A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Inviragen Inc.
ClinicalTrials.gov Identifier:
NCT01542632
First received: February 27, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

An early phase study to compare the safety and tolerability of different dose schedules of SC administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules of the vaccine

Blood samples will be obtained for safety labs on Days 0, 7, 14, 90, 97 and 104 and measurement of viremia at baseline (during the screening period or on Day 0), and then on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue neutralizing antibodies in serum will be obtained at baseline (during the screening period or on Day 0), then on Days 30, 90 and 120.

The entire duration for each individual subject's participation will be approximately 5 months including recruitment and collection of data for primary outcomes (through Day 120).


Condition Intervention Phase
Healthy
Biological: DENVax
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Phase 1b Study to Investigate the Safety and Immunogenicity of Various Schedules of Tetravalent Chimeric Dengue Vaccine in Healthy Adult Volunteers Between the Ages of 18 - 45 Years

Resource links provided by NLM:


Further study details as provided by Inviragen Inc.:

Primary Outcome Measures:
  • Frequency and severity of adverse events, including local and systemic reactions [ Time Frame: various timepoints up to 30 days after each dose ] [ Designated as safety issue: Yes ]
    outcome measures include evaluations of local and systemic reactogenicity and adverse events (all subjects) and measurement of routine hematology and chemistry parameters


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: various timepoints up to 30 days after each dose ] [ Designated as safety issue: Yes ]
    Immunogenicity will be assessed using Neutralizing antibody titers against each of the four dengue serotypes


Estimated Enrollment: 136
Study Start Date: February 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Biological: DENVax
DENVax given subcutaneously at Day 0 and 90
Experimental: Group 2 Biological: DENVax
DENVax given subcutaneously at Day 0 and 90
Experimental: Group 3 Biological: DENVax
DENVax given subcutaneously at Day 0 and 90
Experimental: group 4
DENVax new formulation
Biological: DENVax
DENVax given subcutaneously at Day 0 and 90
Experimental: Group 5
DENVax current formulation
Biological: DENVax
DENVax given subcutaneously at Day 0 and 90
Experimental: Group 6
DENVax current formulation
Biological: DENVax
DENVax given subcutaneously at Day 0 and 90

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female at least 18 years and ≤ 45 years old at time of screening
  2. In good health as determined by medical history, physical examination including height and weight
  3. Normal clinical safety laboratory examinations (Na, K, Glucose, BUN, creatinine, ALT, AST, total bilirubin, WBC, neutrophil count, hemoglobin, platelets, PT, PTT, and urinalysis (by dipstick)).
  4. Weight: Body Mass Index (BMI) ≤32
  5. Blood tests negative for antibodies to HIV-1, Hepatitis C, and Hepatitis B surface antigen

Exclusion Criteria:

  1. Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator
  2. Clinically significant ECG findings
  3. History of any significant dermatologic disease in the last 6 months,
  4. History of diabetes mellitus
  5. History of recurring headaches or migraines (more frequent than once per week) or on prescription medication for treatment of recurring headaches or migraines
  6. Hypersensitivity to any vaccine
  7. Receipt of any vaccine in the 4 weeks preceding the first vaccination
  8. Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in this study
  9. Known history of Japanese Encephalitis Virus (JEV) and/or Yellow Fever (YF)
  10. Previous vaccination (in a clinical trial or with an approved product) against flaviviruses including dengue, yellow fever (YF) and Japanese Encephalitis (JE)
  11. Seropositivity to dengue or West Nile (WN) virus
  12. Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months
  13. Use within the previous 6 months of systemic corticosteroids therapy (at a dose of at least 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or within the last 3 months. Note, inhaled prednisone (or equivalent) is allowed
  14. Use of any non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen or antihistamines for the 3 days immediately prior to each vaccination
  15. Use of any prescription or over the counter medications (besides those specifically mentioned above or those required for medical management of concurrent diseases) 7 days before the first vaccination (Day 0)
  16. Positive urine screen for cocaine, amphetamines, opiates, or cannabinoids
  17. Donation of blood 6 weeks before the first dose(s) (Day 0) until 30 days after the dose on day 90
  18. Females who are pregnant or lactating
  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: NCT01542632

Locations
United States, Colorado
Poudre Valley Health System
Fort Collins, Colorado, United States
United States, Texas
Univ of Texas Medical Branch
Galveston, Texas, United States
United States, Utah
Advanced Clinical Research
Salt Lake City, Utah, United States, 84088
Sponsors and Collaborators
Inviragen Inc.
Investigators
Study Director: Gilad Gordon, MD Inviragen Inc.
  More Information

No publications provided

Responsible Party: Inviragen Inc.
ClinicalTrials.gov Identifier: NCT01542632     History of Changes
Other Study ID Numbers: INV-DEN-104
Study First Received: February 27, 2012
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Inviragen Inc.:
safety and immunogenicity of dengue vaccine

ClinicalTrials.gov processed this record on October 23, 2014