EDITOR’S CHOICE – Therapeutic Vaccine for Genital Herpes Simplex Virus-2 Infection: Findings From a Randomized Trial

May 9, 2017 at 7:54 am

Journal of Infectious Diseases March 2017 V.215 N.6

David I. Bernstein; Anna Wald; Terri Warren; Kenneth Fife; Stephen Tyring

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 gD2∆TMR 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 < .001]). Lesion rates were also significantly (P < .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.

Clinical Trials Registration. NCT01667341 (funded by Genocea).

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Journal of Infectious Diseases March 2017 V.215 N.6

EDITOR’S CHOICE – Vaccination to Reduce Reactivation of Herpes Simplex Virus Type 2

Jeffrey I. Cohen

Herpes simplex virus type 2 (HSV-2) is associated with primary and recurrent genital herpes, disseminated disease or encephalitis in neonates, and severe disease in immunocompromised patients [1]. HSV-2 is also associated with an increased risk of acquisition and transmission of human immunodeficiency virus (HIV). More than 400 million persons are infected with HSV-2 worldwide, and there is no treatment to eliminate the virus….

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Entry filed under: Infecciones virales, Inmunizaciones, Update.

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