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

Categories:

Infectious Diseases

Vaccines

Phase I/II

Eligibility Overview:

  • Child is greater than or equal to twelve (12) months and less than twenty-four (24) months.
  • Child has adequate blood, liver and kidney function.
  • Child has no history of lung disease, asthma, and hospitalization for respiratory illness, immunodeficiency, sickle cell disease, or any other serious underlying condition.

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

  • To determine if giving live Sendai virus (in the form of a vaccine) to children through their nose is safe (causes no serious illness).
  • To determine if a child’s body responds to the presence of the Sendai virus by making proteins in the blood called antibodies that can find and kill the croup virus.

Eligibility

  • Child is greater than or equal to twelve (12) months and less than twenty-four (24) months.
  • Child has adequate blood, liver and kidney function.
  • Child has no history of lung disease, asthma, and hospitalization for respiratory illness, immunodeficiency, sickle cell disease, or any other serious underlying condition.

Principal Investigator

Elisabeth Adderson, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.