A Phase 1 interventional study of Investigational Vaccine for Dengue Virus Subtype 2 and Placebo in Dengue Virus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-03.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention
Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. This study will test whether a vaccine developed to prevent infection with dengue virus type 2 causes a response in people's immune system and is safe.
Dengue viruses cause approximately 50 million cases of dengue fever and 1.5 million cases of the more severe diseases dengue hemorrhagic fever (DHS) and dengue shock syndrome (DSS) every year. There are four subtypes of the virus, and infection with one offers no protection from infection by the others. In fact, most cases of DHS and DSS occur in people infected by more than one subtype. In areas of the world where multiple subtypes of dengue are common, vaccines must be developed against each of the subtypes of dengue virus. This study will examine the safety and immune response of an investigational vaccine for preventing dengue virus type 2.
Participation in this study will last about 6 weeks. Participants will be randomly assigned to be injected with either the investigational study vaccine or a placebo. Participants will have a five in six chance of receiving the vaccine. The first study visit will take place on the vaccination day, on which participants will undergo a physical examination, blood draw, and pregnancy test and then receive the vaccine. Participants will be given a thermometer and temperature card and be told to record their temperatures three times per day for 16 days after vaccination. Participants will come to follow-up visits every other day for the 16 days after vaccination and then 3, 4, and 6 weeks after vaccination (Days 21, 28, and 42). Assessments completed during these visits will include a questionnaire about how the participant is feeling, pregnancy test, review of temperature cards, blood draw, and physical exam. Blood drawn will be analyzed to check participants' health, determine the amount of vaccine and antibodies in the blood, test markers in white blood cells and genes, and look for proteins that are important for fighting dengue infection.
279 studies on the registry are indexed under Dengue; 45 are open to participants now.
This study's enrollment of 18 is below the median of 123 across 195 interventional studies indexed under Dengue.
Browse Dengue studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
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Exclusion Criteria:
Participants will receive a single dose of investigational vaccine for dengue virus subtype 2.
Biological: Investigational Vaccine for Dengue Virus Subtype 2
Participants will receive a single dose of placebo vaccine.
Other: Placebo
Subcutaneous injection in upper arm of vaccine at dose of 10 plaque-forming units (PFU)
Also known as: rDEN2/4Δ30
Subcutaneous injection of placebo
Immunogenicity of vaccine, as assessed by neutralizing antibody titers
Time frame: Measured at 4 and 6 weeks after vaccination
Safety of vaccine, as assessed by the frequency of vaccine-related adverse events (AEs), graded by severity
Time frame: Measured throughout study
Number of vaccinees infected with this dengue virus subtype 2 (DEN2) candidate vaccine, as defined by either recovery of vaccine virus from the blood of vaccinated participants and/or by seroconversion to DEN2
Time frame: Measured at Days 28 and 42
Frequency, quantity, and duration of viremia
Time frame: Measured after vaccination
Comparison of infectivity rates, safety, and immunogenicity of a single dose of DEN2 vaccine from this trial to those variables on previous trials
Time frame: Measured at study completion
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)