Clinical Trial 13596

Silver Spring, MD 20910


Study Summary:

Background:

This study involves an experimental dengue vaccine. Dengue is a common infection affecting travelers to many areas of the world, including Southeast Asia, Central America, South America 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 of this, the military is trying to develop a vaccine to protect against dengue.

This study involves an experimental dengue vaccine. This is the first time that this dengue vaccine will be used in humans. It will take place at a clinic-type facility in Silver Spring, Maryland. The vaccine will be given in your shoulder using a needle and blood samples will be collected to look at your body’s response. The goals of this study are to determine if the vaccine is safe and how your body responds to the vaccine.


Duration:

This study will last about 200 days 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 2 doses of vaccine. After each injection, there will be follow-up visits. There will be a total of 10 scheduled clinic visits (not including the initial screening) and 2 telephone call sessions.


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, or 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 in a second group of volunteers if the low dose is safe.

Based on experience with similar vaccines, mild reactions are expected. These generally include tenderness, redness and swelling at the injection site. These reactions will most likely resolve on their own within a few days. You may also experience other reactions, such as headache, a low fever, or flu-like symptoms. 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:

• Qualified participants must meet the following requirements to participate in this study:

  • Volunteers must be at least 18 and not older than 50.
  • Volunteers must be in good health and have no significant current or past diseases.
  • Volunteers must not have had an infection or been vaccinated against Japanese Encephalitis, Yellow Fever, West Nile, or dengue virus.
  • Active duty military members need a signed approval memo from their supervisor to participate.
  • Volunteers must have access to the Naval Medical Research Center and Walter Reed Army Institute of Research (WRAIR) in Silver Spring, be willing to attend all of the required visits over approximately 200 days (including screening), and be willing to refrain from participation in any other clinical studies involving investigational drugs or vaccines while participating in this study.
  • Volunteers must agree to not become pregnant or breastfeed during the study and also be willing to use a reliable form of contraception during the study
  • Volunteers must not have donated or received blood, blood products, or plasma within 90 days prior to starting the study or plan on donating blood or plasma during the study.
  • Volunteers 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 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.