BETHESDA, Md. – Naval Medical Research Command (NMRC) staff recruited 129 volunteers to participate in a phase 1, first-in-human, FDA clinical trial for a Staphylococcus aureus (Staph) treatment at the command’s Clinical Trials Center (CTC).

The trial, consisting of military and civilian volunteer participants, marks the CTC’s largest participant group to date.

This double blind, placebo-controlled trial is being conducted to evaluate a Staph vaccine, designed to reduce the risk of skin and soft tissue infections, as well as other illnesses that affect U.S. service member readiness.

“Staph aureus is a very common bacteria that many of us are already colonized with, meaning it’s living on us, but is not causing disease,” said Cmdr. Javier De Luca-Johnson, the principal investigator on the trial. “But when infection does occur, an illness from Staph aureus can result in time lost from work and hospital visits, impacting military readiness.”


“Our warfighters working in close quarters, whether in training environments or deployed on ships, are at risk for contracting and spreading this bacterium,” he added.

A double-blind, placebo-controlled trial means that neither the researchers nor participants know who is receiving the treatment, versus the placebo. This method allows researchers to evaluate if the treatment is performing as expected.

Phase 1
The first phase of a clinical trial for a new product ensures the treatment it is safe. For the Staph trial, participants are injected with two doses of the vaccine, 1 month apart, with subsequent safety follow-ups conducted over the following 7 months. This allows researchers to evaluate the safety of the vaccine by monitoring for potential adverse events, including injection site reactions, as well as anticipated and unanticipated side effects.
If a treatment is deemed safe following the completion of phase 1, trials will move to phase 2.

Phase 2
This phase consists of multiple cycles of testing to confirm that the treatment works as intended. In this case, researchers will evaluate if the vaccine is having the desired effect on participants and if there are any adverse effects that result from the treatment.

Phase 3
In phase 3, treatments are tested in a larger pool of people to evaluate its effectiveness compared to existing standard or experimental treatments. If successful, this phase culminates in the formulation of a treatment into a marketable product.

The Staph vaccine trial is currently in phase 1. As researchers prepare for phase 2, they hope to find a preventative solution for people who have experienced recurring infections after treating Staph with antibiotics. Those who contract Staph can become increasingly susceptible to future infections. MRSA (methicillin-resistant Staphylococcus aureus) is a common antibiotic-resistant type of Staph infection that can cause various illnesses and be fatal in some cases.

NMRC’s Clinical Trial Center, located at Naval Support Activity Bethesda, is the Navy’s only dedicated human clinical trials center, testing drugs and vaccines before they are licensed. The CTC is overseen by Navy personnel, and does research on behalf of U.S. Sailors.

“We are active-duty Navy physicians who have been on deployments, worked with the fleet and we’re translating that personal connection to our research, to advance warfighter health,” he said. “The successful completion of this trial will be transformative to bolstering warfighter health, because this bacterium has become increasingly antibiotic resistant.”

The CTC evaluates vaccines, therapeutics, prophylactics in human subjects to advance products from the laboratory to the front line and maximize the medical readiness of the warfighter. NMRC CTC is located at Naval Support Activity Bethesda, Building 17B (2nd floor). If you would like to participate or have any questions, please contact the center at 301-295-4735 (call) or 301-233-9640 (text), or via e-mail at usn.nmrc.ctc@health.mil to schedule an appointment.

NMRC, headquarters of Navy Medicine Research & Development, is engaged in a broad spectrum of activity from basic science in the laboratory to field studies in austere and remote areas of the world to investigations in operational environments. In support of Navy, Marine Corps and joint U.S. warfighter health, readiness and lethality, researchers study infectious diseases, biological warfare detection and defense, combat casualty care, environmental health concerns, aerospace and undersea medicine, operational mission support and epidemiology.