Researchers at Silver Spring-based Walter Reed Army Institute of Research off of Brookville Road have begun a Phase 1 clinical trial of a new type of COVID-19 Vaccine, and area residents can help.
WRAIR is currently enrolling volunteers for Phase 1 to look at safety in humans, which is the primary purpose of this phase of the trial, along with generating the immune response the researchers expect to find, according to Dr. Paul Scott, deputy director of the WRAIR Emerging Infectious Diseases Branch and lead WRAIR’s ongoing COVID-19 vaccine trial.
The vaccine takes a novel approach developed and manufactured at WRAIR that is different from the other vaccines currently in use.
It was created by co-inventors Dr. Kayvon Modjarrad, director of the Emerging Infectious Diseases Branch at WRAIR who leads the Army’s COVID-19 vaccine research efforts, and WRAIR structural biologist Dr. Gordon Joyce, an employee of the Henry M. Jackson Foundation for the Advancement of Military Medicine, which is providing support for the work.
“The vaccine is a combination of two things,” Scott said. “One is called an immunogen. That’s the component of the vaccine that’s intended to. . .promote a response. It also has a second component, which is an adjuvant. It’s intended to boost your immune [system’s] response beyond what would be just the immunogen. The two work together.”
Pre-clinical studies “elicits broad neutralizing antibody responses that exceed those observed for other major vaccines and rapidly protects against respiratory infection and disease in the upper and lower airways and lung tissue of nonhuman primates,” according to a summary of a prepared paper on the trials.
The immunogen itself is a spike ferritin nanoparticle, the structure of which Scott likens to a soccer ball with its symmetrically arranged interlocking panels.
Researchers were able to attach the spike proteins, which is the means of infection common across these vaccines (see illustration of the virus), Scott said, to be delivered in a different way.
It is set in a very ordered, attached array, and “the immune system appears to like that.”
“The spikes are just sticking out so that the immune system is just repeatedly seeing each particle,” Scott said. “It gives a very specific trigger for the immune system to then respond in a very vigorous way.”
And specific to this type of protection, the adjuvant boosts that response, he added.
The researchers are looking for 72 volunteers for the trial. They must be between 18 and 55 years old, never have been infected by COVID-19, and have not been vaccinated, which Scott said was an increasing narrow population. As of April 26, 24 will have enrolled.
They will divide the 72 into three groups of 24 each. The first group will receive a lower dose with three shots spaced out over six months—when they enroll, one month later, and six months later.
“The second group is going to be an increased dose, the same schedule of three shots,” Scott said. The last group will get two vaccinations, one the day they enroll and one six months later.
They’ll be looking for how long the protection lasts, and whether one dose provides protection, versus two or three.
Half of each group will get the vaccine and half will receive a placebo. It will be a double-blind study where neither patients nor researchers will know which volunteers get a placebo and which get a vaccine.
The facility should not be confused with the Bethesda hospital complex that includes “Walter Reed” in its name. It is, rather, part of the Frederick, Md.-based Fort Detrick command structure. It has a saying, “Soldier Health, World Health,” denoting how the researchers share information with the world. In this case, that would include potential manufacturers of the vaccine.
“We have to get to a point where we have sufficiently compelling information that invites those partnerships,” Scott said.
They will begin analysis of the data from this trial less than two months from now.
“We don’t wait until the full study is done to say, ‘Oh, that looks pretty good,’” he added. “There’s too many important questions, too much need for us to try and address [for us] to wait that long.”
Ultimately, the researchers are optimistic that the nanoparticle platform offers enough flexibility to give broader coverage against coronavirus variants, any others that develop, and any new coronaviruses that turn up in the wild, as well as the whole family of SARS-CoV-2 variants and the SARS-CoV-1 virus.
But the researchers can’t do it alone.
“We rely on the community to do this work,” Scott said. “We can’t do research without individuals who are willing to donate their time to support research.”
WRAIR has a number of advertising initiatives targeting potential volunteers and a community advisory board, he said, “members of the community that engage with all the diversity of this rich area we live in to try to understand what are the issues, what are the barriers, what are the interests of the community and how might we work and partner together to do research, because ultimately, what we bring and develop here is going to be shared with everyone.”
Photos courtesy Defense Visual Information Distribution Service published under DVIDS guidelines. Lab photo by Shawn Fury. Injection photo by Mike Walters