BACKGROUND: A replication incompetent herpes virus lacking the glycoprotein H gene has been developed as a potential therapeutic vaccine for genital herpes. GOAL: To determine vaccine efficacy on reducing HSV reactivation and clinical disease among immunocompetent persons with recurrent genital HSV-2 infection. STUDY DESIGN: 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). CONCLUSION: 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.
RCT Entities:
BACKGROUND: A replication incompetent herpes virus lacking the glycoprotein H gene has been developed as a potential therapeutic vaccine for genital herpes. GOAL: To determine vaccine efficacy on reducing HSV reactivation and clinical disease among immunocompetent persons with recurrent genital HSV-2 infection. STUDY DESIGN: 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). CONCLUSION: 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.
Authors: Sita Awasthi; Elizabeth E Zumbrun; Huaxin Si; Fushan Wang; Carolyn E Shaw; Michael Cai; John M Lubinski; Shana M Barrett; John W Balliet; Jessica A Flynn; Danilo R Casimiro; Janine T Bryan; Harvey M Friedman Journal: J Virol Date: 2012-02-08 Impact factor: 5.103
Authors: David J Davido; Eleain M Tu; Hong Wang; Maria Korom; Andreu Gazquez Casals; P Jahnu Reddy; Heba H Mostafa; Benjamin Combs; Steve D Haenchen; Lynda A Morrison Journal: J Virol Date: 2018-08-16 Impact factor: 5.103
Authors: Lesia K Dropulic; Makinna C Oestreich; Harlan L Pietz; Kerry J Laing; Sally Hunsberger; Keith Lumbard; Doreen Garabedian; Siu Ping Turk; Aiying Chen; Ronald L Hornung; Chetan Seshadri; Malisa T Smith; Nancy A Hosken; Sanjay Phogat; Lee-Jah Chang; David M Koelle; Kening Wang; Jeffrey I Cohen Journal: J Infect Dis Date: 2019-08-09 Impact factor: 5.226
Authors: Yo Hoshino; Lesley Pesnicak; Kennichi C Dowdell; Juan Lacayo; Timothy Dudek; David M Knipe; Stephen E Straus; Jeffrey I Cohen Journal: Vaccine Date: 2008-06-02 Impact factor: 3.641