TRIAL OF RECOMBINANT CMV GB VACCINE IN POSTPARTUM WOMEN

University Of Alabama At Birmingham, Birmingham AL

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Abstract

This study is a phase II, double-blind, placebo controlled clinical trial of subunit vaccine for cytomegalovirus (CMV) infection. The study screens patients for enrollment by obtaining consent for serologic screening of mother and virologic screening (mouth swab viral culture of newborn on postpartum wards of UAB and Cooper Green Hospitals. This screening began June 1, 1999, at UAB and July 6, 1999, at Cooper Green Hospital. Approximately 300 subjects per month were screened until the UAB IRB difficulties in January of 2000. Overall, 2, 14 women have been screened for enrollment. Enrollment in the vaccine trial takes place on the GCRC. Screened subjects who meet enrollment criteria are not eligible until 6 weeks o one year postpartum. As of March 30, 34 subjects had been enrolled and vaccinated on the GCRC. The primary end-point, maternal CMV infection, is detected by quarterly serologic screening for development of antibody to CMV tegument proteins. The vaccine is comprised of recombinant glycoprotein B, an envelope protein. To date none of the enrolled subjects have acquired CMV infection. One subject experienced a serious adverse event, but has since recovered. The annual meeting of the Data and Safety Monitoring Board for this study is May 17, 2000.