Safety and Immune Response to Two Doses of rDEN2/4delta30 Dengue Vaccine
Safety and Immunogenicity of a 2-Dose Regimen of rDEN2/4Δ30 Dengue Vaccine With Boosting at 4 Versus 6 Months
1 other identifier
interventional
25
1 country
1
Brief Summary
Dengue fever, caused by dengue viruses, is a major health problem in the 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 Jan 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 11, 2009
CompletedFirst Posted
Study publicly available on registry
June 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJanuary 3, 2013
December 1, 2012
1 year
June 11, 2009
December 31, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Determine the frequency of vaccine related AEs for each dose, graded by severity.
Throughout study
Compare the immunogenicity of the two 2-dose regimens of the rDEN2/4Δ30(ME) candidate vaccine as assessed by neutralizing antibody titers to DEN2
At 4 and 6 weeks after each vaccination
Secondary Outcomes (4)
Assess the frequency, quantity, and duration of viremia after each dose of vaccine.
Throughout study
Determine the number of vaccinees infected with rDEN2/4Δ30(ME)
Throughout study
Comparison of infectivity rates, safety, and immunogenicity between dose 1 and dose 2 withhin cohort and between cohorts
Throughout study
Evaluation of the phenotype and activation of peripheral blood mononuclear cells at primary infection and upon reinfection with the DEN2/4Δ30(ME) vaccine.
Throughout study
Study Arms (2)
1
ACTIVE COMPARATORParticipants will receive 1 injection of rDEN2/4delta30(ME) or placebo vaccine on Days 0 and 180
2
ACTIVE COMPARATORParticipants will receive 1 injection of rDEN2/4delta30(ME) or placebo vaccine on Days 0 and 120
Interventions
Eligibility Criteria
You may qualify if:
- Good general health as determined by means of the screening procedures.
- Available for the duration of the study (32 weeks for cohort 1 and 23 weeks for cohort 2)
- Willing to use effective methods of contraception
You may not qualify if:
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator will affect the ability of the volunteer to understand and cooperate with the requirements of the study protocol
- Neutropenia as defined by an ANC ≤1500/mm3
- ALT level above the laboratory-defined upper limit of normal
- Serum creatinine level above the laboratory-defined upper limit of normal
- Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
- History of a severe allergic reaction or anaphylaxis
- Severe asthma (emergency room visit or hospitalization within the last 6 months)
- Positive HIV-1 serology by screening and confirmatory assays
- Positive for hepatitis C virus (HCV) by screening and confirmatory assays
- Positive hepatitis B surface antigen (HBsAg) by enzyme-linked immunosorbent assay (ELISA)
- Known immunodeficiency syndrome
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study
- Receipt of a live vaccine within the 4 weeks or a killed vaccine within the 2 weeks prior to entry into the study
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Immunization Research
Baltimore, Maryland, 21205, United States
Related Publications (1)
Katzelnick LC, Fonville JM, Gromowski GD, Bustos Arriaga J, Green A, James SL, Lau L, Montoya M, Wang C, VanBlargan LA, Russell CA, Thu HM, Pierson TC, Buchy P, Aaskov JG, Munoz-Jordan JL, Vasilakis N, Gibbons RV, Tesh RB, Osterhaus AD, Fouchier RA, Durbin A, Simmons CP, Holmes EC, Harris E, Whitehead SS, Smith DJ. Dengue viruses cluster antigenically but not as discrete serotypes. Science. 2015 Sep 18;349(6254):1338-43. doi: 10.1126/science.aac5017.
PMID: 26383952DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Durbin, MD
Johns Hopkins Bloomberg School of Public Health
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2009
First Posted
June 15, 2009
Study Start
January 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
January 3, 2013
Record last verified: 2012-12