{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T22:08:35Z","timestamp":1789164515796,"version":"build-2803163510"},"reference-count":16,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2017,1,30]],"date-time":"2017-01-30T00:00:00Z","timestamp":1485734400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2017,3,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background.<\/jats:title>\n                  <jats:p>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\u2206TMR and ICP4.2, and Matrix-M2 adjuvant.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods.<\/jats:title>\n                  <jats:p>Persons with genital herpes were randomized into 3 dose cohorts to receive 3 intramuscular doses 21 days apart of 10 \u00b5g, 30 \u00b5g, or 100 \u00b5g 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results.<\/jats:title>\n                  <jats:p>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 \u03bcg [P &amp;lt; .001] and from 15.0% to 10.3% for 100 \u00b5g [P &amp;lt; .001]). Lesion rates were also significantly (P &amp;lt; .01) reduced immediately following immunization with 30 \u00b5g or 100 \u00b5g of GEN-003. GEN-003 elicited increases in antigen binding, virus neutralizing antibody, and T-cell responses.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions.<\/jats:title>\n                  <jats:p>GEN-003 had an acceptable safety profile and stimulated humoral and cellular immune responses. GEN-003 at doses of 30 \u00b5g and 100 \u00b5g reduced genital HSV shedding and lesion rates.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration.<\/jats:title>\n                  <jats:p>NCT01667341 (funded by Genocea).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/infdis\/jix004","type":"journal-article","created":{"date-parts":[[2017,1,30]],"date-time":"2017-01-30T13:23:26Z","timestamp":1485782606000},"page":"856-864","source":"Crossref","is-referenced-by-count":67,"title":["Therapeutic Vaccine for Genital Herpes Simplex Virus-2 Infection: Findings From a Randomized Trial"],"prefix":"10.1093","volume":"215","author":[{"given":"David I.","family":"Bernstein","sequence":"first","affiliation":[{"name":"Cincinnati Children\u2019s Hospital Medical Center, University of Cincinnati, Ohio;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Wald","sequence":"first","affiliation":[{"name":"Vaccine and Fred Hutchinson Cancer Research Center, University of Washington, Seattle;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Terri","family":"Warren","sequence":"first","affiliation":[{"name":"Westover Heights Clinic, Portland, Oregon;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth","family":"Fife","sequence":"first","affiliation":[{"name":"Department of Medicine, Indiana University, Indianapolis;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Tyring","sequence":"first","affiliation":[{"name":"University of Texas Health Science Center and"},{"name":"Center for Clinical Studies, Houston, Texas;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Lee","sequence":"first","affiliation":[{"name":"University of Texas Health Science Center and"},{"name":"Center for Clinical Studies, Houston, Texas;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nick","family":"Van Wagoner","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, University of Alabama at Birmingham;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amalia","family":"Magaret","sequence":"first","affiliation":[{"name":"Vaccine and Fred Hutchinson Cancer Research Center, University of Washington, Seattle;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica B.","family":"Flechtner","sequence":"first","affiliation":[{"name":"Genocea Biosciences, Cambridge, Massachusetts; 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