Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE®

PHASE2CompletedINTERVENTIONAL
Enrollment

435

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
Smallpox
Interventions
BIOLOGICAL

MVA Smallpox Vaccine

Subjects receive two dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) via the SC route using either a syringe and needle or the Stratis™ system. Arm A receives doses via syringe and needle on days 1 and 29; Arm B receives doses via syringe and needle on days 1 and 15, Arm C receives doses via syringe and needle on days 1 and 22, Arm D receives doses via Stratis on days 1 and 29.

Trial Locations (6)

30030-1705

Emory Vaccine Center - The Hope Clinic, Decatur

52242-2600

University of Iowa - Vaccine Research and Education Unit, Iowa City

21201-1544

University of Maryland Medical System - General Clinical Research Center (GCRC), Baltimore

63104-1015

Saint Louis University - Center for Vaccine Development, St Louis

77030-3411

Baylor College of Medicine - Molecular Virology and Microbiology, Houston

98101-1466

Group Health Research Institute - Seattle - Vaccines and Infectious Diseases, Seattle

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01827371 - Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE® | Biotech Hunter | Biotech Hunter