Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults
Phase I Study of the Safety and Immunogenicity of rDEN1delta30, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 1
2 other identifiers
interventional
28
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 test the safety of and immune response to a new dengue virus vaccine in healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2004
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
August 17, 2004
CompletedFirst Posted
Study publicly available on registry
August 19, 2004
CompletedStudy Start
First participant enrolled
September 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedJanuary 18, 2008
January 1, 2008
1.2 years
August 17, 2004
January 17, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Determine the frequency of vaccine related AEs for each dose graded by severity
Throughout study
Determine the amount of dengue 1 neutralizing antibody induced by the vaccine
At Day 42
Secondary Outcomes (5)
To assess the durability of the antibody response
At Day 180
To assess the frequency, quantity, and duration of viremia in each dose cohort studied
Throughout study
To compare the T cell mediated immune response against dengue viruses of those volunteers infected with the rDEN1delta30 vaccine virus with that of uninfected volunteers and placebo recipients
Throughout study
If both doses of vaccine are administered, to compare the infectivity rates, safety, and immunogenicity between dose groups
At study completion
To evaluate the immunopathological mechanism of vaccine-associated rash in those volunteers who are willing to undergo skin biopsy
Throughout study
Study Arms (3)
1
EXPERIMENTALOne subcutaneous vaccination with rDEN1delta30 vaccine (10\^3 PFU dose) into the deltoid region of either arm.
2
EXPERIMENTALOne subcutaneous vaccination with rDEN1delta30 vaccine (10\^5 PFU dose) into the deltoid region of either arm. This arm may enroll after Arm 1 depending on the effect of the vaccine on subjects in Arm 1.
3
PLACEBO COMPARATOROne subcutaneous vaccination with placebo into the deltoid region of either arm.
Interventions
Eligibility Criteria
You may qualify if:
- Willing to be followed for the duration of the study
- Willing to use acceptable methods of contraception
- Good general health
You may not qualify if:
- Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
- Liver, renal, or hematologic disease
- Alcohol or drug abuse within 12 months of study entry
- History of severe allergic reaction or anaphylaxis
- Emergency room visit or hospitalization for severe asthma within 6 months of study entry
- HIV-1 infected
- HCV infected
- Hepatitis B surface antigen positive
- Known immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical or nasal corticosteroids are not excluded.
- Live vaccine within 4 weeks of study entry
- Killed vaccine within 2 weeks of study entry
- Blood products within 6 months of study entry
- Investigational drugs or vaccines within 60 days prior to study entry or while currently enrolled in this clinical trial
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Immunization Research, Johns Hopkins School of Public Health
Baltimore, Maryland, 21205, United States
Related Publications (4)
Jacobs M, Young P. Dengue vaccines: preparing to roll back dengue. Curr Opin Investig Drugs. 2003 Feb;4(2):168-71.
PMID: 12669377BACKGROUNDPang T. Vaccines for the prevention of neglected diseases--dengue fever. Curr Opin Biotechnol. 2003 Jun;14(3):332-6. doi: 10.1016/s0958-1669(03)00061-2.
PMID: 12849789BACKGROUNDRothman AL. Dengue: defining protective versus pathologic immunity. J Clin Invest. 2004 Apr;113(7):946-51. doi: 10.1172/JCI21512.
PMID: 15057297BACKGROUNDSun W, Edelman R, Kanesa-Thasan N, Eckels KH, Putnak JR, King AD, Houng HS, Tang D, Scherer JM, Hoke CH Jr, Innis BL. Vaccination of human volunteers with monovalent and tetravalent live-attenuated dengue vaccine candidates. Am J Trop Med Hyg. 2003 Dec;69(6 Suppl):24-31. doi: 10.4269/ajtmh.2003.69.6_suppl.0690024.
PMID: 14740952BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Durbin, MD
Center for Immunization Research, John 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
August 17, 2004
First Posted
August 19, 2004
Study Start
September 1, 2004
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
January 18, 2008
Record last verified: 2008-01