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 - Funding Information:
This project has been funded in whole or in part with Federal funds from the NIAID / NIH / HHS under Contract Numbers: HHSN272200800006C ( Cincinnati Children's Hospital Medical Center ); HHSN272200800002C ( Baylor College of Medicine and UT Houston ); HHSN27220080000C ( Vanderbilt University ); HHSN272200800013C (The EMMES Corporation ) and in part with federal funds from the Biomedical Advanced Research and Development Authority, Department of Health and Human Services. At Vanderbilt partial support was also provided by CTSA grant UL1 RR024975-01 from NIH. SHW was also partially supported by KL2 CCTS Supplement Award #3KL2RR024149-05S1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Funding Information:
This project has been funded in whole or in part with Federal funds from the NIAID/NIH/HHSunder Contract Numbers: HHSN272200800006C (Cincinnati Children''s Hospital Medical Center); HHSN272200800002C (Baylor College of Medicine and UT Houston); HHSN27220080000C (Vanderbilt University); HHSN272200800013C (The EMMES Corporation) and in part with federal funds from the Biomedical Advanced Research and Development Authority, Department of Health and Human Services. At Vanderbilt partial support was also provided by CTSA grant UL1 RR024975-01 from NIH. SHW was also partially supported by KL2 CCTS Supplement Award #3KL2RR024149-05S1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.We would like to thank all the volunteers without whom this study would not have been possible. Special thanks to Walla Dempsey, NIAID for her efforts. We would like to acknowledge the extraordinary efforts of the entire staff at each VTEU sites with special thanks to Michelle Dickey, Tara Foltz, and Jessie LePage from Cincinnati Children''s Hospital; Coni Cheesman, Celsa Tajonera, Janet Brown, and Tracey Landford from Baylor College of Medicine; Monika Ruscheinsky-Jaso, from University of Texas at Houston; Gayle Johnson, Shanda Phillips, Julie Anderson, Faith Brendle from Vanderbilt University, Marianne Shafer, Olivia Doherty, Diane Barrett, Karen Waterman and Carrie Harrington from University of Texas at Galveston
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
UR - http://www.scopus.com/inward/record.url?scp=84955376793&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84955376793&partnerID=8YFLogxK
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 -