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

David I. Bernstein, Flor M. Munoz, S. Todd Callahan, Richard Rupp, Susan H. Wootton, Kathryn M. Edwards, Christine B. Turley, Lawrence R. Stanberry, Shital M. Patel, Monica M. Mcneal, Sylvie Pichon, Cyrille Amegashie, Abbie R. Bellamy

Research output: Contribution to journalArticle

55 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)313-319
Number of pages7
JournalVaccine
Volume34
Issue number3
DOIs
StatePublished - Jan 12 2016

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Cytomegalovirus
randomized clinical trials
glycoproteins
Vaccines
Randomized Controlled Trials
vaccines
Safety
placebos
Placebos
Cytomegalovirus Infections
Simplexvirus glycoprotein B
Glycoproteins
administered dose
vaccine development
seroconversion
urine

Keywords

  • Adolescent
  • CMV gB
  • Cytomegalovirus
  • Vaccine

ASJC Scopus subject areas

  • Immunology and Microbiology(all)
  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • veterinary(all)
  • Molecular Medicine

Cite this

Bernstein, D. I., Munoz, F. M., Callahan, S. T., Rupp, R., Wootton, S. H., Edwards, K. M., ... Bellamy, A. R. (2016). Safety and efficacy of a cytomegalovirus glycoprotein B (gB) vaccine in adolescent girls: A randomized clinical trial. Vaccine, 34(3), 313-319. https://doi.org/10.1016/j.vaccine.2015.11.056

Safety and efficacy of a cytomegalovirus glycoprotein B (gB) vaccine in adolescent girls : A randomized clinical trial. / Bernstein, David I.; Munoz, Flor M.; Callahan, S. Todd; Rupp, Richard; Wootton, Susan H.; Edwards, Kathryn M.; Turley, Christine B.; Stanberry, Lawrence R.; Patel, Shital M.; Mcneal, Monica M.; Pichon, Sylvie; Amegashie, Cyrille; Bellamy, Abbie R.

In: Vaccine, Vol. 34, No. 3, 12.01.2016, p. 313-319.

Research output: Contribution to journalArticle

Bernstein, DI, Munoz, FM, Callahan, ST, Rupp, R, Wootton, SH, Edwards, KM, Turley, CB, Stanberry, LR, Patel, SM, Mcneal, MM, Pichon, S, Amegashie, C & Bellamy, AR 2016, 'Safety and efficacy of a cytomegalovirus glycoprotein B (gB) vaccine in adolescent girls: A randomized clinical trial', Vaccine, vol. 34, no. 3, pp. 313-319. https://doi.org/10.1016/j.vaccine.2015.11.056
Bernstein, David I. ; Munoz, Flor M. ; Callahan, S. Todd ; Rupp, Richard ; Wootton, Susan H. ; Edwards, Kathryn M. ; Turley, Christine B. ; Stanberry, Lawrence R. ; Patel, Shital M. ; Mcneal, Monica M. ; Pichon, Sylvie ; Amegashie, Cyrille ; Bellamy, Abbie R. / Safety and efficacy of a cytomegalovirus glycoprotein B (gB) vaccine in adolescent girls : A randomized clinical trial. In: Vaccine. 2016 ; Vol. 34, No. 3. pp. 313-319.
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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.",
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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

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