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

Vaccine

Volumn 34, Issue 3, 2016, Pages 313-319

  Bernstein, David I ^a   Munoz, Flor M ^b   Callahan, S Todd ^c   Rupp, Richard ^d   Wootton, Susan H ^e   Edwards, Kathryn M ^c   Turley, Christine B ^d,f   Stanberry, Lawrence R ^d,g   Patel, Shital M ^b   Mcneal, Monica M ^a   Pichon, Sylvie ^h   Amegashie, Cyrille ⁱ   Bellamy, Abbie R ⁱ  

^a UNIVERSITY OF CINCINNATI   (United States)

^b BAYLOR COLLEGE OF MEDICINE   (United States)

^c VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^d UNIVERSITY OF TEXAS MEDICAL BRANCH   (United States)

^e UNIVERSITY OF TEXAS   (United States)

^f UNIVERSITY OF SOUTH CAROLINA SCHOOL OF MEDICINE   (United States)

^g Och Spine at New York Presbyterian Hospitals   (United States)

^h SANOFI PASTEUR   (France)

ⁱ EMMES CORPORATION   (United States)

Author keywords

Adolescent; CMV gB; Cytomegalovirus; Vaccine

Indexed keywords

CYTOMEGALOVIRUS GLYCOPROTEIN B; CYTOMEGALOVIRUS VACCINE; MIFAMURTIDE; UNCLASSIFIED DRUG; VIRUS GLYCOPROTEIN; GLYCOPROTEIN B, SIMPLEXVIRUS; IMMUNOLOGICAL ADJUVANT; MF59 OIL EMULSION; PLACEBO; POLYSORBATE; RECOMBINANT VACCINE; SQUALENE; SUBUNIT VACCINE; VIRUS ANTIBODY; VIRUS ANTIGEN; VIRUS DNA; VIRUS ENVELOPE PROTEIN;

ADOLESCENT; ARTICLE; CHILD; CONTROLLED STUDY; CYTOMEGALOVIRUS INFECTION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FEVER; GASTROINTESTINAL DISEASE; HEADACHE; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE REACTION; MYALGIA; NEUROLOGIC DISEASE; NORMAL HUMAN; PATIENT COMPLIANCE; PHASE 2 CLINICAL TRIAL; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; BLOOD; CLINICAL TRIAL; CYTOMEGALOVIRUS INFECTIONS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; GENETICS; IMMUNIZATION; IMMUNOLOGY; PATHOLOGY; URINE; VIROLOGY;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ANTIBODIES, VIRAL; ANTIGENS, VIRAL; BLOOD; CHILD; CYTOMEGALOVIRUS INFECTIONS; CYTOMEGALOVIRUS VACCINES; DNA, VIRAL; DOUBLE-BLIND METHOD; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; IMMUNIZATION SCHEDULE; PLACEBOS; POLYMERASE CHAIN REACTION; POLYSORBATES; SQUALENE; URINE; VACCINES, SUBUNIT; VACCINES, SYNTHETIC; VIRAL ENVELOPE PROTEINS;

EID: 84955376793     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2015.11.056     Document Type: Article

References (23)

