Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) 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 test 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, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Phase I Study of the Safety and Immunogenicity of rDEN1delta30, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 1|
- Determine the frequency of vaccine related AEs for each dose graded by severity [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Determine the amount of dengue 1 neutralizing antibody induced by the vaccine [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]
- To assess the durability of the antibody response [ Time Frame: At Day 180 ] [ Designated as safety issue: No ]
- To assess the frequency, quantity, and duration of viremia in each dose cohort studied [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- To compare the T cell mediated immune response against dengue viruses of those volunteers infected with the rDEN1delta30 vaccine virus with that of uninfected volunteers and placebo recipients [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- If both doses of vaccine are administered, to compare the infectivity rates, safety, and immunogenicity between dose groups [ Time Frame: At study completion ] [ Designated as safety issue: No ]
- To evaluate the immunopathological mechanism of vaccine-associated rash in those volunteers who are willing to undergo skin biopsy [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Study Completion Date:||November 2005|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
One subcutaneous vaccination with rDEN1delta30 vaccine (10^3 PFU dose) into the deltoid region of either arm.
Live attenuated rDEN1delta30 vaccine
One subcutaneous vaccination with rDEN1delta30 vaccine (10^5 PFU dose) into the deltoid region of either arm. This arm may enroll after Arm 1 depending on the effect of the vaccine on subjects in Arm 1.
Live attenuated rDEN1delta30 vaccine
Placebo Comparator: 3
One subcutaneous vaccination with placebo into the deltoid region of either arm.
Placebo for rDEN1delta30
More than 2 billion people living in tropical and subtropical regions of the world are at risk of dengue virus infection. Dengue viruses cause dengue fever, as well as the more severe dengue hemorrhagic fever/shock syndrome, and dengue virus infection 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 called rDEN1delta30, which is derived from the Western Pacific DEN1 serotype.
This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive rDEN1delta30 or placebo at study entry. Cohort 2 will begin only after safety review of all participants in Cohort 1. Participants in Cohort 2 will receive a higher dose of rDEN1delta30 or placebo.
After vaccination, participants will be asked to monitor their temperature every day for 16 days. Study visits will occur every other day after vaccination until Day 16, followed by 4 additional visits at selected days through Day 180. Blood collection 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, Maryland|
|Center for Immunization Research, Johns Hopkins School of Public Health|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Anna Durbin, MD||Center for Immunization Research, John Hopkins School of Public Health|