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Experimental Vaccine Shows Promise in Preventing Cytomegalovirus Infection BETHESDA, Md -- March 19, 2009 -- Women who received an experimental cytomegalovirus (CMV) vaccine were 50% less likely to later become infected with CMV than were women who received a saline injection, according to a study published in the March 19 issue of the New England Journal of Medicine. "This trial demonstrates that a statistically significant degree of protection against maternal CMV can be achieved through vaccination," said lead researcher Robert Pass, MD, University of Alabama, Birmingham, Alabama. "This is an important step along the path towards the ultimate goal -- a vaccine that can protect infants from congenital CMV infection." He noted that a larger trial would be needed to conclusively prove the efficacy of any candidate CMV vaccine for this purpose. "However, for everyone interested in CMV vaccine development, this is an encouraging result." The trial evaluated an experimental vaccine made from a single CMV protein, glycoprotein B and an experimental adjuvant, MF59. Researchers invited healthy women aged 14 to 40 years who had given birth at the University of Alabama or at the University of Alabama College of Community Health Sciences, Tuscaloosa, Alabama, to participate in the trial. After nearly 7 years, the trial reached its enrollment goal. A total of 441 CMV-negative women, divided at random to receive the candidate vaccine or a saline injection, were evaluated. Vaccinations were given to women within 1 year after they had given birth. Most women received 3 doses of trial vaccine or saline injection; all received at least 1 dose. All volunteers agreed to use birth control until 2 months after receiving the final injection. In the final analysis, women who received the trial vaccine were significantly more likely to remain uninfected throughout the 42-month follow-up period than those who received the saline injection. Of the vaccine recipients, 8% (18 of 225) eventually became infected with CMV, while 14% of saline injection recipients (31 out of 216) acquired a CMV infection by the end of the trial. There were no significant differences between the trial vaccine group and the saline injection group in frequency of fever, nausea, fatigue or rash. Most of the body-wide reactions were mild and lasted less than a day. Local reactions such as pain, redness, and swelling at the injection site occurred more often in the vaccine group than in the group receiving saline injection and lasted less than a day. SOURCE: National Institutes of Health E-mail this page to a friend or colleague! To print, use this version