Non-Therapeutic Protocol

SENDAI: A Phase I Study of Unmodified Live Intranasal Sendai Virus Vaccine in Children and Toddlers: Assessment of Safety and Immunogenicity

Type of Protocol/Clinical Study

Associated Infectious Diseases Studies : Croup

Description

Croup is an illness of young children that is caused by a virus. With this illness, the child has fever, cough, and hoarseness. Although the illness usually gets better in 2 to 4 days, some children may be put in the hospital and a few infants may require an intervention to help their breathing. This illness is most often caused by a virus called parainfluenza virus type 1, but it can be caused by other viruses. The experimental vaccine that is being investigated in this study is intended to try to prevent croup caused by parainfluenza virus type 1.

Currently, there are no vaccines to prevent this virus, or medications available to treat the illness once infection has occurred. This research study is testing a new experimental live-virus vaccine that is given by placing liquid drops in the nose. The Sendai virus looks a lot like the virus that causes croup, but it has never been found to cause illness in people. Previous studies in animals have shown that the vaccine provided protection against the croup virus, and did not cause illness. Many people have been exposed to the Sendai virus, but no one has been known to get sick. Several healthy adults have been given the Sendai virus vaccine being studied, and they did not experience any serious side effects or illness.


Objectives


Eligibility

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Principal Investigator

Elisabeth Adderson, MD