A Phase 1 interventional study of DENV-1 PIV, 2.5 µg and DENV-1 PIV, 5 µg in Dengue Fever, sponsored by U.S. Army Medical Research and Development Command. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-22.
Sponsored by U.S. Army Medical Research and Development Command · Phase 1, Interventional, and Prevention
This is a phase 1 study to evaluate the safety of a vaccine (DENV-1 PIV) for the prevention of dengue fever.
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.
279 studies on the registry are indexed under Dengue; 45 are open to participants now.
This study's enrollment of 20 is below the median of 123 across 195 interventional studies indexed under Dengue.
Browse Dengue studies →U.S. Army Medical Research and Development Command is the lead sponsor of 151 studies on the registry; 8 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: DENV-1 PIV, 5 µg
Biological: DENV-1 PIV, 2.5 µg
2.5 µg Purified Inactivated Virus (PIV) in a volume of 0.5 mL administered via intramuscular injection on Study Days 0, and 28 (±4 days)
5 µg Purified Inactivated Virus (PIV) in a volume of 0.5 mL administered via intramuscular injection on Study Days 0, and 28 (±4 days)
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
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
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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U.S. Army Medical Research and Development Command