Effects of Different Doses of GEN-003, a Therapeutic Vaccine for Genital Herpes Simplex Virus-2, on Viral Shedding and Lesions: Results of a Randomized Placebo-Controlled Trial

Nicholas Van Wagoner, Kenneth Fife, Peter A. Leone, David I. Bernstein, Terri Warren, Lori Panther, Richard M. Novak, Richard Beigi, John Kriesel, Stephen Tyring, William Koltun, Gregg Lucksinger, Amy Morris, Bin Zhang, Lisa K. McNeil, Sybil Tasker, Seth Hetherington, Anna Wald

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Abstract

Background: GEN-003 is a candidate therapeutic vaccine for genital herpes simplex virus type 2 (HSV-2). We compared virologic and clinical impact of varying GEN-003 doses. Methods: Adults with symptomatic HSV-2 received placebo or GEN-003 (30 or 60 µg antigen with 25, 50, or 75 µg adjuvant). Viral shedding and lesion rates before vaccination were compared with those measured immediately after vaccination, then at weeks 29-33 and 53-57 after last dose. Results: Compared with baseline shedding rates, the rate ratios for viral shedding immediately after treatment were as follows: 0.82 (95% confidence interval [CI], 0.49-1.36), 30 µg antigen/25 µg adjuvant (30/25) dose; 0.64 (95% CI, 0.45-0.92), 30/50 dose; 0.63 (95% CI, 0.37-1.10), 30/75 dose; 0.56 (95% CI, 0.36-0.88), 60/25 dose; 0.58 (95% CI, 0.38-0.89), 60/50 dose; 0.45 (95% CI, 0.16-0.79), 60/75 dose; and 0.98 (95% CI, 0.76-1.26), placebo. Lesion rate reductions by GEN-003 ranged from 31% to 69%, but lesion rates also decreased among placebo recipients (62%). Reductions in shedding and lesion rate were durable for 12 months for the 60 µg antigen plus 50 or 75 µg adjuvant groups. No serious adverse events occurred with vaccination. Conclusions: The most efficacious vaccine combinations for GEN-003 were the 60 µg/50 µg and 60 µg/75 µg doses.

Original languageEnglish (US)
Pages (from-to)1890-1899
Number of pages10
JournalThe Journal of infectious diseases
Volume218
Issue number12
DOIs
StatePublished - Nov 5 2018

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ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

Cite this

Van Wagoner, N., Fife, K., Leone, P. A., Bernstein, D. I., Warren, T., Panther, L., Novak, R. M., Beigi, R., Kriesel, J., Tyring, S., Koltun, W., Lucksinger, G., Morris, A., Zhang, B., McNeil, L. K., Tasker, S., Hetherington, S., & Wald, A. (2018). Effects of Different Doses of GEN-003, a Therapeutic Vaccine for Genital Herpes Simplex Virus-2, on Viral Shedding and Lesions: Results of a Randomized Placebo-Controlled Trial. The Journal of infectious diseases, 218(12), 1890-1899. https://doi.org/10.1093/infdis/jiy415