Open-Label, Dose-Escalation, Phase I Study of the Prime-Boost Investigational 2012/13 Seasonal Influenza DNA Vaccine, VRC-FLUDNA063-00-VP, Followed by the 2012/2013 Seasonal TIV Compared to TIV Prime-Boost in Children/Adolescents Ages 6-17

NCT01609998 Phase 1 COMPLETED

This is a Phase I, dose escalation study in healthy adolescents and children (6-17 years) to evaluate the safety, tolerability, and immunogenicity of a prime-boost regimen of the 2012/2013 seasonal influenza DNA vaccine (HA DNA) followed by licensed 2012/2013 TIV vaccine. The comparator groups will receive licensed 2012/2013 TIV as prime and boost. The hypothesis is that the 2012/2013 HA DNA prime-TIV boost regimen will be safe and result in a broader and more durable immune response than is observed in age-matched comparator TIV-TIV groups.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	COMPLETED
Enrolment	75
Start date	2012-06
Completion	2013-07

Conditions

• Influenza

Interventions

• Seasonal Influenza DNA vaccine
• TIV

Primary outcomes

• Incidence of solicited and unsolicited adverse events — 7 days after injection for solicited events; from 1st injection to study completion for unsolicited events
  Incidence is reported for solicited events for 7 days after each injection, for unsolicited adverse event (AE) of any severity for 28 days after each injection, and for serious adverse events or new chronic medical conditions through 24 weeks after the 2nd injection.
• Mean change from baseline in safety laboratory measures — Day 28
  At day 28 (+/- 7 days) blood will be drawn prior to receiving the second injection to measure hemoglobin, creatinine, and alanine transaminase (ALT).
• Number of subjects with influenza or influenza-like illnesses — Day 0 through 24 weeks post TIV boost (Day 294)
  Participants who experience at least one influenza or influenza-like illness will be counted.

Countries

United States