Document Type
Article
Original Publication Date
2005
Journal/Book/Conference Title
The New England Journal of Medicine
Volume
353
Issue
13
First Page
1350
Last Page
1362
DOI of Original Publication
10.1056/NEJMoa043337
Date of Submission
January 2015
Abstract
BACKGROUND
Currently, there is no effective intervention for a primary cytomegalovirus (CMV) infection during pregnancy.
METHODS
We studied pregnant women with a primary CMV infection. The therapy group comprised women whose amniotic fluid contained either CMV or CMV DNA and who were offered intravenous CMV hyperimmune globulin at a dose of 200 U per kilogram of maternal weight. A prevention group, consisting of women with a recent primary infection before 21 weeks' gestation or who declined amniocentesis, was offered monthly hyperimmune globulin (100 U per kilogram intravenously).
RESULTS
In the therapy group, 31 women received hyperimmune globulin, only 1 (3 percent) of whom gave birth to an infant with CMV disease (symptomatic at birth and handicapped at two or more years of age), as compared with 7 of 14 women who did not receive hyperimmune globulin (50 percent). Thus, hyperimmune globulin therapy was associated with a significantly lower risk of congenital CMV disease (adjusted odds ratio, 0.02; 95 percent confidence interval, ¡∞ to 0.15; P<0.001). In the prevention group, 37 women received hyperimmune globulin, 6 (16 percent) of whom had infants with congenital CMV infection, as compared with 19 of 47 women (40 percent) who did not receive hyperimmune globulin. Thus, hyperimmune globulin therapy was associated with a significantly lower risk of congenital CMV infection (adjusted odds ratio, 0.32; 95 percent confidence interval, 0.10 to 0.94; P=0.04). Hyperimmune globulin therapy significantly (P<0.001) increased CMV-specific IgG concentrations and avidity and decreased natural killer cells and HLA-DR+ cells and had no adverse effects.
CONCLUSIONS
Treatment of pregnant women with CMV-specific hyperimmune globulin is safe, and the findings of this nonrandomized study suggest that it may be effective in the treatment and prevention of congenital CMV infection. A controlled trial of this agent may now be appropriate.
Rights
From The New England Journal of Medicine, Nigro, G., Adler, S.P., La Torre, R., et al., Passive immunization during pregnancy for congenital cytomegalovirus infection, Vol. 353, Page 1350, Copyright © 2005 Massachusetts Medical Society. Reprinted with permission.
Is Part Of
VCU Pediatrics Publications
Comments
Originally published at http://dx.doi.org/10.1056/NEJMoa043337