Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3-3'Ddelta30) in Healthy Adults
Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to evaluate the safety of and immune response to a new dengue virus vaccine in healthy adults.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||A Phase I Dose Comparison Study of the Safety and Immunogenicity of rDEN3-3'Ddelta30, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 3|
- Safety and immunogenicity, as assessed by neutralizing antibody titers [ Time Frame: At 4 weeks and 6 weeks after vaccination ] [ Designated as safety issue: Yes ]
- Frequency of vaccine related adverse events as graded by severity [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Frequency, quantity, and duration of viremia after a single dose of vaccine [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Number of vaccines infected with rDEN3-3'D4delta30 [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Infectivity rates, safety, and immunogenicity of a single dose of rDEN3-3'D4delta30 vaccine [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Durability of antibody response [ Time Frame: At 26 Weeks after vaccination ] [ Designated as safety issue: No ]
- Obtain an estimate for the Human Infectious Dose-50% (HID50) idf dose dependent infectivity is observed [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
One subcutaneous vaccination (10^3 dose of vaccine) of rDEN3-3'D4delta30 vaccine into the deltoid region of either arm.
Live attenuated 10^3 dose of rDEN3-3'D4delta30 vaccine.
One subcutaneous vaccination (10^5 dose of vaccine or placebo) of rDEN3-3'D4delta30 vaccine into the deltoid region of either arm OR one subcutaneous vaccination (10^1 dose of vaccine or placebo) of rDEN3-3'D4delta30 vaccine into the deltoid region of either arm.
Live attenuated 10^5 dose of rDEN3-3'D4delta30 vaccine.Biological: rDEN3-3'D4delta30
Live attenuated 10^1 dose of rDEN3-3'D4delta30 vaccine.
Dengue viruses cause dengue fever and the more severe dengue hemorrhagic fever/shock syndrome. More than 2 billion people living in tropical and subtropical regions of the world are at risk of dengue virus infection, which is the leading cause of hospitalization and death in children in several tropical Asian countries. This study will evaluate the safety and immunogenicity of a live attenuated dengue virus vaccine called rDEN3-3'D4delta30. This vaccine is derived from rDEN4delta30, another dengue virus vaccine candidate that has been shown to be safe and immunogenic in Phase I and II trials in healthy adults.
There will be two groups in this study. Participants in Group 1 will be randomly assigned to receive rDEN3-3'D4delta30 vaccine or placebo at study entry. The dosing for Group 2 will be determined by a safety review of all participants in Group 1. If less than 90 % of the Group 1 participants seroconvert to DEN3 participants in Group 2 will receive a higher dose of rDEN3-3'D4delta30. If at least 90 % of Group 1 participants seroconvert to DEN3, participants in Group 2 will receive a lower dose of rDEN3-3'D4delta30.
All participants will be required to monitor their temperature three times each day for the first 16 days following each vaccination. Study visits will occur 30 minutes following each vaccination and every other day after vaccination until Day 16, followed by four additional visits at selected days through Day 180. Blood collection, vital signs measurement, and a targeted physical exam will occur at each study visit. Some participants will be asked to undergo a skin biopsy or additional blood collection at selected visits.
|United States, District of Columbia|
|Center for Immunization Research, Johns Hopkins School of Public Health|
|Washington, District of Columbia, United States, 20037|
|United States, Maryland|
|Center for Immunization Research, Johns Hopkins University of Public Health|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Anna Durbin, MD||Center for Immunization Research (CIR), Johns Hopkins School of Public Health|