Expired Study
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Clinical Trial 12490

Silver Spring, MD 20910

Study Summary:

In this study, we are testing a vaccine against norovirus, a virus that causes vomiting and diarrhea. The vaccine is given by an injection ("a shot") in the muscle of your arm. This vaccine is called the IM Norovirus Bivalent VLP Vaccine and it is an investigational vaccine. This means that it is still being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration. Currently 48 volunteers have received this vaccine with no significant side effects related to the vaccine. Our main goals are:

1) to find the side effects of giving IM Norovirus Bivalent VLP Vaccine in the muscle of the arm;
2) to study the body's responses to the vaccine.

What is Norovirus?

Norovirus is one of the most frequent causes of diarrhea. Illness can be severe and includes primarily vomiting and diarrhea. According to the Centers for Disease Control, 23 million cases of norovirus occur each year in the U.S. alone. These viruses are also a common cause of outbreaks in developing parts of the world, where diarrhea is a leading cause of death in young infants. Older populations living in nursing homes and assisted living facilities are at a risk of norovirus as well. This is similar to what is seen in cruise ships or in deployment settings. There is currently no vaccine licensed to prevent norovirus.

What happens during the Study Period?

If you are eligible and decide to participate, you will be randomized to receive the vaccine dose or a placebo. You will receive a shot on Day 0 and on Day 28. You will be asked to return to the clinic on Day 7, Day 21, Day 28 (2nd study injection), Day 35, Day 56, Day 180, and Day 393 for follow-up. A telephone follow-up will also be done on Day 265.

Qualified Participants Must:

• Be generally healthy
• Be 18-49 years of age
• Not be pregnant or breast-feeding
• Not have Diabetes, Heart diseases, Hypertension, Liver diseases, cancer, unconsciousness and seizures
• Not have allergies to any component of the vaccine including MPL (Monophosphoryl lipid A) and AlOH (aluminum hydroxide)
• Not have participated in any previous norovirus vaccine and challenge study
• Not have any condition associated with chronic immune deficiency
• Not have a history of psychiatric hospitalization, alcohol abuse, or illicit drug use in the prior 5 years
• Not have any history of receiving immunoglobulin or other blood products within the last 3 months

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.