Recombinant CMV gB Vaccine in Postpartum Women
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if a new cytomegalovirus (CMV) vaccine (CMV
      gB/MF59) can safely prevent mothers from catching CMV infection between pregnancies. This
      study includes 464 women, ages 14-40 years, who delivered a newborn infant within 12 months
      prior to the study. Participants must live within the Birmingham metropolitan area or the
      Tuscaloosa county area and they cannot have had CMV infection previously. CMV vaccine or
      placebo (substance containing no medication) will be given at 3 study visits. Participants
      fill out diary cards for 7 days after each vaccination. Blood samples will be collected.
      Urine samples will be collected several times and pregnancy tests will be performed.
      Participants who tested positive for CMV will have urine, vaginal swab, and saliva specimens
      collected. Each participant will be followed for 3 years after the third dose of vaccine.
      Infants born to participants in the study will be checked for CMV infection.
    

Detailed description: 
      The objective of this double-blind, randomized, placebo-controlled Phase II study is to
      determine whether a recombinant subunit vaccine comprised of cytomegalovirus (CMV) envelope
      glycoprotein B (gB) with MF59 adjuvant can prevent maternal CMV infection between pregnancies
      in a high risk population of women of childbearing age. This study will also permit
      determination of whether the approach used is a feasible one for a large scale efficacy trial
      with prevention of congenital CMV as the endpoint. CMV gB vaccine is comprised of a
      recombinant CMV envelope glycoprotein produced in a Chinese hamster ovary cell line. The CMV
      gB is combined with a novel adjuvant, MF59, a proprietary oil-in-water emulsion. Vaccines
      will be administered at 0, 1, and 6 months by intramuscular injection in the left deltoid.
      Placebo recipients will be given a normal saline solution. Study participants were recruited
      from postpartum wards and from the community. Potential participants were screened for
      antibody to CMV; those who were seronegative were invited to participate in the vaccine
      study. Participants received their initial immunization 1.5 to 12 months postpartum. A total
      of 464, seronegative women who were willing to participate and met enrollment inclusion and
      exclusion criteria were randomized to 1 of 2 groups: Group I participants received 20
      micrograms of gB with MF59; Group II participants received placebo (normal saline). During
      the immunization period local and systemic reactogenicity was assessed by a 7-day diary card
      completed after each dose of vaccine. Adverse events are tabulated. Safety is assessed by
      comparing the local and systemic reactogenicity and adverse event rates between vaccine and
      placebo recipients. Study participants are screened for CMV infection every three months,
      beginning three months after the first dose of vaccine, using a CMV IgG antibody assay with
      preabsorption of sera with purified recombinant CMV gB (vaccine antigen). CMV infection will
      be confirmed by either isolation of virus or detection of CMV DNA in body fluids. After the 3
      dose vaccine schedule has been completed, participants are followed every 3 months. The
      primary endpoint is the time to CMV infection. The rate of congenital CMV infection in
      offspring of immunized mothers is a secondary endpoint. The rate of congenital CMV infection
      will be compared between offspring of vaccine and placebo recipients. Each subject will be
      followed for 3 years from the third dose of vaccine. Specific information will be collected
      on the following pregnancy outcomes: pregnancy report, pregnancy follow-up, abnormal
      pregnancy outcome-mother, and abnormal pregnancy outcome-infant.
    

Intervention name(s): CMV gB vaccine; MF59 adjuvant; Placebo
Intervention type(s): Biological; Drug; Drug
Intervention description(s): CMV gB is combined with a novel adjuvant, MF59, a proprietary oil-in-water emulsion, administered at 0, 1, and 6 months.; Oil-in-water emulsion; Normal saline solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: CMV, Cytomegalovirus, vaccine, women, postpartum