Clinical Trial: Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase 2a Randomized, Double-Blind, Dose-Optimizing Study to Evaluate the Immunogenicity of Hantaan/Puumala Virus DNA Vaccine Administered to Healthy Adult Volunteers Using the TDS-IM Electroporation

Brief Summary: The purpose of this study is to compare the immune responses of two different doses (1.0 mg and 2.0 mg) and two different dosing schedules (two doses or three doses) of a mixed Hantaan virus (HTNV) and Puumala virus (PUUV) DNA vaccine in healthy participants. To maintain a blind, participants in the two-dose group will receive one dose of normal saline placebo. All of the groups will also receive a booster dose 6 months after first vaccination. The results will help to determine which dose and vaccination schedule will be best to move forward in the vaccine development process.

Detailed Summary:
Sponsor: U.S. Army Medical Research and Materiel Command

Current Primary Outcome: Seroconversion rates of the HTNV/PUUV DNA vaccine [ Time Frame: Study Days 0 to 365 ]

The primary endpoint will be to determine the seroconversion rates of the vaccines. Seroconversion is defined as production of neutralizing antibody titers measured using a pseudovirion neutralization assay (PsVNA). A PsVNA50 titer ≥ 20 is considered positive.


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of adverse events (AEs) in study subjects [ Time Frame: 2 years ]

Original Secondary Outcome: Rate of adverse events (AEs) in study subjects [ Time Frame: Study Days 0 to 14, 28 to 42, 56 to 70 and 168 to 182 ]

Solicited AEs occurring from the time of each injection through 14 days following the procedure, with the first 7 days following vaccination to be assisted with a memory aid.


Information By: U.S. Army Medical Research and Materiel Command

Dates:
Date Received: April 14, 2014
Date Started: May 2014
Date Completion: December 2017
Last Updated: March 28, 2017
Last Verified: March 2017