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Vaccine. 2019 Oct 8;37(43):6470-6477. doi: 10.1016/j.vaccine.2019.08.077. Epub 2019 Sep 9.

Intranasal nanoemulsion-adjuvanted HSV-2 subunit vaccine is effective as a prophylactic and therapeutic vaccine using the guinea pig model of genital herpes.

Author information

1
Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. Electronic address: david.bernstein@cchmc.org.
2
Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
3
BlueWillow Biologics, Ann Arbor, MI, USA.
4
University of Pennsylvania, Philadelphia, PA, USA.
5
BlueWillow Biologics, Ann Arbor, MI, USA. Electronic address: ali.fattom@bluewillow.com.

Abstract

Genital herpes is a sexually transmitted disease representing a major global health concern. Currently, there is no approved vaccine and existing antiviral therapies exhibit limited efficacy. Herein, we describe an intranasal (IN) vaccine comprised of HSV-2 surface glycoproteins gD2 and gB2 formulated in a nanoemulsion adjuvant (NE01-gD2/gB2). Using the HSV-2 genital herpes guinea pig model, we demonstrate that IN NE01-gD2/gB2 induces higher levels of neutralizing antibody compared to a monovalent IN NE01-gD2 vaccine, but less than an intramuscular (IM) Alum/MPL-gD2 vaccine. Following intravaginal (IVag) challenge with HSV-2, the group immunized with IN NE01-gD2/gB2 exhibited significantly reduced acute and recurrent disease scores compared to placebo recipients. Significantly, latent virus was only detected in the dorsal root ganglia of 1 of 12 IN NE01-gD2/gB2-vaccinated animals compared to 11 of 12 placebo recipient. In the therapeutic model, IN NE01-gD2/gB2 immunized guinea pigs exhibited a significant reduction in the recurrent lesions scores (64%, p < 0.01), number of animal days with disease (64%, p < 0.01), number of animals with viral shedding (50%, p < 0.04) and reduction in virus positive vaginal swabs (56%, p < 0.04), These data suggests that the treatment may be effective in treating chronic disease and minimizing virus transmission. These results warrant advancing the development of IN NE01-gD2/gB2 as both a prophylactic and therapeutic vaccine against HSV-2.

KEYWORDS:

Genital herpes; Herpes simplex virus type 2; NanoVax; Nanoemulsion; Vaccine

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