A randomized controlled trial of a replication defective (gH deletion) herpes simplex virus vaccine for the treatment of recurrent genital herpes among immunocompetent subjects

Guy De Bruyn, Mauricio Vargas-Cortez, Terri Warren, Stephen K. Tyring, Kenneth Fife, Jacob Lalezari, Rebecca C. Brady, Mohsen Shahmanesh, George Kinghorn, Karl R. Beutner, Rajul Patel, Margaret A. Drehobl, Patrick Horner, Terrance O. Kurtz, Sharon McDermott, Anna Wald, Lawrence Corey

Research output: Contribution to journalArticle

62 Citations (Scopus)

Abstract

Background: A replication incompetent herpes virus lacking the glycoprotein H gene has been developed as a potential therapeutic vaccine for genital herpes. Goal: To determine vaccine efficacy on reducing HSV reactivation and clinical disease among immunocompetent persons with recurrent genital HSV-2 infection. Study design: Randomized multicenter placebo-controlled trial. Healthy volunteers who had six or more recurrences of genital herpes per year were randomized to receive injections of vaccine at 0 and 8 or 0, 4, and 8 or 0, 2, 4, and 8 weeks or placebo and were followed for subsequent recurrences for 1 year. Results: The median times to first recurrence of genital herpes (40 days versus 30 days versus 37 days versus 42 days, respectively), mean number of recurrences (3 versus 3 versus 2.4 versus 1.9, respectively), and time to lesion healing of the first recurrence (8 days versus 7.8 days versus 7.4 days versus 7.5 days, respectively), were similar for all treatment groups. Asymptomatic viral shedding was detected by PCR in 61/74 (82%) persons performing daily sample collection following completion of the vaccination series. No differences were noted in the proportion of days with shedding between treatment groups (11.9% versus 17.2% versus 13.1% versus 16.4%, respectively). Conclusion: This replication incompetent HSV-2 vaccine lacking the glycoprotein H gene was safe but had no clinical or virologic benefit in the amelioration of genital HSV-2 disease among immunocompetent men and women.

Original languageEnglish
Pages (from-to)914-920
Number of pages7
JournalVaccine
Volume24
Issue number7
DOIs
StatePublished - Feb 13 2006

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Herpes Simplex Virus Vaccines
Herpes Genitalis
herpes simplex
genitalia
Randomized Controlled Trials
Human Herpesvirus 2
vaccines
Recurrence
viruses
Vaccines
placebos
glycoproteins
Glycoproteins
Placebos
Virus Shedding
Therapeutics
viral shedding
Genes
volunteers
Healthy Volunteers

Keywords

  • Genital herpes
  • Herpes simplex virus
  • Randomized controlled trial
  • Therapeutic vaccine

ASJC Scopus subject areas

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

Cite this

A randomized controlled trial of a replication defective (gH deletion) herpes simplex virus vaccine for the treatment of recurrent genital herpes among immunocompetent subjects. / De Bruyn, Guy; Vargas-Cortez, Mauricio; Warren, Terri; Tyring, Stephen K.; Fife, Kenneth; Lalezari, Jacob; Brady, Rebecca C.; Shahmanesh, Mohsen; Kinghorn, George; Beutner, Karl R.; Patel, Rajul; Drehobl, Margaret A.; Horner, Patrick; Kurtz, Terrance O.; McDermott, Sharon; Wald, Anna; Corey, Lawrence.

In: Vaccine, Vol. 24, No. 7, 13.02.2006, p. 914-920.

