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
  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 April 20, 2014