Clinical Trial: Safety Study of a Vaccine (DENV-1 PIV) to Prevent Dengue Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1 Trial of the Walter Reed Army Institute of Research (WRAIR) Dengue Virus Serotype-1 Purified Inactivated Vaccine (DENV-1 PIV) in Flavivirus Antibody Naïve A

Brief Summary: This is a phase 1 study to evaluate the safety of a vaccine (DENV-1 PIV) for the prevention of dengue fever.

Detailed Summary:

DENV infections can cause self-limited but incapacitating acute illness lasting four to seven days. The illness is characterized by fever, headache, severe pain in muscles, joints, pain behind the eyes, and a rash. DENV infection can be complicated by the development of hemorrhagic fever (DHF) or shock syndrome (DSS), which is manifested by plasma leakage and a bleeding diathesis or frank hemorrhage. DHF is fatal in at least 0.5% of pediatric cases but rarely in adults. People, particularly children, living in hyper-endemic areas who have antibodies from an earlier dengue infection with one serotype are at increased risk for DHF if subsequently infected by another dengue virus serotype.

Currently, no specific anti-viral therapy exists. Therapy is largely supportive. Mosquito control has failed to prevent dengue transmission; therefore, prevention of dengue through vaccination is an important objective of the World Health Organization (WHO) and many national governments, including the United States.


Sponsor: U.S. Army Medical Research and Materiel Command

Current Primary Outcome:

  • Number of subjects with solicited adverse events (AEs) from study day 0 to 90 [ Time Frame: Up to 90 days ]
  • Number of subjects with unsolicited AEs from study day 0 to 90 [ Time Frame: Up to 90 days ]
  • Number of subjects who experience serious adverse events (SAEs) during the study period [ Time Frame: Up to 360 Days ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of subjects with a change in geometric mean titer of neutralizing antibody to DENV types 1,2,3, and 4 [ Time Frame: Up to Day 28 ]
  • Number of subjects with a change in geometric mean titer of neutralizing antibody to DENV types 1,2,3, and 4 [ Time Frame: Up to Day 90 ]


Original Secondary Outcome: Same as current

Information By: U.S. Army Medical Research and Materiel Command

Dates:
Date Received: December 16, 2011
Date Started: December 2011
Date Completion:
Last Updated: April 21, 2015
Last Verified: April 2015