a comparison of the safety and immunogenicity of various schedules of dengue vaccine in healthy adult volunteers

Conditions: Healthy

Summary: a phase 1 study to compare the safety, tolerability and immunogenicity of different dose schedules of subcutaneously (sc) administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules of the vaccine. blood samples were obtained for safety labs on days 0, 7, 14, 90, 97, 104 and measurement of viremia at baseline \[during the screening period or on day of vaccination (day 0)\], and then on days 7, 9, 11, 14, 17, 21, 90, 97, and 104. blood samples for measurement of dengue neutralizing antibodies in serum were obtained at baseline \[during the screening period or on day of vaccination (day 0)\], then on days 30, 90 and 120. the entire duration for each individual subjects participation was approximately 5 months including recruitment and collection of data for primary outcomes (through day 120).


Eligibility 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 \[sodium (na), potassium (k), glucose, blood urea nitrogen (bun), creatinine, alanine aminotransferase (alt), aspartate aminotransferase (ast), total bilirubin, white blood cell (wbc), neutrophil count, hemoglobin, platelets, prothrombin time (pt), partial thromboplastin time (ptt), and urinalysis (by dipstick)\]. 4. weight: body mass index (bmi) ≤32 5. blood tests negative for antibodies to human immuno-virus (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

Keywords: safety and immunogenicity of dengue vaccine