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The Promise of a CMV Vaccine

A single-antigen CMV vaccine provided substantial protection for postpartum women.

Congenital cytomegalovirus (CMV) infection is an important cause of neurological (particularly auditory) impairment in newborns, and the Institute of Medicine has ranked development of a vaccine to prevent congenital CMV infection as a top priority. Women who care for young children (primarily infants and toddlers) have higher risk for CMV acquisition than those who do not. In a manufacturer-supported phase II study of CMV glycoprotein B vaccine with MF59 adjuvant, investigators randomized 464 CMV-seronegative postpartum women to receive three doses of vaccine (at baseline, 1 month, and 6 months) or placebo within 1 year after delivery. Participants were followed for 42 months. CMV acquisition was determined with viral culture, polymerase chain reaction assay, or antibody testing, and women used diaries to report adverse events.

Overall, 8% of vaccine recipients and 14% of placebo recipients acquired CMV during follow-up (P=0.02); vaccine efficacy was 50%. Congenital CMV infection occurred in 1 of 81 infants (1%) born to all vaccine recipients and 3 of 97 infants (3%) born to all placebo recipients (P=0.41). The vaccine was moderately reactogenic: Incidence of myalgias, arthralgias, and chills was higher in the vaccine group than in the placebo group. After the third dose, 3% of vaccine recipients reported severe injection-site pain.

Comment: These results show that even a single-antigen CMV vaccine can provide substantial protection to postpartum women; moreover, such protection might translate into lower rates of congenital CMV infection. In general, this vaccine has lower efficacy than others already on the market — 50% versus at least 90% for most vaccines — and is moderately reactogenic, probably because of the MF59 adjuvant. However, these results raise hopes for development of a successful CMV vaccine.

— Anna Wald, MD, MPH

Published in Journal Watch Women's Health March 18, 2009

Citation(s):

Pass RF et al. Vaccine prevention of maternal cytomegalovirus infection. N Engl J Med 2009 Mar 19; 360:1191.

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