Overview

This trial is active, not recruiting.

Condition healthy
Treatment denvax
Phase phase 1
Sponsor Inviragen Inc.
Start date February 2012
End date March 2014
Trial size 136 participants
Trial identifier NCT01542632, INV-DEN-104

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
denvax
DENVax given subcutaneously at Day 0 and 90
(Experimental)
denvax
DENVax given subcutaneously at Day 0 and 90
(Experimental)
denvax
DENVax given subcutaneously at Day 0 and 90
(Experimental)
DENVax new formulation
denvax
DENVax given subcutaneously at Day 0 and 90
(Experimental)
DENVax current formulation
denvax
DENVax given subcutaneously at Day 0 and 90
(Experimental)
DENVax current formulation
denvax
DENVax given subcutaneously at Day 0 and 90

Primary Outcomes

Measure
Frequency and severity of adverse events, including local and systemic reactions
time frame: various timepoints up to 30 days after each dose

Secondary Outcomes

Measure
Immunogenicity
time frame: various timepoints up to 30 days after each dose

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Inviragen Inc..