Clinical Trial: gB/MF59 Vaccine in Preventing Cytomegalovirus Infection in Healthy Adolescent Females

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Inf

Brief 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 Summary: 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
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

  • 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. ]


Original Primary Outcome:

Current Secondary Outcome:

  • 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. ]


Original Secondary Outcome:

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: August 19, 2005
Date Started: June 2006
Date Completion:
Last Updated: September 19, 2013
Last Verified: September 2013