Evaluation of the Safety and Immune Response to an Investigational Dengue Type 1 Vaccine
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|ClinicalTrials.gov Identifier: NCT01084291|
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : January 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|Dengue Virus||Biological: Investigational Vaccine for DEN1 Other: Placebo injection||Phase 1|
The dengue virus causes approximately 50 million cases of dengue fever and 1.5 million cases of the more severe diseases dengue hemorrhagic fever (DHS) and dengue shock syndrome (DSS) every year. There are four subtypes of the virus, and infection with one offers no protection from infection by the others. In fact, most cases of DHS and DSS occur in people infected by more than one subtype. In areas of the world where multiple subtypes of dengue are common, vaccines must be developed against each of the subtypes of dengue virus. This study will examine the safety and immune response of an investigational vaccine for preventing infection with DEN1.
Participation in this study will last about 6 weeks. Participants will be randomly assigned to be injected with either the investigational study vaccine or a placebo. Participants will have a five in six chance of receiving the vaccine. The first study visit will take place on the vaccination day, on which participants will undergo a physical examination, blood draw, and pregnancy test, and then receive the vaccine. Participants will be given a thermometer and temperature card, and be told to record their temperature three times per day for 16 days after vaccination. Participants will come to follow-up visits every other day for the 16 days after vaccination, and then 3, 4, and 6 weeks after vaccination (Days 21, 28, and 42). Assessments completed during these visits will include a questionnaire about how the participant is feeling, pregnancy test, review of temperature cards, blood draw, and physical exam. Blood drawn will be analyzed to check participants' health, determine the amount of vaccine and antibodies in the blood, test markers in white blood cells and genes, and look for proteins that are important for fighting dengue infection.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase I Evaluation of the Safety and Immunogenicity of the rDEN1∆30 Dengue Serotype 1 Vaccine Given at a Single Dose of 101 PFU in Healthy Flavivirus-naïve Adult Subjects|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||June 2010|
Experimental: DEN1 Vaccine
Participants will receive a single dose of investigational vaccine for dengue virus subtype 1.
Biological: Investigational Vaccine for DEN1
Subcutaneous injection in upper arm of vaccine at dose of 10 plaque-forming units (PFU)
Other Name: rDEN1∆30 vaccine
Placebo Comparator: Placebo
Participants will receive a single dose of placebo vaccine.
Other: Placebo injection
Subcutaneous injection of placebo
- Frequency of vaccine-related adverse events (AEs), as classified by both severity and seriousness, through active and passive surveillance [ Time Frame: Measured throughout study ]
- Immunogenicity to dengue virus subtype one (DEN1), as assessed by neutralizing antibody titers [ Time Frame: Measured 4 and 6 weeks after vaccination ]
- Frequency, quantity, and duration of viremia following vaccination [ Time Frame: Measured every other day after vaccination for 16 days, and on Days 21, 28, and 42 ]
- Number of vaccinees infected with DEN1, defined as recovery of vaccine virus from the blood or serum of a participant and/or by seroconversion to DEN1 [ Time Frame: Measured at study completion ]
- Comparison of the infectivity rates, safety, and immunogenicity of a single dose of DEN1 vaccine to those rates of previous clinical trials [ Time Frame: Measured at study completion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084291
|United States, Vermont|
|Fletcher Allen Health Care (FAHC) General Clinical Research Center (GCRC)|
|Burlington, Vermont, United States, 05401|
|University of Vermont Vaccine Testing Center|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||Anna Durbin, MD||CIR, Johns Hopkins University|
|Principal Investigator:||Beth Kirkpatrick, MD||University of Vermont|