Safety of and Immune Response to a Dengue Virus Vaccine (rDEN4delta30-4995) in Healthy Adults
Phase 1 Study of the Safety and Immunogenicity of rDEN4delta30-4995, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 4
2 other identifiers
interventional
84
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2006
CompletedFirst Posted
Study publicly available on registry
May 8, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedAugust 7, 2009
November 1, 2008
2.6 years
May 4, 2006
August 5, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Frequency of vaccine-related adverse events, graded by severity for each dose
Throughout study
Immunogenicity of the rDEN4delta30-4995 vaccine against DEN4 virus by measurement of plaque reduction neutralization titers (PRNT)
At Days 28 and 42
Secondary Outcomes (3)
Durability of antibody responses to DEN4 virus
At Month 6
Frequency, quantity, and duration of viremia in each dose cohort studied based on the mean peak viremia, mean day onset of viremia, and mean duration of viremia of each dose cohort
Throughout study
Number of vaccinees infected with the rDEN4delta30-4995 chimeric vaccine
Throughout study
Study Arms (4)
1
EXPERIMENTALOne subcutaneous vaccination with rDEN4delta30-4995 vaccine (10\^5 PFU dose) into the deltoid region of either arm.
2
EXPERIMENTALOne subcutaneous vaccination with rDEN4delta30-4995 vaccine (10\^3 PFU dose) into the deltoid region of either arm. This arm will enroll after Arm 1.
3
EXPERIMENTALOne 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.
4
PLACEBO COMPARATOROne subcutaneous vaccination with placebo into the deltoid region of either arm.
Interventions
Eligibility Criteria
You may qualify if:
- Adult males and non-pregnant females between 18 and 50 years of age
- Good general health
- Available for the duration of the study
- Willing to use acceptable methods of contraception for the duration of the study
You may not qualify if:
- Significant neurologic, cardiac, lung, liver, rheumatologic, autoimmune, or kidney disease
- 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
- Severe asthma
- HIV-1 serotype infected
- Hepatitis C virus (HCV) infected
- Hepatitis B surface antigen positive
- Immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive medications within 2 weeks prior to study entry. Individuals 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University School of Medicine
Nashville, Tennessee, 37232-2581, United States
Related Publications (4)
Bhamarapravati N, Sutee Y. Live attenuated tetravalent dengue vaccine. Vaccine. 2000 May 26;18 Suppl 2:44-7. doi: 10.1016/s0264-410x(00)00040-2.
PMID: 10821973BACKGROUNDBlaney 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.
PMID: 16553547BACKGROUNDDurbin 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.
PMID: 15688284BACKGROUNDDurbin AP, Karron RA, Sun W, Vaughn DW, Reynolds MJ, Perreault JR, Thumar B, Men R, Lai CJ, Elkins WR, Chanock RM, Murphy BR, Whitehead SS. Attenuation and immunogenicity in humans of a live dengue virus type-4 vaccine candidate with a 30 nucleotide deletion in its 3'-untranslated region. Am J Trop Med Hyg. 2001 Nov;65(5):405-13. doi: 10.4269/ajtmh.2001.65.405.
PMID: 11716091BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Durbin, MD
Center for Immunization Research (CIR), Johns Hopkins School of Public Health
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
May 4, 2006
First Posted
May 8, 2006
Study Start
January 1, 2007
Primary Completion
August 1, 2009
Last Updated
August 7, 2009
Record last verified: 2008-11