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| Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Center for Immunization Research |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00322946 |
Purpose
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 evaluate the safety and immune response to the dengue vaccine DEN4delta30-4995 in healthy adults.
| Condition | Intervention | Phase |
|
Dengue |
Biological: rDEN4delta30-4995 Biological: Placebo |
Phase I |
| MedlinePlus related topics: | Dengue Fever Hemorrhagic Fevers |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase 1 Study of the Safety and Immunogenicity of rDEN4delta30-4995, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 4 |
| Estimated Enrollment: | 84 |
| Study Start Date: | January 2007 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
One subcutaneous vaccination with rDEN4delta30-4995 vaccine (10^5 PFU dose) into the deltoid region of either arm.
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Biological: rDEN4delta30-4995
Live attenuated rDEN4delta30-4995 vaccine (one of three doses)
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2: Experimental
One subcutaneous vaccination with rDEN4delta30-4995 vaccine (10^3 PFU dose) into the deltoid region of either arm. This arm will enroll after Arm 1.
|
Biological: rDEN4delta30-4995
Live attenuated rDEN4delta30-4995 vaccine (one of three doses)
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3: Experimental
One subcutaneous vaccination with rDEN4delta30-4995 vaccine (10^1 PFU dose) into the deltoid region of either arm. This arm will enroll after Arms 1 and 2.
|
Biological: rDEN4delta30-4995
Live attenuated rDEN4delta30-4995 vaccine (one of three doses)
|
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4: Placebo Comparator
One subcutaneous vaccination with placebo into the deltoid region of either arm.
|
Biological: Placebo
Placebo for rDEN4delta30-4995
|
Dengue viruses account for more than 50 million cases of dengue fever and a half million cases of the more severe disease, dengue hemorrhagic fever/dengue shock syndrome. Infection with dengue viruses is the leading cause of hospitalization and death in children in at least eight Asian countries. The goal of producing a vaccine against dengue fever is to induce a long-lived antibody response against all four dengue serotypes. The rDEN4delta30-4995 vaccine candidate is a live attenuated recombinant virus derived from rDEN4delta30 for protection against dengue virus serotype 4. The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of rDEN4delta30-4995 in healthy adults.
This study will last 180 days (6 months). Participants in Cohort 1 will be randomly assigned to receive the highest dose of rDEN4delta30 or placebo at study entry. Participants in Cohort 2 will be randomly assigned to receive a lower dose of rDEN4delta30 or placebo. Participants in Cohort 3 will be randomly assigned to receive the lowest dose of rDEN4delta30 or placebo. Cohorts 2 and 3 will begin after a safety review of all participants in the previous cohort.
After initial vaccination, participants in Cohort 1 will be followed every other day for the first 16 days of the study, monitoring their temperature three times a day through Day 16 and recording these measurements in a diary. After Day 16, study visits will occur on Days 21, 28, 42, and 180 and will include a physical exam and blood collection. Some participants will also be asked to undergo a skin biopsy or additional blood collection at selected visits.
Eligibility
| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Tennessee | |||||
| Vanderbilt University School of Medicine | Recruiting | ||||
| Nashville, Tennessee, United States, 37232-2581 | |||||
| Contact: Peter Wright, MD 615-343-6260 | |||||
| Principal Investigator: Peter Wright, MD | |||||
| National Institute of Allergy and Infectious Diseases (NIAID) |
| Center for Immunization Research |
| Principal Investigator: | Anna Durbin, MD | Center for Immunization Research (CIR), Johns Hopkins School of Public Health |
More Information
| Responsible Party: | Center for Immunization Research, Johns Hopkins School of Public Health ( Anna Durbin, MD ) |
| Study ID Numbers: | CIR 221, WIRB Protocol Number 20061807 |
| First Received: | May 4, 2006 |
| Last Updated: | January 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00322946 |
| Health Authority: | United States: Food and Drug Administration |
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