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Clinical Trial 13112

Silver Spring, MD 20910

Study Summary:

This study involves an experimental dengue vaccine. Dengue is a common infection affecting travelers to many areas of the world, including Southeast Asia, Central American, South American and the Caribbean. It is caused by a virus and is transmitted by a mosquito. Dengue can cause fever, tiredness, and even severe bleeding or death. It can pose a threat to military operations, and because this, the military is trying to develop a vaccine to protect against dengue.

This study involves a dengue vaccine that is experimental and has never been given to humans. It will take place at a clinic-type facility in Silver Spring, Maryland. The vaccine will be given in your arm or arms using a needle and blood samples will be collected to look at your body's response. The goals of this study are determine if the vaccine is safe and how your body responds to the vaccine.

Duration: This study will last about 12 months including the time involved for screening. One or two clinic visits are required to see if you qualify for the study. If you are accepted into the study, you will receive 3 doses of vaccine over 3 months. You will visit the clinic 2 days and 7 days after each vaccination. A schedule will be given to you during the screening sessions that details the other days you will need to come to the clinic.

Possible Risks: There are risks associated with receiving this vaccine. This is the first time this dengue vaccine will be given to humans. Parts of the vaccine have been given to animals, and the Food and Drug Administration (FDA) has approved the use of this vaccine for this study.

We will start with a low dose of the vaccine in the first group of volunteers and then increase to a higher dose if the low dose is safe.

Based on experience with similar vaccines, mild reactions are expected. These generally include skin itching, pain at the injection site, and redness. These reactions will most likely resolve on their own within a few days. You may also experience other reactions, such as fever, headache, or tiredness. There may be some risks that are unknown.

After each vaccination you will see a physician in the clinic who will evaluate the number and type of reactions.

Qualified Participants Must:

• Be at least 18 years of age and not older than 50
• Be in good health and have no significant current or past diseases
• Not have had an infection or been vaccinated against Japanese Encephalitis, Yellow Fever, or Dengue
• If active duty military members, need a signed approval memo from their supervisor to participate
• Have access to the Naval Medical Research Center in Forest Glen, Maryland and Walter Reed Army Institute of Research (WRAIR), be willing to attend all of the required visits over 6-9 months, and be willing to refrain from participation in any other clinical studies involving investigational products or devices while participating in this study
• Cannot be pregnant or breastfeeding or anticipate becoming pregnant during the study
• Not have donated or received blood, blood products, or plasma within 30 days prior to starting the study or plan on donating blood or plasma for at least 60 days after the last study vaccination
• Cannot participate if they plan to travel to an area where dengue is common during the study period

Qualified Participants May Receive:

All study-related procedures and study vaccinations are performed at no cost. Participants will be compensated for their time.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.