Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3/4delta30[ME]) in Healthy Adults
NCT ID: NCT00375726
Last Updated: 2010-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
58 participants
INTERVENTIONAL
2006-10-31
2008-09-30
Brief Summary
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Detailed Description
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This study will last 40 weeks. Participants will be randomly assigned to receive one of three doses of rDEN3/4delta30(ME) or placebo. Participants in Group 1 will receive the middle dose of rDEN3/4delta30(ME) or placebo at study entry. Group 2a will begin enrollment after the immunogenicity review of all participants in Group 1. Participants in Group 2a will receive the highest dose of rDEN4delta30(ME) or placebo at study entry. Group 2b will begin enrollment after the immunogenicity review of all participants in Group 2a. Participants in Group 2b will receive the lowest dose of rDEN4delta30(ME) or placebo.
After vaccination, participants in all groups will be followed closely every other day for the first 16 days of the study. Participants will take their temperature three times a day through Day 16 and record each measurement in a diary. After Day 16, participants will have study visits on Days 21, 28, 42, and 180; a physical exam and blood collection will occur at all visits. Some participants may be asked to join a skin biopsy substudy.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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1
One subcutaneous vaccination with rDEN3/4delta30(ME) vaccine (10\^3 PFU dose) into the deltoid region of either arm.
rDEN3/4delta30(ME)
Live attenuated rDEN3/4delta30(ME) vaccine (one of three doses)
2
One subcutaneous vaccination with rDEN3/4delta30(ME) vaccine (10\^5 PFU dose) into the deltoid region of either arm. This arm may enroll after Arm 1 depending on the immunological response of Arm 1.
rDEN3/4delta30(ME)
Live attenuated rDEN3/4delta30(ME) vaccine (one of three doses)
3
One subcutaneous vaccination with rDEN3/4delta30(ME) vaccine (10\^1 PFU dose) into the deltoid region of either arm. This arm may enroll after Arm 1 depending on the immunological response of Arm 1.
rDEN3/4delta30(ME)
Live attenuated rDEN3/4delta30(ME) vaccine (one of three doses)
4
One subcutaneous vaccination with placebo into the deltoid region of either arm.
Placebo
Placebo for rDEN3/4delta30(ME)
Interventions
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rDEN3/4delta30(ME)
Live attenuated rDEN3/4delta30(ME) vaccine (one of three doses)
Placebo
Placebo for rDEN3/4delta30(ME)
Eligibility Criteria
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Inclusion Criteria
* Available for the duration of the study
* Willing to use acceptable forms of contraception for the duration of the study
Exclusion Criteria
* Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study
* Significant laboratory abnormalities
* Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months prior to study entry
* History of severe allergic reaction or anaphylaxis
* Emergency room visit or hospitalization for severe asthma within 6 months prior to study entry
* HIV-1 infected
* Hepatitis C virus (HCV) infected
* Hepatitis B surface antigen positive
* Immunodeficiency syndrome
* Use of corticosteroids or immunosuppressive medications within 30 days prior to study entry. Participants using topical or nasal corticosteroids are not excluded.
* Live vaccine within 4 weeks prior to study entry
* Killed vaccine within 2 weeks prior to study entry
* Absence of spleen
* Blood products within 6 months prior to study entry
* Previous dengue virus or other flavivirus (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus) infection
* Previously received yellow fever or dengue vaccine
* Plans to travel to an area where dengue infection is common
* Received an investigational agent within 30 days prior to study entry
* Other condition that, in the opinion of the investigator, would interfere with the study
* Pregnancy or breastfeeding
18 Years
50 Years
ALL
Yes
Sponsors
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Johns Hopkins Bloomberg School of Public Health
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Center for Immunization Research, Johns Hopkins School of Public Health
Principal Investigators
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Anna Durbin, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Immunization Research, Johns Hopkins School of Public Health
Locations
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Center for Immunization Research
Baltimore, Maryland, United States
Countries
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References
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Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS. Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol. 2006 Spring;19(1):10-32. doi: 10.1089/vim.2006.19.10.
Blaney JE Jr, Hanson CT, Firestone CY, Hanley KA, Murphy BR, Whitehead SS. Genetically modified, live attenuated dengue virus type 3 vaccine candidates. Am J Trop Med Hyg. 2004 Dec;71(6):811-21.
Blaney JE Jr, Matro JM, Murphy BR, Whitehead SS. Recombinant, live-attenuated tetravalent dengue virus vaccine formulations induce a balanced, broad, and protective neutralizing antibody response against each of the four serotypes in rhesus monkeys. J Virol. 2005 May;79(9):5516-28. doi: 10.1128/JVI.79.9.5516-5528.2005.
Durbin AP, Whitehead SS, McArthur J, Perreault JR, Blaney JE Jr, Thumar B, Murphy BR, Karron RA. rDEN4delta30, a live attenuated dengue virus type 4 vaccine candidate, is safe, immunogenic, and highly infectious in healthy adult volunteers. J Infect Dis. 2005 Mar 1;191(5):710-8. doi: 10.1086/427780. Epub 2005 Jan 27.
Other Identifiers
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WIRB Protocol Number 20061667
Identifier Type: -
Identifier Source: secondary_id
CIR 228
Identifier Type: -
Identifier Source: org_study_id