A Phase II Trial of a WRAIR Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy US Adults
This descriptive study will evaluate the safety and immunogenicity of 3 different formulations of the WRAIR dengue vaccine compared to a placebo.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
|Official Title:||Phase II, Randomized, Observer-Blind, Single Center, Controlled Study of Two Doses of Various Formulations of WRAIR Live Attenuated Tetravalent Dengue Vaccine Compared to Placebo Control Administered on 0-6-Month Schedule, to Healthy Adults|
- Occurrence of any, and grade 3 solicited adverse events (AEs) within 21 days follow-up after dose 1 of study vaccine;
- N antibody (GMT) to DEN serotypes 1, 2, 3 and 4, 30 and 90 days after the last study vaccine dose
- Safety endpoints
- Occurrence of any, and grade 3 solicited adverse events (AEs) within 21 days follow-up after dose 2 of study vaccine;
- Occurrence of each type of any and grade 3 solicited AE within the 21-day solicited follow-up period after each dose;
- Occurrence of unsolicited AEs within 31 days (days 0-30) after any study vaccine dose;
- Occurrence of serious adverse events (SAEs) throughout the entire study period;
- Occurrence of alert values for safety laboratory determinations within 31 days after each vaccine dose.
- Occurrence of abnormal findings at DEN physical examination after each vaccine dose
- Occurrence of suspected and confirmed dengue throughout the entire study period
- Immunogenicity endpoints
- N antibody titer above the assay cut-off, to each DEN serotype, after each dose;
- N antibody titer above the assay cut-off, to all dengue serotypes after each dose;
- N sero-response to each DEN serotype after each dose
- N antibody titer to each DEN serotype after vaccine dose 1
- Occurrence of measurable dengue viremia at specified time points following each vaccine dose.
|Study Start Date:||January 2006|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Subjects will be randomized into one of 4 groups. One group will receive a placebo vaccine and the others will receive one of 3 different dengue vaccine formations. Each subject will receive two doses six months apart. Study subjects who elect to participate in a mosquito transmissibility component of the study will undergo mosquito feedings during each of the two assigned follow-up visits after vaccine dose 1. All subjects will have 11 venipunctures during 11 visits (i.e., screening plus 10 study visits) over a period of nine months.
A third (booster) dose of post transfection F17 or F19 will be administered approximately 5 to 12 months after dose 2 to all subjects who received one of these formulation for their first two doses. Volunteers will return for a single visit 6 months after receiving their booster dose (long term follow-up)
|United States, Maryland|
|Walter Reed Army Institute of Research|
|Silver Spring, Maryland, United States, 20910|
|Principal Investigator:||Stephen J Thomas, MD, FACP||Walter Reed Army Institute of Research (WRAIR)|