The New England Journal of Medicine just published a placebo-controlled, randomized, double-blind study of a vaccine (recombinant CMV envelope glycoprotein B with MF59 adjuvant) in the prevention of maternal infection with with cytomegalovirus (CMV) during pregnancy.
Infection with CMV is major cause of auditory and cognitive impairment in newborns. CMV is actually very common, but when acquired during pregnancy the risk to the developing fetus is very high. Approximately 27,000 CMV infections among pregnant women occur in the United States each year
This study included 464 females between the ages of 14 to 40. The authors randomly assigned 234 subjects to receive the CMV vaccine and 230 subjects to receive placebo. 14% of the females receiving the placebo got CMV infection within one year compared to only 8% of the females receiving the vaccine. 97 infants were born to the mothers in the placebo group and 3 of these infants were infected with CMV (3.1%). In contrast, 81 infants were born to the mothers receiving the vaccine and only 1 infant became infected (1.2%). Surprisingly, the group receiving the vaccines had significantly lower rate of pregnancy than the group receiving the placebo.
Regarding harmful effects of the vaccine to the infants, serious effects were observed in 7 of mothers in the vaccine group and in 8 newborns of mothers in the placebo group. Thus, the vaccine did not lead to more serious events than the placebo. No long-term health effects of the vaccine were reported but the results are provided for events occurring up to 48 months after birth, so the long-term effects are currently unknown.
The study was financed by The National Institute of Allergy and Infectious Diseases, with the support of Sanofi Pasteur and Chiron (now Novartis).
Pass, R., Zhang, C., Evans, A., Simpson, T., Andrews, W., Huang, M., Corey, L., Hill, J., Davis, E., Flanigan, C., & Cloud, G. (2009). Vaccine Prevention of Maternal Cytomegalovirus Infection New England Journal of Medicine, 360 (12), 1191-1199 DOI: 10.1056/NEJMoa0804749
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