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

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 d

SUBMITTER: Bernstein DI 

PROVIDER: S-EPMC4701617 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature