gB/MF59 Vaccine in Preventing Cytomegalovirus Infection in Healthy Adolescent Females
Condition: Cytomegalovirus Infections
MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): MF-59; Placebo; CMV gB vaccine
Intervention type(s): Biological; Drug; Biological
Intervention description(s): Microfluoridized adjuvant 59 (MF59).; 0.5 mL of saline placebo.; CMV glycoprotein B (gB) delivered as 20 mcg in 0.5 mL of vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: cytomegalovirus, vaccine, women, children, parent protocol