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Vaccine. 2016 Jan 12;34(3):313-9. doi: 10.1016/j.vaccine.2015.11.056. Epub 2015 Dec 2.

Safety and efficacy of a cytomegalovirus glycoprotein B (gB) vaccine in adolescent girls: A randomized clinical trial.

Author information

1
Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, United States. Electronic address: David.Bernstein@cchmc.org.
2
Baylor College of Medicine, Houston, TX, United States.
3
Vanderbilt University Medical Center, Nashville, TN, United States.
4
University of Texas Medical Branch at Galveston, Galveston, TX, United States.
5
University of Texas Health Science Center at Houston, Houston, TX, United States.
6
University of Texas Medical Branch at Galveston, Galveston, TX, United States; University of South Carolina School of Medicine, Columbia, SC, United States.
7
University of Texas Medical Branch at Galveston, Galveston, TX, United States; Columbia University, New York Presbyterian Hospital, New York City, NY, United States.
8
Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, United States.
9
Sanofi Pasteur, Marcy L'Etoile, France.
10
The Emmes Corporation, Rockville, MD, United States.

Abstract

BACKGROUND:

Cytomegalovirus (CMV) is a leading cause of congenital infection and an important target for vaccine development.

METHODS:

CMV seronegative girls between 12 and 17 years of age received CMV glycoprotein B (gB) vaccine with MF59 or saline placebo at 0, 1 and 6 months. Blood and urine were collected throughout the study for evidence of CMV infection based on PCR and/or seroconversion to non-vaccine CMV antigens.

RESULTS:

402 CMV seronegative subjects were vaccinated (195 vaccine, 207 placebo). The vaccine was generally well tolerated, although local and systemic adverse events were significantly more common in the vaccine group. The vaccine induced gB antibody in all vaccine recipients with a gB geometric mean titer of 13,400 EU; 95%CI 11,436, 15,700, after 3 doses. Overall, 48 CMV infections were detected (21 vaccine, 27 placebo). In the per protocol population (124 vaccine, 125 placebo) vaccine efficacy was 43%; 95%CI: -36; 76, p=0.20. The most significant difference was after 2 doses, administered as per protocol; vaccine efficacy 45%, 95%CI: -9; 72, p=0.08.

CONCLUSION:

The vaccine was safe and immunogenic. Although the efficacy did not reach conventional levels of significance, the results are consistent with a previous study in adult women (Pass et al. N Engl J Med 2009;360:1191) using the same formulation.

KEYWORDS:

Adolescent; CMV gB; Cytomegalovirus; Vaccine

PMID:
26657184
PMCID:
PMC4701617
DOI:
10.1016/j.vaccine.2015.11.056
[Indexed for MEDLINE]
Free PMC Article

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