Safety and Immune Response to Two Doses of rDEN2/4delta30 Dengue Vaccine
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00920517
First received: June 11, 2009
Last updated: December 31, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dengue Fever |
Biological: rDEN2/4delta30(ME) vaccine Biological: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention |
| Official Title: | Safety and Immunogenicity of a 2-Dose Regimen of rDEN2/4Δ30 Dengue Vaccine With Boosting at 4 Versus 6 Months |
Resource links provided by NLM:
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcome Measures:
- Determine the frequency of vaccine related AEs for each dose, graded by severity. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Compare the immunogenicity of the two 2-dose regimens of the rDEN2/4Δ30(ME) candidate vaccine as assessed by neutralizing antibody titers to DEN2 [ Time Frame: At 4 and 6 weeks after each vaccination ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assess the frequency, quantity, and duration of viremia after each dose of vaccine. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Determine the number of vaccinees infected with rDEN2/4Δ30(ME) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Comparison of infectivity rates, safety, and immunogenicity between dose 1 and dose 2 withhin cohort and between cohorts [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Evaluation of the phenotype and activation of peripheral blood mononuclear cells at primary infection and upon reinfection with the DEN2/4Δ30(ME) vaccine. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | January 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Participants will receive 1 injection of rDEN2/4delta30(ME) or placebo vaccine on Days 0 and 180
|
Biological: rDEN2/4delta30(ME) vaccine
10^3 PFU dose
Biological: Placebo
placebo for rDEN2/4delta30(ME) vaccine
|
|
Active Comparator: 2
Participants will receive 1 injection of rDEN2/4delta30(ME) or placebo vaccine on Days 0 and 120
|
Biological: rDEN2/4delta30(ME) vaccine
10^3 PFU dose
Biological: Placebo
placebo for rDEN2/4delta30(ME) vaccine
|
Detailed Description:
Dengue viruses, which cause dengue fever and dengue shock syndrome, are a major cause of morbidity and mortality in several of the world's tropical and subtropical regions. The rDEN2/4delta30(ME) vaccine is a live attenuated dengue virus vaccine that may be protective against dengue virus serotype 2 (DEN2). The purpose of this study is to evaluate the safety and immunogenicity of the rDEN2/4delta30(ME) vaccine in healthy adults.
This study will last approximately 5 to 7 months with 25 study visits. Participants will be randomly assigned into one of two cohorts. Participants in Cohort 1 will receive an injection of rDEN2/4delta30(ME) or placebo vaccine at Days 0 and 180. Participants in Cohort 2 will receive an injection of rDEN2/4delta30(ME) or placebo vaccine at Days 0 and 120. Participants will be asked to record their temperature in a diary for 16 days after each vaccination. At each study visit a physical examination, symptom history, and blood and urine collection will occur.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Has had spleen surgically removed
- Receipt of blood products within the 6 months prior to study entry
- History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g. yellow fever virus, St. Louis encephalitis, West Nile virus).
- Previous receipt of yellow fever or dengue vaccine (licensed or experimental)
- Persons who have received any investigational agent in the 30 days prior to study entry
- Persons who have definite plans to travel to a dengue endemic area during the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920517
Locations
| United States, Maryland | |
| Center for Immunization Research | |
| Baltimore, Maryland, United States, 21205 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Anna Durbin, MD | Johns Hopkins School of Public Health |
More Information
No publications provided
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00920517 History of Changes |
| Other Study ID Numbers: | CIR 250 |
| Study First Received: | June 11, 2009 |
| Last Updated: | December 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Dengue Dengue Hemorrhagic Fever Arbovirus Infections Virus Diseases |
Flavivirus Infections Flaviviridae Infections RNA Virus Infections Hemorrhagic Fevers, Viral |
ClinicalTrials.gov processed this record on June 18, 2013