TY - JOUR
T1 - Safety and efficacy of a cytomegalovirus glycoprotein B (gB) vaccine in adolescent girls
T2 - A randomized clinical trial
AU - Bernstein, David I.
AU - Munoz, Flor M.
AU - Callahan, S. Todd
AU - Rupp, Richard
AU - Wootton, Susan H.
AU - Edwards, Kathryn M.
AU - Turley, Christine B.
AU - Stanberry, Lawrence R.
AU - Patel, Shital M.
AU - Mcneal, Monica M.
AU - Pichon, Sylvie
AU - Amegashie, Cyrille
AU - Bellamy, Abbie R.
N1 - Publisher Copyright:
© 2015 Elsevier Ltd.
PY - 2016/1/12
Y1 - 2016/1/12
N2 - 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.
AB - 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.
KW - Adolescent
KW - CMV gB
KW - Cytomegalovirus
KW - Vaccine
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U2 - 10.1016/j.vaccine.2015.11.056
DO - 10.1016/j.vaccine.2015.11.056
M3 - Article
C2 - 26657184
AN - SCOPUS:84955376793
SN - 0264-410X
VL - 34
SP - 313
EP - 319
JO - Vaccine
JF - Vaccine
IS - 3
ER -