Accelerated Immunization to Induce Cytomegalovirus Immunity in Stem Cell Donors

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

May 31, 2004

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions
Cytomegalovirus Infections
Interventions
BIOLOGICAL

ALVAC-CMV (vCP260)

"ALVAC-pp65 (vCP260), an attenuated canary pox-based vaccine (Aventis Sanofi Pasteur, Lyon, France), 3 doses (1.0 ml each) delivered intramuscularly in the deltoid muscle.~Sero-negative subjects will receive a total of 3 immunizations to be given day 0, 5 and 10.~Sero-positive subjects will receive a total of 2 immunizations to be given day 0 and 5. (Protocol amendment after findings from the 9/6/2006 interim analysis demonstrated that in the sero-positive group, only 2 vaccinations were required to generate maximum immune response.)"

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH

NCT00353977 - Accelerated Immunization to Induce Cytomegalovirus Immunity in Stem Cell Donors | Biotech Hunter | Biotech Hunter