Therapeutic Vaccine for Genital Herpes Simplex Virus-2 Infection: Findings from a Randomized Trial.

Publication Type:

Journal Article


The Journal of infectious diseases (2017)


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 three dose cohorts to receive three intramuscular doses 21 days apart of 10 µg, 30 µg, or 100 µg of GEN-003, antigens without adjuvant, or placebo. Participants obtained genital swabs twice-daily for HSV-2 detection and monitored genital lesions for 28-day periods at baseline and intervals after the last dose.

Results.: One hundred and thirty-four persons received all three doses. Reactogenicity was associated with adjuvant, but not antigen dose or dose number. No serious adverse events were attributed to GEN-003. Compared to baseline, genital HSV-2 shedding rates immediately after dosing were reduced with GEN-003 (30 µg, from 13.4% to 6.4% [p<0.001]; 100 µg, from 15.0% to 10.3% [p<0.001]). Lesion rates were also significantly (p<0.01) reduced immediately following immunization with 30µg or 100µg 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, 30 µg and 100 µg, reduced genital HSV shedding and lesion rates. Clinical Trials number: NCT01667341 (funded by Genocea).