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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Center for Immunization Research |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00831012 |
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.
Condition | Intervention | Phase |
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Dengue Fever |
Biological: rDEN3delta30/31‐7164 |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 56 |
Arms | Assigned Interventions |
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Group 1: Experimental
Group 1 will consist of healthy participants receiving an immunization of 10^3 PFU rDEN3delta30/31‐7164
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Biological: rDEN3delta30/31‐7164
A live attenuated, recombinant DEN3 candidate vaccine virus
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Group 2: Experimental
Group 2A will consist of healthy participants who will receive an immunization of 10^5 PFU of rDEN3delta30/31‐7164 vaccine or placebo. Group 2A participants will be enrolled if less that 90% of Group 1 participants seroconvert to DEN3 by Study Day 42. Group 2B will consist of healthy participants who will receive an immunization of 10^1 PFU of rDEN3delta30/31‐7164 vaccine or placebo. Group 2B participants will be enrolled if more that 90% of Group 1 participants seroconvert to DEN3 by Study Day 42. |
Biological: rDEN3delta30/31‐7164
A live attenuated, recombinant DEN3 candidate vaccine virus
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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 rDEN3delta30/31‐7164.
This study will consist of two groups, with Group 1 enrolling first. Group 1 participants will be randomly assigned to receive either 10^3 PFU of rDEN3delta30/31-7164 or placebo subcutaneously in their deltoid.
Participants will be monitored at the clinic for 30 minutes after receiving the immunization to monitor for adverse effects. After that, participants will be asked to return to the clinic approximately every other day for the next 16 days, and then on Day 21, 28, 42, and 180. At each visit participants will have physical and clinical exams, vital signs, measures, blood drawn, and will be asked about any adverse events they may have experience. Female participants will be given a pregnancy test. In addition, participants will be asked to measure their temperature 3 times a day and record it in a temperature diary for the first 16 days after immunization.
If less than 90% of the participants in Group 1 seroconvert to DEN3 then Group 2A will be enrolled. Group 2A will follow the same procedures as Group 1, but will receive a 10^5 PFU dose of rDEN3delta30/31-7164.
If more than 90% of the participants in Group 1 seroconvert to DEN3 then Group 2B will be enrolled. Group 2A will follow the same procedures as Group 1, but will receive a 10^1 PFU dose of rDEN3delta30/31-7164.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Daniel Elwood | 410-614-1880 | delwood@jhsph.edu |
United States, Maryland | |
Center for Immune Research | |
Baltimore, Maryland, United States |
Study Chair: | Anna Durbin, MD | Center for Immunization Research (CIR), Johns Hopkins School of Public Health |
Responsible Party: | Center for Immunization Research, Johns Hopkins School of Public Health ( Anna Durbin ) |
Study ID Numbers: | CIR 257 |
Study First Received: | January 27, 2009 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00831012 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dengue Vaccine Dengue Virus Dengue Hemorrhagic Fever Dengue Shock Syndrome |
Virus Diseases Fever Hemorrhagic Fevers, Viral Shock Dengue Dengue Fever |
Viral Hemorrhagic Fever Healthy Hemorrhagic Fever Arbovirus Infections Dengue Hemorrhagic Fever |
Virus Diseases Hemorrhagic Fevers, Viral RNA Virus Infections Flaviviridae Infections |
Flavivirus Infections Dengue Arbovirus Infections Dengue Hemorrhagic Fever |