A randomized controlled trial of a replication defective (gH deletion) herpes simplex virus vaccine for the treatment of recurrent genital herpes among immunocompetent subjects.
BACKGROUND
A replication incompetent herpes virus lacking the glycoprotein H gene has been developed as a potential therapeutic vaccine for genital herpes.


OBJECTIVE
To determine vaccine efficacy on reducing HSV reactivation and clinical disease among immunocompetent persons with recurrent genital HSV-2 infection.


METHODS
Randomized multicenter placebo-controlled trial. Healthy volunteers who had six or more recurrences of genital herpes per year were randomized to receive injections of vaccine at 0 and 8 or 0, 4, and 8 or 0, 2, 4, and 8 weeks or placebo and were followed for subsequent recurrences for 1 year.


RESULTS
The median times to first recurrence of genital herpes (40 days versus 30 days versus 37 days versus 42 days, respectively), mean number of recurrences (3 versus 3 versus 2.4 versus 1.9, respectively), and time to lesion healing of the first recurrence (8 days versus 7.8 days versus 7.4 days versus 7.5 days, respectively), were similar for all treatment groups. Asymptomatic viral shedding was detected by PCR in 61/74 (82%) persons performing daily sample collection following completion of the vaccination series. No differences were noted in the proportion of days with shedding between treatment groups (11.9% versus 17.2% versus 13.1% versus 16.4%, respectively).


CONCLUSIONS
This replication incompetent HSV-2 vaccine lacking the glycoprotein H gene was safe but had no clinical or virologic benefit in the amelioration of genital HSV-2 disease among immunocompetent men and women.
de Bruyn
Guy
G
Program in Infectious Diseases, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Vargas-Cortez
Mauricio
M
Warren
Terri
T
Tyring
Stephen K
SK
Fife
Kenneth H
KH
Lalezari
Jacob
J
Brady
Rebecca C
RC
Shahmanesh
Mohsen
M
Kinghorn
George
G
Beutner
Karl R
KR
Patel
Rajul
R
Drehobl
Margaret A
MA
Horner
Patrick
P
Kurtz
Terrance O
TO
McDermott
Sharon
S
Wald
Anna
A
Corey
Lawrence
L
D000293:Adolescent; D000328:Adult; D018414:CD8-Positive T-Lymphocytes / Q000276:immunology; D005260:Female; D006558:Herpes Genitalis / Q000628:therapy*; D022301:Herpes Simplex Virus Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D013997:Time Factors; D014779:Virus Replication; D017201:Virus Shedding
D022301:Herpes Simplex Virus Vaccines