HSV529 is a vaccine candidate that is classified as a replication-defective virus, where the virus possesses all the components of the wild-type HSV virus with the exception of two proteins UL5 and UL29 that are involved in viral DNA replication.
HSV529 is indicated to treat herpes simplex virus (HSV).
The vaccine candidate was delivered by intramuscular injections.
Clinical Trial NCT01915212: Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection
The goals of the study are to determine:
- the safety of HSV529 vaccine in persons with or without HSV infection
- the ability of the vaccine to elicit immune responses to HSV-2
- including virus-specific antibodies and T cell responses to the virus
Three groups of 20 subjects each will be randomized and will receive 3 doses of HSV529 (15 subjects per group) or saline placebo injection (5 subjects per group).
Each subject will be followed for 6 months after the last dose of vaccine.
The 3 groups will be (a) subjects who were infected with HSV-2 in the past but may or may not have been infected with HSV-1 (HSV-1+/-/HSV-2+), (b) subjects who have been infected only with HSV-1 (HSV-1+/HSV-2-), and (c) subjects who have not been infected with HSV-1 or HSV-2 (HSV-1-/HSV-2-).
Vaccine or placebo will be administered on Day 0 and approximately 1 month and 6 months after enrollment.