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Clinical Trials Resource Center

New Medical Therapies™

Genital Herpes

July 21, 2014

Agenus issued results of a phase II study of HerpV for treatment of genital Herpes Simplex Virus-2 (HSV-2). The randomized, double-blind, multi-center study enrolled 80 subjects with a history of one to nine herpes recurrences within the prior 12 months. 70 subjects received the active treatment, HerpV and QS-21 Stimulon, and 10 subjects received placebo. Three injections of HerpV at a dose of 240μg (includes12μg of a mix of 32 different HSV-2 antigenic peptides) or placebo were given at two week intervals. HSV-2 activity in the genito-urinary tract was monitored by PCR for HSV-2 DNA in genital swabs for 45 days before and after the initial course of three vaccinations. The primary analysis, which looked at viral shedding after the initial three HerpV vaccinations, demonstrated that subjects who received HerpV had a statistically significant reduction in viral shedding (P=0.015; RR=0.85). The results also demonstrate a reduction in viral load of 34% (P=0.08). Placebo patients showed no reduction compared to baseline in either parameter. More than half of those vaccinated developed a robust anti-HSV cytotoxic T-cell immune response, and in those patients there was a statistically significant 75% reduction in viral load (P<0.001; CI: 46.2—88.6%). After the booster shot, HerpV demonstrated a durable reduction in viral shedding approximating 14% (RR=0.86 and CIs: 0.58-1.26) and remains consistent with the reduction in viral shedding observed duing the initial treatment period.

October 21, 2013

Genocea Biosciences reported results of a phase I/IIa trial of GEN-003, an investigational protein subunit vaccine to treat patients with recurrent outbreaks of genital herpes simplex virus type 2 (HSV-2) infection. The double-blind, placebo-controlled dose escalation trial enrolled 143 volunteers with a history of moderate-to-severe recurrent HSV-2 infection at seven clinics in the U.S. Patients were enrolled into one of three dose cohorts (10ug, 30ug or 100ug of each protein) and randomized within cohorts to receive either GEN-003, vaccine antigens without adjuvant or placebo. Patients received three injections of the assigned treatment into an arm muscle at 21 day intervals. Patients who received three doses of GEN-003 had reductions in the frequency of viral shedding of up to 51% (p<0.001). By contrast, those who received a placebo had no decline in viral shedding. T cell immune responses, believed to be important for the control of HSV-2 infection, increased more than twentyfold to one vaccine antigen (ICP4) and more than tenfold to the other (gD2). In addition, GEN-003 increased neutralizing antibodies to the HSV-2 virus fivefold, on average, compared to baseline values.

July 25, 2011

AiCuris issued results from a phase II trial of AIC316 for the prevention of reactivation of genital herpes. This double-blind, randomized, placebo controlled, dose-finding trial enrolled 156 subjects who received AIC316 at doses of 5, 25, or 75 mg once daily or 400 mg once weekly or placebo. The treatment duration was four weeks. The primary endpoint was the suppression of herpes simplex virus replication at 28 days. AIC316 led to a significant reduction of viral shedding in a dose dependent manner. The strongest treatment effect was seen in the 400 mg once weekly and the 75 mg once daily dosing groups. The suppressive effect of AIC316 on viral replication correlated with a significant clinical benefit: the proportion of days with reported genital lesions was reduced from 13.7% to 1.1%; the number of recurrences was also substantially reduced. AIC316 was safe and well tolerated at all doses.

July 26, 2010

Results were reported from a phase IIb trial evaluating Gileads tenofovir gel as a microbicide against HIV and genital herpes. This trial, CAPRISA 004 (Centre for the AIDS Programme of Research in South Africa), enrolled 889 South African women who were 18 to 40 years of age, HIV-negative, sexually active, and at high risk of becoming infected with HIV. The subjects were asked to vaginally insert a first dose of tenofovir gel no more than 12 hours before having sex and to insert a second dose no more than 12 hours after having sex. No more than two doses of gel were used in a 24-hour period. The treatment period was 12 to 18 months. The gel was found to be 39% effective in reducing the risk of becoming infected with HIV during sex and 51% effective in preventing genital herpes infections. The efficacy of tenofovir was greater with increased usage. The women who used the gel more than 80% of the time had a 54% reduction in HIV infections, whereas those who used the gel less than half the time had a 28% reduction in HIV infections.

January 24, 2005

Advanced Biotherapy announced positive preliminary results of an investigational pilot study of its proprietary interferon-gamma antibodies, for the topical treatment of genital lesions associated with herpes simplex virus type 2 (HSV-2) infections. Initial data demonstrated efficacy in the treatment of HSV-2 lesions, with subjects experiencing relief of symptoms of itching and pain within hours of application, and lesion sites experienced re-epithelialization within 3-4 days. This open-label study enrolled subjects with recurrent confirmed HSV-2 lesions at a single site in Russia. Subjects received topical treatment with the drug for several days, based on symptom severity and treatment response. The company indicated that observation with respect to efficacy and clinical outcomes was ongoing, with final results expected in the near future.

January 12, 2004

GlaxoSmithKline reported positive results from a post-marketing trial for Valtrex (valacyclovir), an approved genital herpes agent, testing the indication of reducing viral transmission. Results showed that Valtrex significantly reduced the risk of transmitting herpes infection to a heterosexual partner as compared to placebo. Data showed that suppressive therapy with Valtrex reduced the risk of overall acquisition of the virus by 48% versus placebo (1.9% vs. 3.6%). The randomized, double-blind, placebo-controlled trial enrolled 1,484 healthy, heterosexual, monogamous couples in 21 countries. Results were reported in the Jan. 1st edition of the New England Journal of Medicine.

November 25, 2002

GlaxoSmithKline reported positive results from two phase III trials investigating their genital herpes vaccine. Approximately 73% of treated women, who were free of HSV-1 and HSV-2 infection at the beginning of the trials, were protected against genital herpes disease. The two double-blind, randomized trials of a herpes simplex virus type 2 (HSV-2) glycoprotein-D-subunit vaccine with alum and 3-O-deacylated-monophosphoryl lipid A were conducted in over 2,700 subjects whose regular sexual partners had a history of genital herpes. In Study 1, subjects were seronegative for herpes simplex virus type 1 (HSV-1) and HSV-2 and in Study 2, subjects were of any HSV serologic status. At months 0, 1, and 6, subjects received either vaccine or a control injection and were evaluated for 19 months. The primary end point was the occurrence of genital herpes disease in all subjects in Study 1 and in HSV-2-seronegative female subjects in Study 2. Men treated in either study showed no significant protection.

October 14, 2002

AuRx reported positive results for a phase I/II trial for the treatment of genital herpes. The HSV-2 theracine vaccine produced no adverse events and the side effects were similar to that of the placebo. The vaccine reduced the number of genital herpes cases three fold versus the previous year. In 37.5% of subjects the recurrent episodes of HSV-2 were completely prevented. Of subjects vaccinated, 50% had fewer recurrences and 45% had fewer illness days than the placebo.


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