Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults
Dengue Fever
About this trial
This is an interventional prevention trial for Dengue Fever focused on measuring Dengue Vaccine, Dengue Virus, Dengue Hemorrhagic Fever, Dengue Shock Syndrome
Eligibility Criteria
Inclusion Criteria: Willing to be followed for the duration of the study Willing to use acceptable methods of contraception Good general health Exclusion Criteria: Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study Liver, renal, or hematologic disease Alcohol or drug abuse within 12 months of study entry History of severe allergic reaction or anaphylaxis Emergency room visit or hospitalization for severe asthma within 6 months of study entry HIV-1 infected HCV infected Hepatitis B surface antigen positive Known immunodeficiency syndrome Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical or nasal corticosteroids are not excluded. Live vaccine within 4 weeks of study entry Killed vaccine within 2 weeks of study entry Blood products within 6 months of study entry Investigational drugs or vaccines within 60 days prior to study entry or while currently enrolled in this clinical trial Previously received a licensed or experimental yellow fever or dengue vaccine Surgical removal of spleen History of dengue virus infection or other flavivirus infection Other condition that, in the opinion of the investigator, would affect the participant's participation in the study Pregnancy or breastfeeding Plan to travel to an area where dengue infection is common
Sites / Locations
- Center for Immunization Research, Johns Hopkins School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
1
2
3
One subcutaneous vaccination with rDEN1delta30 vaccine (10^3 PFU dose) into the deltoid region of either arm.
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.
One subcutaneous vaccination with placebo into the deltoid region of either arm.