gB/MF59 Vaccine in Preventing Cytomegalovirus Infection in Healthy Adolescent Females
The purpose of this research study is to test the safety of and the body's response to an experimental cytomegalovirus (CMV) vaccine (called gB/MF59 vaccine). Participants will include approximately 400 healthy females, ages 12-17, recruited from adolescent clinics at Cincinnati Children's Hospital Medical Center, Vanderbilt University Medical Center, Baylor College of Medicine, University of Texas School of Public Health, Houston, and the University of Texas Medical Branch at Galveston. Participants will receive 3 doses of vaccine or placebo (saltwater) on a 0, 1, and 6 month schedule. Study procedures will include blood and urine samples. Participants will complete a diary recording temperatures and any side effects experienced. Subjects will be involved in study related procedures for up to 31 months.
Biological: CMV gB vaccine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|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|
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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.
This is a randomized, double-blind, placebo-controlled, phase II study to assess the safety and efficacy of the cytomegalovirus glycoprotein B (gB)/MF59 vaccine in preventing systemic cytomegalovirus infection (CMV) in healthy adolescent females. The study interventions include: intramuscular (IM) injection of the investigational vaccine, CMV gB)/microfluidized adjuvant 59 (MF59), delivered as 20 micrograms in 0.5 mL of vaccine or IM injection of 0.5 mL of saline placebo. Subjects will be randomized (1:1) to receive vaccine or saline placebo. The primary efficacy objective is to assess whether injection with 3 doses of the CMV gB/MF59 vaccine will reduce the acquisition of a systemic CMV infection in healthy CMV-seronegative adolescent females. This will be accomplished by comparing the rates of acquisition of systemic CMV infection, defined as detection of CMV in the urine or blood, between the placebo and CMV vaccine recipients beginning 1 month after the third dose of vaccine. The primary safety objective is to assess the local and systemic effects of immunization and adverse events (AE) with the CMV gB/MF59 vaccine when administered to female adolescents on a 0-, 1-, and 6-month schedule. This will be assessed by comparing the rates of specific local and systemic reactogenicity events and AEs between the vaccine and placebo groups. The endpoint for this trial will be a systemic infection, which will be defined as identification of CMV from the urine (chosen because it is the most common site for isolation of CMV) or blood (chosen because it is the most likely route by which CMV reaches the fetus). Approximately 2400 healthy females, age 12 to 17 years (at time of initial enrollment) will be recruited in order to obtain approximately 400 CMV-seronegative subjects for the vaccine trial. Collection of sera will occur at Screening, Study Day 0, Month 6, Month 7 and every 3 months after Month 7. Collection of urine will occur at Study Day 0, Month 1, Month 2, Month 6, Month 7 and every 3 months after Month 7. Safety/reactogenicity monitoring will consist of solicited signs and symptoms self-reported by memory aid on the day of vaccination and for 6 follow-up days. Unsolicited symptoms will be collected for the 30-day period (± 2 days) after each vaccination and followed to adequate resolution or stabilization. The study duration for each subject will be 31 months: 7 months on the study with 24 months of follow-up beginning 1 month after the last injection. There will be 14 scheduled visits. This study is linked to DMID protocol 06-0043.
|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|
|Baylor College of Medicine - Molecular Virology and Microbiology|
|Houston, Texas, United States, 77030-3411|
|The University of Texas Health Science Center - Pediatrics|
|Houston, Texas, United States, 77030-1501|