gB/MF59 Vaccine in Preventing Cytomegalovirus Infection in Healthy Adolescent Females
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00133497|
Recruitment Status : Completed
First Posted : August 23, 2005
Last Update Posted : July 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cytomegalovirus Infections||Biological: MF-59 Drug: Placebo Biological: CMV gB vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||409 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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 Females|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: 20 mcg CMV gB + MF59
200 subjects will receive vaccine CMV gB + MF59.
Microfluoridized adjuvant 59 (MF59).
Biological: CMV gB vaccine
CMV glycoprotein B (gB) delivered as 20 mcg in 0.5 mL of vaccine.
Placebo Comparator: Saline
200 subjects will receive saline placebo.
0.5 mL of saline placebo.
- Efficacy: systemic cytomegalovirus (CMV) infection, defined by the detection of CMV in the urine or blood, which will be evaluated by CMV detection by polymerase chain reaction (PCR). [ Time Frame: Study Day 0, Month 1, Month 2, Month 6, Month 7 and every 3 months after Month 7. ]
- Safety: incidence of local and systemic reactions, as determined by self-reported assessments using a memory aid, adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: Local and systemic reactions within 7 days of vaccination; adverse events (AEs) within the 30 day period after vaccination; serious adverse events (SAEs) observed any time throughout the duration of study. ]
- Efficacy: CMV infections defined as seroconversion to nonvaccine CMV antigens or identification of CMV in the blood or urine. [ Time Frame: Specimens collected every 3 months. ]
- Immunologic: CMV antibody measurements by CMV neutralization, enzyme-linked immunosorbent assay (ELISA), and CMV glycoprotein B (gB) assay. [ Time Frame: Study Day 0, Month 6, Month 7 and every 3 months after Month 7. ]
- Duration and magnitude of CMV replication in the urine and blood as determined from specimens. [ Time Frame: Obtained monthly for 4 months and then every other month for 8 months after identification of CMV infection. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133497
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center - Infectious Diseases|
|Cincinnati, Ohio, United States, 45229-3026|
|United States, Tennessee|
|Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center|
|Nashville, Tennessee, United States, 37232-2573|
|United States, Texas|
|The University of Texas Medical Branch - Sealy Center for Vaccine Development (SCVD)|
|Galveston, Texas, United States, 77555-1121|
|The University of Texas Health Science Center - Pediatrics|
|Houston, Texas, United States, 77030-1501|
|Baylor College of Medicine - Molecular Virology and Microbiology|
|Houston, Texas, United States, 77030-3411|