Phase 1 Trial to Model Primary, Secondary, and Tertiary Dengue Using a Monovalent Vaccine
Background: Dengue is a disease caused by a virus transmitted by mosquitoes in tropical and subtropical regions. Dengue is a leading cause of hospital stays and death in parts of Asia and Latin America, and outbreaks have occurred in the US. Currently, only one vaccine is licensed for dengue, but it only protects people who have had dengue before. In people who have never had dengue, that vaccine increases the risk of severe disease. Better vaccines are needed. Objectives: To test a potential new vaccine against dengue. To see if side effects and immune responses are different depending on a person s previous exposure to dengue. Eligibility: Healthy people aged 18 to 59 years. Design: Participants will visit the clinic 11 times in 7 months; 9 of those visits will be in the first 2 months. Two additional visits are optional. Participants will be screened. They will have a physical exam with urine and blood tests. They will complete a survey about their travel history. Participants may opt to have a lymph node aspiration before receiving the study vaccine. An area in the left armpit will be numbed. A needle will be inserted to remove some cells from a lymph node. The vaccine will be injected into the fat under the skin of the participant s upper left arm. Participants will return for a provider visit and blood draws every 3 days for about the first 2 weeks. Then they will return for a provider visit and blood draws after longer intervals up to 7 months. The lymph node aspiration may be repeated at later visits. Participants may opt to return for a last visit after 12 months.
A Phase I Dose Comparison Study of the Safety and Immunogenicity of rDEN3delta30/31-7164, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 3
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.