds to develop an RNA-based antibody treatment for the prevention of COVID-19. Manufacturing will begin later this year and a Phase 1 clinical trial is on track to begin in early 2021.
“We were able to isolate the genetic material from people who were infected already and then we are injecting the RNA…so that people will passively be given the antibody. They will have protective levels within days as opposed to having to wait weeks to months for a vaccine,” said Professor of Medicine Gregory Sempowski.
He estimates antibodies produced by this treatment could last for one to two months.
Sempowski also leads the DHVI Pandemic Prevention Program, established in 2017. The program was designed to quickly halt outbreaks and protect those at the front lines of pandemic response, often the military or National Guard.
The grant for the antibody research was provided by the U.S. Department of Defense, Defense Advanced Research Project Agency.
The Phase 1 trial, designed to determine safety through dose escalation, will allow 33 healthy adults to receive the antibodies. The researchers will then pick the highest safe dose to test on a greater number of people. Nearly all aspects of the research, production and testing for the trial will take place at Duke, a capability that enables increased efficiency for the trial.
“Phase 1 is always for safety––it's not for efficacy. A secondary endpoint will be: Does the product that we're giving actually produce the antibody in the person?” Sempowski explained.
Although it is similar to a COVID-19 vaccine, the antibody treatment is distinct in several ways.
The RNA-based vaccines currently in development stimulate an immune response by encoding for the spike protein on the surface of the virus, which the immune system recognizes as foreign. The Duke team’s antibody treatment will bypass that process, instead giving the RNA instructions to produce the antibodies right away. Using the RNA delivery method will simplify production, saving both time and money.
Sempowski explained that the experimental antibody treatment will provide users protection within days, but noted that although the power of antibodies eventually fades, vaccines induce a robust memory response that the immune system can use to recognize and fight diseases years later.
According to Sempowski, these new antibodies could also be utilized as a preventive measure for high risk groups.
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“If you were being deployed, we could give you an infusion of this and in a matter of a day or two, you would have some protective levels that would last about a month or so,” he said, “and then you could simultaneously be immunized if a vaccine was out there.”
Sempowski emphasized that the implications of the treatment are not limited to the coronavirus pandemic. He said the program was originally designed as a “universal platform” that can be used as a blueprint for fighting any new disease or pathogen that may emerge in the future.