This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This NIAID supported vaccine clinical trial will test the hypothesis that immunization with a recombinant cytomegalovirus (CMV) envelope glycoprotein (gB) with a novel, proprietary adjuvant (MF59) will protect young women from CMV infection. After obtaining informed consent, young women on postpartum wards of local hospitals are screened for antibody to CMV. Those who are seronegative are invited to participate in the vaccine trial. Seronegative volunteers who meet enrollment criteria are enrolled between 6 weeks and 12 months postpartum. All study vaccine study visits will be conducted in the outpatient clinic space of the GCRC, utilizing GCRC clinical space and nursing personnel. In addition, the GCRC will provide safety laboratory testing in clinical trial participants through UAB Outreach Laboratory. This is a double-blind, randomized, placebo-controlled clinical trial. Participants receive CMVgB/MF59 vaccine or placebo (1:1 randomization) on a 0, 1, and 6 month schedule and are followed for CMV infection every three months for 3 and one-half years. Any babies born to study participants are tested for congenital CMV infection. Study results are reviewed for safety and endpoints by a DSMB at least annually. The primary end-point is maternal CMV infection. Congenital infection in offspring is the main secondary endpoint. In addition to testing vaccine efficacy, this clinical trial will offer an unprecedented opportunity for virologic, immunologic and clinical characterization of primary CMV infection as a large number of cases (60 to 90) are expected in clinical trial participants. Initial target enrollment was 400 subjects, but the total will be increased to replace subjects who did not receive all three study vaccines or were found to be seropositive at enrollment (seroconverted between screening and 1st study vaccine).
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