Therapeutic vaccine for Genital herpes simplex virus-2 infection: Findings from a randomized trial

David I. Bernstein, Anna Wald, Terri Warren, Kenneth Fife, Stephen Tyring, Patricia Lee, Nick Van Wagoner, Amalia Magaret, Jessica B. Flechtner, Sybil Tasker, Jason Chan, Amy Morris, Seth Hetherington

Research output: Contribution to journalArticlepeer-review

25 Scopus citations


Background: Genital herpes simplex virus type 2 (HSV-2) infection causes recurrent lesions and frequent viral shedding. GEN-003 is a candidate therapeutic vaccine containing HSV-2 gD2ΔTMR and ICP4.2, and Matrix-M2 adjuvant. Methods: Persons with genital herpes were randomized into 3 dose cohorts to receive 3 intramuscular doses 21 days apart of 10 μg, 30 μg, or 100 μg of GEN-003, antigens without adjuvant, or placebo. Participants obtained genital swab specimens twice daily for HSV-2 detection and monitored genital lesions for 28-day periods at baseline and at intervals after the last dose. Results. One hundred and thirty-four persons received all 3 doses. Reactogenicity was associated with adjuvant but not with antigen dose or dose number. No serious adverse events were attributed to GEN-003. Compared with baseline, genital HSV-2 shedding rates immediately after dosing were reduced with GEN-003 (from 13.4% to 6.4% for 30 μg [P <.001] and from 15.0% to 10.3% for 100 μg [P μ.001]). Lesion rates were also significantly (P μ.01) reduced immediately following immunization with 30 μg or 100 μg of GEN-003. GEN-003 elicited increases in antigen binding, virus neutralizing antibody, and T-cell responses. Conclusions. GEN-003 had an acceptable safety profile and stimulated humoral and cellular immune responses. GEN-003 at doses of 30 μg and 100 μg reduced genital HSV shedding and lesion rates.

Original languageEnglish (US)
Pages (from-to)856-864
Number of pages9
JournalJournal of Infectious Diseases
Issue number6
StatePublished - Mar 15 2017


  • GEN-003
  • Genital herpes
  • Herpes simplex virus type 2 infection
  • Immunotherapy
  • Therapeutic vaccine

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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