The purpose of this study is to determine whether a new investigational dengue vaccine is safe, well-tolerated, and to see if an immune response against dengue disease will be generated.
Arguably the need for a tetravalent dengue vaccine that will effectively induce immunity against all four dengue serotypes has never been greater. Currently, several different approaches are being taken to develop a protective tetravalent dengue vaccine. These include live-attenuated vaccines derived by serial passage in tissue culture, live chimeric vaccines, recombinant protein vaccines and DNA vaccines. While live attenuated and live chimeric vaccines have shown promise in clinical trials, viral competition with suspected immune interference resulting in imbalanced immune responses and reactogenicity with the occurrence of dengue like symptoms remains a concern. It is imperative that any candidate vaccine produce solid immunity against each of the four dengue virus serotypes. Failure to do so may place the recipient of the vaccine at risk for developing severe dengue disease (dengue hemorrhagic fever/dengue shock syndrome) following exposure to the virus serotype to which there was incomplete protective immunity, resulting in antibody dependent enhancement due to the presence of non-neutralizing anti-dengue antibodies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
Low dose delivered intramuscularly on Study Days 0, 30 and 90
Low dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90
High dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90
Walter Reed Army Institute of Research and Clinical Trial Center (WRAIR CTC)
Silver Spring, Maryland, United States
Number of participants with adverse events (AEs) or serious adverse events (SAEs)
All AEs and SAEs will be recorded during the entire duration of the study, or up to 360 days.
Time frame: Up to Day 360
Percent of subjects (in each group) achieving tetravalent ELISA IgM seroconversion
From date of first vaccine dose until seroconversion is achieved, up to 360 days.
Time frame: Days 0-360
Percent of subjects (in each group) achieving tetravalent seroconversion, by dengue plaque reduction MN50 titer
From date of first vaccine dose until seroconversion is achieved, up to 360 days.
Time frame: Days 0-360
MN50 titer 1 month (Study Day 120) and Study Days 180 and 270 after vaccine regimen is complete
Time frame: Following completion of study days 120 and 180 and 270 days after vaccine regimen is complete
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