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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014