Cytomegalovirus Cell-Mediated Immunity
Completed
Conditions studied: Cytomegalovirus Infections
In brief
Cytomegalovirus (CMV) is an important cause of illness and occasional deaths in infants who catch the virus before they are born, in newborns, and in children and adults who have weak immune systems. The purpose of this study is to look at how the CMV vaccine works in the blood. This study is being done along with the main CMV gB/MF59 vaccine study that looks at how the overall body reacts to the vaccine. Participants will include up to 100 healthy adolescent female subjects aged 12 to 17 years who were vaccinated in study 04-039 and 100 subjects that were screened for 04-039 to participate as controls. Study procedures will include up to 6 blood draws taken over a 13 month period. Participation will be about 31 months (unless the patient enrolls into the shedding study).
Key facts
- Study ID
- NCT00815165
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 165
- Starts
- 2006-06-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2013-09-09
Who can join
Age: 12 and older, up to 17. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Parent/legal guardian and subjects who understand and sign the assent as well as consent forms for this study.
- Subjects who qualify for the Division of Microbiology and Infectious Diseases, NIAID, NIH (DMID) study 04-039, "A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Safety and Efficacy of the Cytomegalovirus gB/MF59 Vaccine in Preventing Systemic Cytomegalovirus Infection in Healthy Adolescent," will be eligible for the initial pre-vaccination blood draw.
- Subjects who meet all inclusion criteria for the DMID 04-039 study and who are vaccinated will be allowed to participate in the remaining portions of this study.
You may not qualify if…
- All subjects who are ineligible for the main DMID 04-039 study will not be eligible for the cell-mediated immunity sub-study.
Where it is running
- Cincinnati Children's Hospital Medical Center - Infectious Diseases — Cincinnati, Ohio, United States
- Vanderbilt University - Pediatric - Infectious Diseases — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.