1. Kenneson A., Cannon M.J. Review and meta-analysis of the epidemiology of congenital cytomegalovirus (CMV) infection. Rev Med Virol 2007, 17:253-276.
2. Dollard S.C., Grosse S.D., Ross D.S. New estimates of the prevalence of neurological and sensory sequelae and mortality associated with congenital cytomegalovirus infection. Rev Med Virol 2007, 17:355-363.
3. Bate S.L., Dollard S.C., Cannon M.J. Cytomegalovirus seroprevalence in the United States: the national health and nutrition examination surveys, 1988-2004. Clin Infect Dis 2010, 50:1439-1447.
4. Cannon M.J. Congenital cytomegalovirus (CMV) epidemiology and awareness. J Clin Virol 2009, 46(Suppl. 4):S6-S10.
5. Goderis J., De Leenheer E., Smets K., Van Hoecke H., Keymeulen A., Dhooge I. Hearing loss and congenital CMV infection: a systematic review. Pediatrics 2014, 134:972-982.
6. Vaccines for the 21st century: a tool for decisionmaking 2000, National Academy Press, Washington, D.C. D. Stratton, R.S. Lawrence (Eds.).
7. Krause P.R., Bialek S.R., Boppana S.B., Griffiths P.D., Laughlin C.A., Ljungman P., et al. Priorities for CMV vaccine development. Vaccine 2013, 32:4-10.
8. Griffiths P., Plotkin S., Mocarski E., Pass R., Schleiss M., Krause P., et al. Desirability and feasibility of a vaccine against cytomegalovirus. Vaccine 2013, 31(Suppl. 2):B197-B203.
9. Rieder F., Steininger C. Cytomegalovirus vaccine: phase II clinical trial results. Clin Microbiol Infect 2014, 20(Suppl. 5):95-102.
10. McVoy M.A. Cytomegalovirus vaccines. Clin Infect Dis 2013, 57(Suppl. 4):S196-S199.
11. Kharfan-Dabaja M.A., Boeckh M., Wilck M.B., Langston A.A., Chu A.H., Wloch M.K., et al. A novel therapeutic cytomegalovirus DNA vaccine in allogeneic haemopoietic stem-cell transplantation: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis 2012, 12:290-299.
12. Griffiths P.D., Stanton A., McCarrell E., Smith C., Osman M., Harber M., et al. Cytomegalovirus glycoprotein-B vaccine with MF59 adjuvant in transplant recipients: a phase 2 randomised placebo-controlled trial. Lancet 2011, 377:1256-1263.
13. Pass R.F., Zhang C., Evans A., Simpson T., Andrews W., Huang M.L., et al. Vaccine prevention of maternal cytomegalovirus infection. N Engl J Med 2009, 360:1191-1199.
14. Frey S.E., Harrison C., Pass R.F., Yang E., Boken D., Sekulovich R.E., et al. Effects of antigen dose and immunization regimens on antibody responses to a cytomegalovirus glycoprotein B subunit vaccine. J Infect Dis 1999, 180:1700-1703.
15. Limaye A.P., Huang M.L., Leisenring W., Stensland L., Corey L., Boeckh M. Cytomegalovirus (CMV) DNA load in plasma for the diagnosis of CMV disease before engraftment in hematopoietic stem-cell transplant recipients. J Infect Dis 2001, 183:377-382.
16. Boeckh M., Huang M., Ferrenberg J., Stevens-Ayers T., Stensland L., Nichols W.G., et al. Optimization of quantitative detection of cytomegalovirus DNA in plasma by real-time PCR. J Clin Microbiol 2004, 42:1142-1148.
17. Stanberry L.R., Rosenthal S.L., Mills L., Succop P.A., Biro F.M., Morrow R.A., et al. Longitudinal risk of herpes simplex virus (HSV) type 1, HSV type 2, and cytomegalovirus infections among young adolescent girls. Clin Infect Dis 2004, 39:1433-1438.
18. Fowler K.B., Stagno S., Pass R.F., Britt W.J., Boll T.J., Alford C.A. The outcome of congenital cytomegalovirus infection in relation to maternal antibody status. N Engl J Med 1992, 326:663-667.
19. Fowler K.B., Stagno S., Pass R.F. Maternal immunity and prevention of congenital cytomegalovirus infection. JAMA 2003, 289:1008-1011.
20. Adler S.P., Starr S.E., Plotkin S.A., Hempfling S.H., Buis J., Manning M.L., et al. Immunity induced by primary human cytomegalovirus infection protects against secondary infection among women of childbearing age. J Infect Dis 1995, 171:26-32.
21. Pass R.F., Duliege A.M., Boppana S., Sekulovich R., Percell S., Britt W., et al. A subunit cytomegalovirus vaccine based on recombinant envelope glycoprotein B and a new adjuvant. J Infect Dis 1999, 180:970-975.
22. Schleiss M.R., Bourne N., Stroup G., Bravo F.J., Jensen N.J., Bernstein D.I. Protection against congenital cytomegalovirus infection and disease in guinea pigs, conferred by a purified recombinant glycoprotein B vaccine. J Infect Dis 2004, 189:1374-1381.
23. Fu T.M., An Z., Wang D. Progress on pursuit of human cytomegalovirus vaccines for prevention of congenital infection and disease. Vaccine 2014, 32:2525-2533.