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

June 19, 2017 at 8:37 am

J Infect Dis 2017 March  215 (6): 856-864.

EDITOR’S CHOICE

David I. Bernstein  Anna Wald  Terri Warren  Kenneth Fife  Stephen Tyring  Patricia Lee Nick Van Wagoner  Amalia Magaret  Jessica B. Flechtner  Sybil Tasker 

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).

PDF

https://oup.silverchair-cdn.com/oup/backfile/Content_public/Journal/jid/215/6/10.1093_infdis_jix004/2/jix004.pdf?Expires=1497965455&Signature=LauwpzltUYdtPj-H4tzcv2QzeU0yI3QyDcTqjGRLhjT~-XCUpAxn5BbzFiTp0ULZNyAvV-WM1DB1W0yaAhUFMS-IBk9m5ZwRyCmL~4xJE2-Lv2rP3ulYPSwj7pBBulLdtF8uAioy6Ux3qfPWSaVsQuvODlSK-jCGvf3xNmq28536uP8sr3mUO12YEXNss8BjjdigOEPGWz8rNL64V5vYHXgBmfSvLArPryGPTLn3gNgPKqU8JHQVUJ~obkccGjIAOfn-XRd8KwzbzLHhlxj0lUZQvqLpNnJs-n~DMe8N9jY0WINI4-gehCrKkfzY3Y4mwZVXXqPioYdoLhIgqqrkAA__&Key-Pair-Id=APKAIUCZBIA4LVPAVW3Q

 

J Infect Dis. March 2017 15;215(6):844-846.             

EDITORIAL COMMENTARY – Vaccination to Reduce Reactivation of Herpes Simplex Virus Type 2.

Cohen JI1.

Author information

1 Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.

A protein vaccine containing two herpes simplex antigens with adjuvant in patients with recurrent genital herpes appeared to be safe and modestly reduced viral shedding and lesion number, but the effect duration is uncertain.

abstract

https://academic.oup.com/jid/article-lookup/doi/10.1093/infdis/jix006

PDF

https://oup.silverchair-cdn.com/oup/backfile/Content_public/Journal/jid/215/6/10.1093_infdis_jix006/2/jix006.pdf?Expires=1497965228&Signature=gwESX5NV2RD2GozSjrMAEFaEYaf3vIjFRiQC2XG8jcqqlijr94CfhTm7efRIQ9I69d77L2-XHMHtpU~1jBDeIib3jVulLhT71~HytY0YIP2Ya4ltHmgyxOiMw5ZJUmnaZUt1P-GXnnPetSISsZQSRAYNtyUqhxd0tBy5ss0sjeGprnnukP13Ea-YA7b~svo3w5gBf4bR8hb5R0Xa7EYbBwbxP1OejrExMz3USyJr2EHFs2igtcWng2HUNtVzwpGIC33SVRgu8EuC31S8afvMRtihFmhZch3iAWEYDtaYoRoAZoMa0BUhMceRIbkk993QeQpz8wioDFuxS7dbZW1GMQ__&Key-Pair-Id=APKAIUCZBIA4LVPAVW3Q

Advertisements

Entry filed under: Infecciones de transmision sexual, Infecciones virales, Inmunizaciones, Update.

Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): study protocol for a randomized controlled trial. Pseudomonas Prosthetic Joint Infections: A Review of 102 Episodes.


Calendar

June 2017
M T W T F S S
« May   Jul »
 1234
567891011
12131415161718
19202122232425
2627282930  

Most Recent Posts


%d bloggers like this: