AUSA NEWS: Army COVID-19 Vaccine to Enter Clinical Trials

A research microbiologist harvests samples of coronavirus in a laboratory at the U.S. Army Medical Research Institute of Infectious Diseases.

Defense Dept. photo

The Army is making progress on its COVID-19 vaccine and is preparing for clinical trials with human test subjects, officials said Oct.14.

Dubbed “spike ferritin nanoparticle,” or SPFN, the effort is one of many coronavirus vaccines that fall under Operation Warp Speed, a government-run project to develop and distribute a coronavirus vaccine quickly.

Kayvon Modjarrad, director of emerging infectious diseases at Walter Reed Army Institute of Research, told reporters that the service has begun testing its vaccine on larger animals. The Army anticipates beginning phase one clinical trials this winter, he said. Clinical trials involve human test subjects. Phase one generally involves a small number of test subjects and is used to determine safety, according to the Very Well Health website.

The vaccine entered manufacturing for clinical-grade production trials last month at a small pilot bioproduction facility, he noted.

“We are currently in manufacturing of our vaccine candidate,” he said during a media call during the Association of the United States Army’s annual meeting, which was held virtually due to COVID-19 concerns. “We have moved from small animals to large animals, meaning gone from mice to monkeys.”

SPFN is a nanoparticle vaccine that uses spike proteins to block infections, Modjarrad explained. Almost all of the efforts that fall under Operation Warp Speed are based around these proteins, he noted.

“What is unique about our approach is that it's an ordered presentation of multiple spike proteins on one particle,” he said. “You have kind of an all-in-one vaccine that addresses all types of coronaviruses within that virus family.”

The service is also using this method to try to anticipate future strains of COVID-19, he noted.

“We are also doing the work to develop recombinant genetically engineered spike proteins that will anticipate future coronaviruses that we haven't even seen yet,” he said. “We're looking at coronavirus spike proteins that haven't only [been] isolated from bat populations.”

The Army has yet to determine whether SPFN will need to be administered as a single or double dose, Modjarrad said.

“We'll have those data in the next few weeks from our animal studies, and then that will inform the final design of our clinical trial,” he said.

Over the last few months, the service has examined the other vaccine candidates to gain insight on animals best suited to the testing, he noted.

“A lot of these vaccines were already going into phase one trial before they were being tested in larger animals,” he said.

Additionally, the service is still participating in the development process of other vaccines under Operation War Speed, he noted. In March, Army Secretary Ryan McCarthy announced that the service was participating in five vaccine tracks with about two dozen candidates.

“We’re also providing our technical expertise to advance those candidates as well as providing our own resources and our sites for clinical evaluation,” he said.

The service may also participate in vaccine distribution, said Lt. Gen. Scott Dingle, surgeon general of the Army and commanding general of Army Medical Command. The distribution process will be led by the Defense Department.

“The Army will execute what the Department of Defense requests us to do to assist with any way possible for vaccine distribution,” he said.

Topics: Army News