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J Infect Dis. 2018 Nov 5;218(12):1890-1899. doi: 10.1093/infdis/jiy415.

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.

Author information

1
Division of Infectious Diseases, University of Alabama at Birmingham.
2
Department of Medicine, Indiana University, Indianapolis.
3
Department of Medicine, University of North Carolina, Chapel Hill.
4
Division of Infectious Diseases, Cincinnati Children's Hospital, Cincinnati.
5
Westover Heights Clinic, Portland, Oregon.
6
Department of Internal Medicine, Beth Israel Deaconess Hospital, Boston, Massachusetts.
7
Division of Infectious Diseases, University of Illinois, Chicago.
8
Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh.
9
Department of Internal Medicine, University of Utah, Salt Lake City.
10
Center for Clinical Studies, University of Texas Health Science Center; Houston.
11
Medical Center for Clinical Research, San Diego, California.
12
Tekton Research, Austin, Texas.
13
IND 2 Results, Atlanta, Georgia.
14
Genocea Biosciences, Cambridge, Massachusetts.
15
Department of Medicine, University of Washington Fred Hutchinson Cancer Research Center, Seattle, Washington.
16
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.

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.

PMID:
29982727
DOI:
10.1093/infdis/jiy415

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