A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules of the vaccine. Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of viremia at baseline \[during the screening period or on day of vaccination (Day 0)\], and then on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue neutralizing antibodies in serum were obtained at baseline \[during the screening period or on day of vaccination (Day 0)\], then on Days 30, 90 and 120. The entire duration for each individual subjects participation was approximately 5 months including recruitment and collection of data for primary outcomes (through Day 120).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
140
TDV subcutaneous injection
TDV New Formulation subcutaneous injection
Placebo subcutaneous injection
New Formulation placebo subcutaneous injection
Heart Center of the Rockies
Fort Collins, Colorado, United States
University of Texas Medical Branch
Galveston, Texas, United States
Advanced Clinical Research
West Jordan, Utah, United States
Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported
Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported.
Time frame: Day 0 to Day 104
Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
Time frame: For 30 days after each dose (Up to Day 120)
Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination.
Time frame: For 30 days after each dose (Up to Day 120)
Rate of Seroconversion to Each of Four Dengue Serotypes
Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.
Time frame: Up to 30 days after the last immunization (Up to Day 120)
Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations
Serotype-Specific TDV Viral RNA was assessed for the four dengue serotypes: Dengue-1, Dengue-2, Dengue-3 and Dengue-4 . Only those serotypes and time-points where at least 1 participant had Serotype-Specific TDV Viral RNA Detected is reported.
Time frame: various timepoints up to 30 days after each dose (Up to Day 120)
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes
Time frame: Days 30, 90 and 120 after 1st vaccination
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