SILVER SPRING, Md. — The Navy is making waves — but not only on the high seas.

Doctors and scientists are pioneering their way to the top of medical research, and a group of Navy physicians might hold the key to the first DNA-based vaccine before the Food and Drug Administration for approval.

If it works, that is.

The Navy’s DNA-based vaccine to guard against anthrax has been successful in mice and rabbits and scientists are moving on to the primate phase, said Navy Dr. (Capt.) Al Mateczun, in charge of the Biological Defense Research Directorate at the Naval Medical Research Center in Silver Spring, Md.

They hope to begin human trials by next year, he said during a recent interview in his first-floor office. "I genuinely think that’s possible," he said of the rapid time line.

Success in animals doesn’t guarantee the DNA vaccine will work in humans because of varying ways in which immune systems develop, he said. "We don’t know, but we think this is going to work really well," Mateczun said. DNA is a chemical structure that forms chromosomes. A piece of a chromosome that dictates a particular trait, like hair color, is called a gene.

An upshot to a vaccine developed from DNA is that it produces few, if any, side effects — and might mute critics who say the current anthrax vaccination program is unsafe, he said.

"Turns out there are few side effects. In fact, I don’t know of any specific ones. ... It appears to be pretty safe," Mateczun said.

"But we gotta get it to work first. If we get it to work, it would not be limited to the military. If the FDA approves it as a vaccine, it could be the first FDA DNA-based vaccine," said the 24-year veteran.

To create the current anthrax vaccine, the bacteria is fermented out and grown in a "soup," Mateczun said.

"You take the soup and do certain things to it and you immunize people with that," he explained — as best he could in layman’s terms. "It’s got components of anthrax to give you immunity."

With the DNA vaccine, the bacteria’s DNA instead of the "soup" is injected. It would be done in two or three shots instead of the current six shots. It can be mass-produced in a fraction of the time. Traditional vaccines usually take years to develop and can be difficult and costly to make, Mateczun said. They need refrigeration, and usually can’t be mixed to inoculate against more than one disease at a time.

Mateczun developed the research with Navy Capt. Darrell Galloway, a Navy Reservist who worked at Ohio State University at the time of discovery and now is full-time active duty. Because of Galloway’s connection to the school, both the Navy and university hold a U.S. patent on the DNA anthrax vaccine.

As if the research itself didn’t keep the scientists busy, Mateczun and his team of about 40 people invented a rapid hand-held test recently used to detect the deadly strain of anthrax that was mailed to federal buildings. They also deployed a portable lab to New York City, and tested the air for possible anthrax at the Winter Olympics in Salt Lake City.

Two floors above Mateczun at the Naval Medical Research Center, Navy Dr. (Capt.) Daniel Carucci is developing a DNA-based vaccine for malaria.

After about 10 years of work on the project, he is further along in the research and has moved on to the second-stage of human trials — including on himself.

For now, the process of inoculating folks won’t work because it’s not feasible, he said.

In his trials, participants are bitten once a month for six months by dozens of mosquitoes infected with the deadly malaria strain called plasmodium falciparum.

Those mosquitoes have been "radiated," a process that affects the virus’ DNA and prevents it from leaving a human’s liver and taking a deadly course through the bloodstream, he said.

"I know of few people who would want to go through that," said Carucci, 43.

The repetitive exposure to the virus helps humans build up an immunity.

After the six months of exposure, subjects are bitten by unradiated infected mosquitoes — and none have developed signs of malaria, he said.

Last year, the Navy received a U.S. patent on all DNA vaccines against malaria.

NEW YORK – An Ohio State University professor is part of a team that developed a new protocol that the U.S. Navy now uses to detect biowarfare (BW) agents, such as anthrax, aboard its ships.

"Until mid-2002, the only equipment to detect biological agents that warships had were the sailors themselves," said Michael Boehm, an associate professor of plant pathology at Ohio State and a lieutenant commander in the U.S. Naval Reserve.

"The military was ill-prepared to deal with what might happen if a 37-cent letter filled with anthrax or smallpox was opened on a ship at sea."

Boehm was called to active duty shortly after September 11, 2001, to help the Navy develop an inclusive biowarfare agent detection program. In late 2001, he headed for the Naval Medical Research Center's Biological Defense Research Directorate (BDRD) in Silver Spring, Md. Boehm's active duty stint ended in February 2003, and he returned to Ohio State.

He and his colleagues at BDRD developed, implemented and trained Navy personnel in how to sample, test and respond to possible biowarfare attacks by agents such as anthrax and smallpox that, this past spring, the Navy adopted as a standard operating procedure for detecting the presence of BW agents. According to Boehm, the plan can be used anywhere there's a suspected BW incident.

Boehm shared his experience in designing the protocol on September 9 at the meeting of the American Chemical Society in New York City. Co-presenters, all with the Naval Medical Research Center's Biological Defense Research Directorate, included [Dr. Alfred Joseph Mateczun Jr. (born 1942)], [Dr. Darrell Ray Galloway (born 1946)], Robert Bull, Joan Gebhardt, Timothy Stello and Richard Gotautas.

The researchers devised a three-tiered biowarfare agent detection system:

Level 1 – presumptive. Armed with portable hand-held assays, which look and function like home pregnancy test kits, trained personnel can determine within 15 minutes to an hour whether or not a suspected BW agent has infiltrated a ship. Developed in the early 1990s for use in Operation Desert Storm, such test kits give users quick results, but also have their limits, Boehm said.

"While these tests are a good, quick prescreen, the only definitive way to determine if the results of the hand-held test are truly accurate is to grow the organisms in a laboratory," he said.

Level 2 – confirmatory. Before the current testing system was in place, ship-bound Navy personnel had to wait 24 to 96 hours before getting a definitive answer on whether or not a suspected pathogen had infiltrated a ship, said Boehm. Suspicious samples were sent to land-based laboratories for testing. Under the new protocol, several warships have installed air filters connected to machines that run polymerase chain reaction (PCR) assays – tests that provide a genetic fingerprint of a biowarfare agent. These air filters "breathe" nearly 70 times the amount of air a sailor breathes.

"With PCR, we could find a single gene copy amid an ocean of pathogen in less than an hour," Boehm said. This kind of quick detection helps medical personnel know how to treat people who were exposed to the pathogen, ideally before those people have a chance to infect others.

Level 3 – definitive. The suspected specimen is sent to BDRD or another national laboratory, such as the Centers for Disease Control and Prevention or the U.S. Army's Medical Research Institute of Infectious Diseases for a full analysis.

"The problem with BW agents is that they come in a variety of forms, such as bacteria, toxins and viruses," Boehm said. "Several of the biggest threats – anthrax and plague – are bacteria and can be grown in a laboratory. But viruses like smallpox can only be grown in special conditions. Toxins can't be cultured."

While the three-tiered protocol was designed for seafaring ships, the same steps can be – and have been – taken to determine the presence of BW agents in buildings and other enclosed structures.

"BDRD used these three highly complementary approaches for detecting biowarfare agents to process more than 16,000 environmental samples collected from key points within Washington, D.C. during the anthrax outbreaks following September 11," Boehm said. Since then he and his colleagues also trained personnel from more than 30 Naval units to conduct confirmatory analyses.

The next step, Boehm said, is to develop a similar detection system for agriculture.

"The kind of system that we put in place for the Navy doesn't exist for training people to detect plant and animal pathogens," Boehm said.