Open-Label, Randomized Phase 1b Study of the Safety & Immunogenicity of Investigational Seasonal Influenza DNA Vaccine Followed by TIV Administered Intradermally (ID) or Intramuscularly (IM) in Healthy Adults 18-70 Years
This is a Phase Ib study in healthy adults (18-70 years) to evaluate the safety, tolerability, and immunogenicity of same season and sequential season vaccination schedules consisting of the 2012/2013 seasonal influenza DNA vaccine (HA DNA) and licensed trivalent influenza vaccine (TIV) administered intradermally (ID) or intramuscularly (IM). The hypothesis is that evaluation of these investigational schedules will inform development of novel influenza vaccine strategies that may offer improved and cross-protective immunity against antigenically diverse influenza strains.
- biological : TIV
- biological : Seasonal Influenza DNA vaccine
Phase: Phase 1
Ages Eligible For Study:
A subject must meet all of the following criteria: - Healthy adults, 18 to 70 years old; volunteers who will be older than 64 during the 2013/2014 influenza season will not be enrolled after 11/16/2012. - Available for clinical follow-up - Able and willing to complete the informed consent process - Willing to donate blood for sample storage to be used for future research - Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) ?40 within the 70 days prior to enrollment - Has not yet received the current year (2012/13) influenza vaccine prior to enrollment and agrees to receive seasonal influenza vaccines during study participation only from the study site Laboratory Criteria within 70 days prior to enrollment: - Hemoglobin within institutional normal limits - White blood cells either within institutional normal range or accompanied by site physician approval as consistent with healthy adult status - Platelets = 125,000 - 500,000/mm3 - Alanine aminotransferase (ALT) ? 2.5 x upper limit of normal (ULN) - Serum creatinine ? 1 x ULN based on site institutional normal range Criteria applicable to women of childbearing potential: - Negative human chorionic gonadotropin (?-HCG) pregnancy test (urine or serum) on day of enrollment - Agree to use an effective means of birth control from 21 days prior to enrollment through 3 weeks after the second study vaccination