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Previous Volume 360:1191-1199 March 19, 2009 Number 12 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Editorial by Dekker, C. L. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Congenital infection with cytomegalovirus (CMV) is an important cause of hearing, cognitive, and motor impairments in newborns.

Methods In this phase 2, placebo-controlled, randomized, double-blind trial, we evaluated a vaccine consisting of recombinant CMV envelope glycoprotein B with MF59 adjuvant, as compared with placebo. Three doses of the CMV vaccine or placebo were given at 0, 1, and 6 months to CMV-seronegative women within 1 year after they had given birth. We tested for CMV infection in the women in quarterly tests during a 42-month period, using an assay for IgG antibodies against CMV proteins other than glycoprotein B. Infection was confirmed by virus culture or immunoblotting. The primary end point was the time until the detection of CMV infection.

Results We randomly assigned 234 subjects to receive the CMV vaccine and 230 subjects to receive placebo. A scheduled interim analysis led to a stopping recommendation because of vaccine efficacy. After a minimum of 1 year of follow-up, there were 49 confirmed infections, 18 in the vaccine group and 31 in the placebo group. Kaplan–Meier analysis showed that the vaccine group was more likely to remain uninfected during a 42-month period than the placebo group (P=0.02). Vaccine efficacy was 50% (95% confidence interval, 7 to 73) on the basis of infection rates per 100 person-years. One congenital infection among infants of the subjects occurred in the vaccine group, and three infections occurred in the placebo group. There were more local reactions (pain, erythema, induration, and warmth) and systemic reactions (chills, arthralgias, and myalgias) in the vaccine group than in the placebo group.

Conclusions CMV glycoprotein B vaccine has the potential to decrease incident cases of maternal and congenital CMV infection. (ClinicalTrials.gov number, NCT00125502 [ClinicalTrials.gov] .)

Source Information

From the Departments of Pediatrics (R.F.P., C.Z., T.S., J.H.), Obstetrics and Gynecology (W.A.), and Medicine (C.F., G.C.), University of Alabama at Birmingham, Birmingham; the Department of Pediatrics, University of Alabama College of Community Health Sciences, Tuscaloosa (A.E., E.D.); and the Departments of Laboratory Medicine (M.-L.H., L.C.) and Medicine (L.C.), University of Washington; and the Fred Hutchinson Cancer Research Center (M.-L.H., L.C.) — both in Seattle.

Address reprint requests to Dr. Pass at Children's Hospital, 1600 7th Ave. S., CHB 309, Birmingham, AL 35233, or at rpass{at}peds.uab.edu.

Full Text of this Article

This article has been cited by other articles:

• (2009). All you need to read in the other general journals. BMJ 338: b1181-b1181 [Full Text]  
• Dekker, C. L., Arvin, A. M. (2009). One Step Closer to a CMV Vaccine. NEJM 360: 1250-1252 [Full Text]  
• (2009). The Promise of a CMV Vaccine. JWatch Women's Health 2009: 1-1 [Full Text]