title: A double-blind study of the efficacy and safety of the ICP10deltaPK vaccine against recurrent genital HSV-2 infections.
abstract: A randomized double-blind trial to evaluate the safety of a novel recombinant virus, ICP10deltaPK, for reduction or prevention of recurrent herpes simplex virus type 2 (HSV-2) infection was carried out in public hospitals in Mexico City. Persons having a minimum of 5 documented herpetic recurrences in the previous year were randomized for vaccination. Patients were examined within 72 hours of lesion occurrence. If accepted into the study, the patient was inoculated subcutaneously in the upper deltoid muscle area at days 7, 17, and 28 after initiation of lesion occurrence. Recurrences were recorded by patient diary and physician examination. During the observation period (extending from 10 to 180 days after the last booster dose), recurrences in the vaccine (V) group were prevented completely in 37.5% of the patients, whereas in the placebo (P) group, 100% of the patients had at least one recurrence (P = .068). Vaccinated patients had fewer recurrences (V, 1.58; P, 3.13 [P = .028]). The mean number of illness days was 10 for the vaccine group and 18 for the placebo group (P = .028). Further studies to evaluate this vaccine and its dosimetry for the treatment of genital herpes infections appear warranted.
authors.affiliation: Instituto Nacional de Perinatologia, SSA, Mexico City, Mexico.
authors.forename: Gerardo
authors.initials: G
authors.lastname: Casanova
authors.forename: Rosalia
authors.initials: R
authors.lastname: Cancela
authors.forename: Lourdes
authors.initials: L
authors.lastname: Alonzo
authors.forename: Rosa
authors.initials: R
authors.lastname: Benuto
authors.forename: Maria del Carmen
authors.initials: Mdel C
authors.lastname: Magana
authors.forename: Dennis R
authors.initials: DR
authors.lastname: Hurley
authors.forename: Eugenia
authors.initials: E
authors.lastname: Fishbein
authors.forename: Claudia
authors.initials: C
authors.lastname: Lara
authors.forename: Teresa
authors.initials: T
authors.lastname: Gonzalez
authors.forename: Rebeca
authors.initials: R
authors.lastname: Ponce
authors.forename: Joseph W
authors.initials: JW
authors.lastname: Burnett
authors.forename: Gary J
authors.initials: GJ
authors.lastname: Calton
mesh_terms: D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006558:Herpes Genitalis / Q000175:diagnosis / Q000517:prevention & control*; D022301:Herpes Simplex Virus Vaccines / Q000627:therapeutic use*; D018258:Herpesvirus 2, Human / Q000276:immunology*; D006801:Humans; D007114:Immunization; D008297:Male; D008875:Middle Aged; D017346:Protein Serine-Threonine Kinases / Q000276:immunology*; D012264:Ribonucleotide Reductases / Q000276:immunology*; D012449:Safety; D055502:Secondary Prevention; D016896:Treatment Outcome; D014613:Vaccines, Attenuated / Q000627:therapeutic use
chemical_list: D022301:Herpes Simplex Virus Vaccines; D014613:Vaccines, Attenuated; C100671:ICP10 protein, herpes simplex virus type 2; D012264:Ribonucleotide Reductases; D017346:Protein Serine-Threonine Kinases