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A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection.

Publication ,  Journal Article
Hughes, BL; Clifton, RG; Rouse, DJ; Saade, GR; Dinsmoor, MJ; Reddy, UM; Pass, R; Allard, D; Mallett, G; Fette, LM; Gyamfi-Bannerman, C ...
Published in: N Engl J Med
July 29, 2021

BACKGROUND: Primary cytomegalovirus (CMV) infection during pregnancy carries a risk of congenital infection and possible severe sequelae. There is no established intervention for preventing congenital CMV infection. METHODS: In this multicenter, double-blind trial, pregnant women with primary CMV infection diagnosed before 24 weeks' gestation were randomly assigned to receive a monthly infusion of CMV hyperimmune globulin (at a dose of 100 mg per kilogram of body weight) or matching placebo until delivery. The primary outcome was a composite of congenital CMV infection or fetal or neonatal death if CMV testing of the fetus or neonate was not performed. RESULTS: From 2012 to 2018, a total of 206,082 pregnant women were screened for primary CMV infection before 23 weeks of gestation; of the 712 participants (0.35%) who tested positive, 399 (56%) underwent randomization. The trial was stopped early for futility. Data on the primary outcome were available for 394 participants; a primary outcome event occurred in the fetus or neonate of 46 of 203 women (22.7%) in the group that received hyperimmune globulin and of 37 of 191 women (19.4%) in the placebo group (relative risk, 1.17; 95% confidence interval [CI] 0.80 to 1.72; P = 0.42). Death occurred in 4.9% of fetuses or neonates in the hyperimmune globulin group and in 2.6% in the placebo group (relative risk, 1.88; 95% CI, 0.66 to 5.41), preterm birth occurred in 12.2% and 8.3%, respectively (relative risk, 1.47; 95% CI, 0.81 to 2.67), and birth weight below the 5th percentile occurred in 10.3% and 5.4% (relative risk, 1.92; 95% CI, 0.92 to 3.99). One participant in the hyperimmune globulin group had a severe allergic reaction to the first infusion. Participants who received hyperimmune globulin had a higher incidence of headaches and shaking chills while receiving infusions than participants who received placebo. CONCLUSIONS: Among pregnant women, administration of CMV hyperimmune globulin starting before 24 weeks' gestation did not result in a lower incidence of a composite of congenital CMV infection or perinatal death than placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences; ClinicalTrials.gov number, NCT01376778.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

July 29, 2021

Volume

385

Issue

5

Start / End Page

436 / 444

Location

United States

Related Subject Headings

  • Treatment Failure
  • Pregnancy Complications, Infectious
  • Pregnancy
  • Infusions, Intravenous
  • Infectious Disease Transmission, Vertical
  • Infant, Newborn
  • Infant Mortality
  • Infant
  • Incidence
  • Immunoglobulins, Intravenous
 

Citation

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Hughes, B. L., Clifton, R. G., Rouse, D. J., Saade, G. R., Dinsmoor, M. J., Reddy, U. M., … Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network. (2021). A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection. N Engl J Med, 385(5), 436–444. https://doi.org/10.1056/NEJMoa1913569
Hughes, Brenna L., Rebecca G. Clifton, Dwight J. Rouse, George R. Saade, Mara J. Dinsmoor, Uma M. Reddy, Robert Pass, et al. “A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection.N Engl J Med 385, no. 5 (July 29, 2021): 436–44. https://doi.org/10.1056/NEJMoa1913569.
Hughes BL, Clifton RG, Rouse DJ, Saade GR, Dinsmoor MJ, Reddy UM, et al. A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection. N Engl J Med. 2021 Jul 29;385(5):436–44.
Hughes, Brenna L., et al. “A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection.N Engl J Med, vol. 385, no. 5, July 2021, pp. 436–44. Pubmed, doi:10.1056/NEJMoa1913569.
Hughes BL, Clifton RG, Rouse DJ, Saade GR, Dinsmoor MJ, Reddy UM, Pass R, Allard D, Mallett G, Fette LM, Gyamfi-Bannerman C, Varner MW, Goodnight WH, Tita ATN, Costantine MM, Swamy GK, Gibbs RS, Chien EK, Chauhan SP, El-Sayed YY, Casey BM, Parry S, Simhan HN, Napolitano PG, Macones GA, Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network. A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection. N Engl J Med. 2021 Jul 29;385(5):436–444.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

July 29, 2021

Volume

385

Issue

5

Start / End Page

436 / 444

Location

United States

Related Subject Headings

  • Treatment Failure
  • Pregnancy Complications, Infectious
  • Pregnancy
  • Infusions, Intravenous
  • Infectious Disease Transmission, Vertical
  • Infant, Newborn
  • Infant Mortality
  • Infant
  • Incidence
  • Immunoglobulins, Intravenous