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

NCT01676402 Phase 1 COMPLETED

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.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	COMPLETED
Enrolment	316
Start date	2012-08
Completion	2014-04

Conditions

• Influenza

Interventions

• Seasonal Influenza DNA vaccine
• TIV

Primary outcomes

• Incidence of solicited adverse events after the first injection — Day 0 to Day 7
  Incidence is reported for solicited events for 7 days after the first injection. For all Groups the collection period for solicited adverse events following the first injection Day 0 to Day 7.
• Incidence of solicited adverse events after the second injection — Day of injection to 7 days after second injection
  Incidence is reported for solicited events for 7 days after the second injection. The period of solicitation is defined by the actual day of second injection.
• Incidence of unsolicited adverse events of any severity 28 days after the first injection — Day 0 to Day 28
  Incidence is reported for unsolicited events for 28 days after the first injection. For all Groups the reporting period for unsolicited adverse events following the first injection Day 0 to Day 28.
• Incidence of unsolicited adverse events of any severity for 28 days after the second injection — Day of injection to 28 days after injection
  The 28 day period following second injection is defined by the actual day of second injection.
• Incidence of serious adverse events or new chronic medical conditions through 24 weeks after the 2nd injection — Day 0 to 24 weeks after second injection
  The day of second injection varies by group; the duration of time from Day 0 through 24 weeks after second injection is defined by the actual day of second injection.
• Number of subjects with influenza or influenza-like illnesses (ILI) — Day 0 to 24 weeks after second injection
  The day of second injection varies by group; the duration of time from Day 0 through 24 weeks after second injection is defined by the actual day of second injection.

Countries

United States