Safety of and Immune Response to Two Different Dengue Virus Vaccines in Individuals Previously Immunized Against Dengue Virus
Dengue Hemorrhagic Fever
About this trial
This is an interventional prevention trial for Dengue Hemorrhagic Fever focused on measuring Dengue Fever, Dengue Hemorrhagic Fever, Dengue Vaccination
Eligibility Criteria
Inclusion Criteria:
- Previous vaccination with rDEN1delta30, rDEN2/4delta30(ME), OR rDEN4delta30 vaccine
- General good health
- Available for the duration of the study
- Willing to use accepted forms of contraception
Exclusion Criteria:
- Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease by history, physical examination, or laboratory studies including urinalysis
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study
- Certain abnormal laboratory values
- Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months of study entry
- History of severe allergy or anaphylaxis
- Severe asthma requiring an emergency room visit or hospitalization within 6 months of study entry
- HIV infected
- Hepatitis C virus infected
- Hepatitis B surface antibody positive
- Known immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive drugs 30 days prior to study entry. Participants who have used topical or nasal corticosteroids are not excluded.
- Receipt of live vaccine within 4 weeks of study entry
- Receipt of killed vaccine within 2 weeks of study entry
- Absence of spleen
- Plan to travel to an area where dengue virus is common
- Any investigational product within 30 days of study entry
- Other condition that, in the opinion of the investigator, would interfere with the study
- Pregnancy or breastfeeding
Sites / Locations
- Center for Immunization Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
1
2
3
4
5
Participants previously vaccinated with rDEN4delta30 will receive one subcutaneous vaccination (10^3 dose of vaccine) of rDEN1delta30 vaccine into the deltoid region of either arm.
Participants previously vaccinated with rDEN4delta30 will receive one subcutaneous vaccination (10^3 dose of vaccine) of rDEN2/4delta30(ME) into the deltoid region of either arm.
Participants previously vaccinated with rDEN2/4delta30(ME) will receive one subcutaneous vaccination (10^3 dose of vaccine) of rDEN1delta30 vaccine into the deltoid region of either arm.
Participants previously vaccinated with rDEN1delta30 will receive one subcutaneous vaccination (10^3 dose of vaccine) of rDEN2/4delta30(ME) vaccine into the deltoid region of either arm.
One subcutaneous vaccination with placebo into the deltoid region of either arm.