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Clinical Trial
. 2011 Nov 3;29(47):8520-9.
doi: 10.1016/j.vaccine.2011.09.046. Epub 2011 Sep 21.

Safety and Immunogenicity of Long HSV-2 Peptides Complexed With rhHsc70 in HSV-2 Seropositive Persons

Affiliations
Clinical Trial

Safety and Immunogenicity of Long HSV-2 Peptides Complexed With rhHsc70 in HSV-2 Seropositive Persons

Anna Wald et al. Vaccine. .

Abstract

HSV-2, the primary causative agent of genital herpes, establishes latency in sensory ganglia and reactivates causing recurrent lesions and viral shedding. Induction or expansion of CD4(+) and CD8(+) T cell responses are expected to be important for a successful therapeutic vaccine against HSV-2. A candidate vaccine consisting of 32 synthetic 35mer HSV-2 peptides non-covalently complexed with recombinant human Hsc70 protein (named HerpV, formerly AG-707) was tested for safety and immunogenicity in a Phase I study. These peptides are derived from 22 HSV-2 proteins representative of all phases of viral replication. Thirty-five HSV-2 infected participants were randomized and treated in one of four groups: HerpV+QS-21 (saponin adjuvant), HerpV, QS-21, or vehicle. The vaccine was well tolerated and safe. All seven participants with evaluable samples who were administered HerpV with QS-21 demonstrated a statistically significant CD4(+) T cell response to HSV-2 antigens, and the majority of such participants demonstrated a statistically significant CD8(+) T cell response as well. To our knowledge, this is the first candidate vaccine against HSV-2 to demonstrate a broad CD4(+) and CD8(+) T cell response in HSV-2(+) participants, and the first HSP-based vaccine to show immune responses against viral antigens in humans.

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