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TECHNOLOGY

Herpes simplex virus (HSV) infections can cause significant clinical problems and even death in
individuals who are immunodeficient or suffering from disorders of skin integrity. Approximately 80% of
adults in the United States are infected with HSV, of whom 50 to 60 million are infected with HSV-2.
HSV-2 is now the leading cause of genital ulcer disease, and genital HSV-2 infection triples the risk for
sexually acquiring HIV infection. Currently, no medication can prevent primary HSV infections or
decrease the incidence of recurrences. Thus, there is a huge demand for a safe and effective HSV
vaccine.
During the past decade, many studies have focused on the development of various HSV replication-
defective viruses and neuroattenuated mutants as potential vaccines against HSV infection. However, the
ability of these recombinants to establish lifelong latent infection and to co-replicate with wild-type HSV
raises a critical concern for the use of these recombinants in humans, especially as a therapeutic vaccine in
individuals who have been latently infected with HSV. Aiming to significantly increase the safety of HSV
recombinant viral vaccines while retaining the capability of expressing a broad array of viral gene
products, using the T-RExTM (Invitrogen, CA) gene switch technology developed by Dr. Yao and the
dominant-negative mutant polypeptide of HSV-1 origin binding protein UL9, Dr. Yao constructed a novel
class of HSV-1 recombinants (U.S. patent, 6,251,640 B1) with key features of being replication defective,
and capable of inhibiting wild-type HSV-1 and HSV-2 infections (dominant-negative). CJ9-gD is a
prototype of the dominant-negative and replication-defective HSV-1 recombinant viral vaccine that
expresses high-levels of HSV-1 major antigen glycoprotein D (gD) independent of HSV viral DNA
replication. CJ9-gD cannot establish latent infection in vivo and elicits strong and long-lasting HSV-
specific neutralizing Ab as well as CD4+ and CD8+ T-cell responses at levels comparable to those induced
in wild-type HSV-1-immunized mice. Immunization with CJ9-gD elicits strong and effective protective
immune response against HSV-1 infection in both mouse and guinea pig models of HSV-1 infections.
Given these favorable safety and immunological profiles of CJ9-gD and aiming to maximize levels of
gD2 expression, Dr. Yao has recently constructed a dominant-negative and replication-defective HSV-2
recombinant (CJ2-gD2), which expresses gD2 as efficient as wild-type HSV-2 infection, and can exert a
powerful trans-inhibitory effect on the replication of wild type HSV-2 in co-infected cells. CJ2-gD2 is a
more effective vaccine than CJ9-gD in protection against wild-type HSV-2 genital infection and disease
as well as reduction of latent infection by the challenge wild-type HSV-2 in sensory ganglia.
Furthermore, intracerebral injection of high dose of CJ2-gD2 causes no mortality and morbidity in mice.
Collectively, given these demonstrated preclinical immunogenicity and its unique safety profiles, CJ2-
gD2 possess unique advantages over any previously described vaccine candidate in prevention against
HSV-2 genital infection and disease.
Key features of CJ2-gD: Replication-defective and trans-dominant-negative; Avirulent and incapable of
establishment of latent infection; Immediate early overexpression of primary immunogen gD2; Able to
achieve high production titer through use of novel tetracycline repressor gene switch technology; and
ICP0 knock-out reduces cytotoxicity and major cytokine evasion mechanism.


Source: http://www.biotransfer.ca/LOD/lod_2010_08.pdf

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ILLINOIS DEPARTMENT OF PUBLIC HEALTH AIDS DRUG ASSISTANCE PROGRAM (ADAP) FORMULARY as of 6/1/2010 CATEGORY I CATEGORY III REVERSE TRANSCRIPTASE INHIBITORS (RTIs) ANTIBIOTICS didanosine (ddI, dideoxyinosine, Videx, Videx EC) CATEGORY IV (Other) chlorhexidine gluconate (Peridex, PerioGard) testosterone enanthate, I.M only (no Kits) zidovudine (AZT, azidothymid

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