Research output: Contribution to journalArticle

De Bruyn, G, Vargas-Cortez, M, Warren, T, Tyring, SK, Fife, K, Lalezari, J, Brady, RC, Shahmanesh, M, Kinghorn, G, Beutner, KR, Patel, R, Drehobl, MA, Horner, P, Kurtz, TO, McDermott, S, Wald, A & Corey, L 2006, 'A randomized controlled trial of a replication defective (gH deletion) herpes simplex virus vaccine for the treatment of recurrent genital herpes among immunocompetent subjects', Vaccine, vol. 24, no. 7, pp. 914-920. https://doi.org/10.1016/j.vaccine.2005.08.088
De Bruyn, Guy ; Vargas-Cortez, Mauricio ; Warren, Terri ; Tyring, Stephen K. ; Fife, Kenneth ; Lalezari, Jacob ; Brady, Rebecca C. ; Shahmanesh, Mohsen ; Kinghorn, George ; Beutner, Karl R. ; Patel, Rajul ; Drehobl, Margaret A. ; Horner, Patrick ; Kurtz, Terrance O. ; McDermott, Sharon ; Wald, Anna ; Corey, Lawrence. / A randomized controlled trial of a replication defective (gH deletion) herpes simplex virus vaccine for the treatment of recurrent genital herpes among immunocompetent subjects. In: Vaccine. 2006 ; Vol. 24, No. 7. pp. 914-920.
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abstract = "Background: A replication incompetent herpes virus lacking the glycoprotein H gene has been developed as a potential therapeutic vaccine for genital herpes. Goal: To determine vaccine efficacy on reducing HSV reactivation and clinical disease among immunocompetent persons with recurrent genital HSV-2 infection. Study design: Randomized multicenter placebo-controlled trial. Healthy volunteers who had six or more recurrences of genital herpes per year were randomized to receive injections of vaccine at 0 and 8 or 0, 4, and 8 or 0, 2, 4, and 8 weeks or placebo and were followed for subsequent recurrences for 1 year. Results: The median times to first recurrence of genital herpes (40 days versus 30 days versus 37 days versus 42 days, respectively), mean number of recurrences (3 versus 3 versus 2.4 versus 1.9, respectively), and time to lesion healing of the first recurrence (8 days versus 7.8 days versus 7.4 days versus 7.5 days, respectively), were similar for all treatment groups. Asymptomatic viral shedding was detected by PCR in 61/74 (82{\%}) persons performing daily sample collection following completion of the vaccination series. No differences were noted in the proportion of days with shedding between treatment groups (11.9{\%} versus 17.2{\%} versus 13.1{\%} versus 16.4{\%}, respectively). Conclusion: This replication incompetent HSV-2 vaccine lacking the glycoprotein H gene was safe but had no clinical or virologic benefit in the amelioration of genital HSV-2 disease among immunocompetent men and women.",
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AU - Vargas-Cortez, Mauricio

AU - Warren, Terri

AU - Tyring, Stephen K.

AU - Fife, Kenneth

AU - Lalezari, Jacob

AU - Brady, Rebecca C.

AU - Shahmanesh, Mohsen

AU - Kinghorn, George

AU - Beutner, Karl R.

AU - Patel, Rajul

AU - Drehobl, Margaret A.

AU - Horner, Patrick

AU - Kurtz, Terrance O.

AU - McDermott, Sharon

AU - Wald, Anna

AU - Corey, Lawrence

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N2 - Background: A replication incompetent herpes virus lacking the glycoprotein H gene has been developed as a potential therapeutic vaccine for genital herpes. Goal: To determine vaccine efficacy on reducing HSV reactivation and clinical disease among immunocompetent persons with recurrent genital HSV-2 infection. Study design: Randomized multicenter placebo-controlled trial. Healthy volunteers who had six or more recurrences of genital herpes per year were randomized to receive injections of vaccine at 0 and 8 or 0, 4, and 8 or 0, 2, 4, and 8 weeks or placebo and were followed for subsequent recurrences for 1 year. Results: The median times to first recurrence of genital herpes (40 days versus 30 days versus 37 days versus 42 days, respectively), mean number of recurrences (3 versus 3 versus 2.4 versus 1.9, respectively), and time to lesion healing of the first recurrence (8 days versus 7.8 days versus 7.4 days versus 7.5 days, respectively), were similar for all treatment groups. Asymptomatic viral shedding was detected by PCR in 61/74 (82%) persons performing daily sample collection following completion of the vaccination series. No differences were noted in the proportion of days with shedding between treatment groups (11.9% versus 17.2% versus 13.1% versus 16.4%, respectively). Conclusion: This replication incompetent HSV-2 vaccine lacking the glycoprotein H gene was safe but had no clinical or virologic benefit in the amelioration of genital HSV-2 disease among immunocompetent men and women.

AB - Background: A replication incompetent herpes virus lacking the glycoprotein H gene has been developed as a potential therapeutic vaccine for genital herpes. Goal: To determine vaccine efficacy on reducing HSV reactivation and clinical disease among immunocompetent persons with recurrent genital HSV-2 infection. Study design: Randomized multicenter placebo-controlled trial. Healthy volunteers who had six or more recurrences of genital herpes per year were randomized to receive injections of vaccine at 0 and 8 or 0, 4, and 8 or 0, 2, 4, and 8 weeks or placebo and were followed for subsequent recurrences for 1 year. Results: The median times to first recurrence of genital herpes (40 days versus 30 days versus 37 days versus 42 days, respectively), mean number of recurrences (3 versus 3 versus 2.4 versus 1.9, respectively), and time to lesion healing of the first recurrence (8 days versus 7.8 days versus 7.4 days versus 7.5 days, respectively), were similar for all treatment groups. Asymptomatic viral shedding was detected by PCR in 61/74 (82%) persons performing daily sample collection following completion of the vaccination series. No differences were noted in the proportion of days with shedding between treatment groups (11.9% versus 17.2% versus 13.1% versus 16.4%, respectively). Conclusion: This replication incompetent HSV-2 vaccine lacking the glycoprotein H gene was safe but had no clinical or virologic benefit in the amelioration of genital HSV-2 disease among immunocompetent men and women.

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KW - Herpes simplex virus

KW - Randomized controlled trial

KW - Therapeutic vaccine

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