HSV-2 vaccine shows significant clinical symptoms and viral shedding reductions at six months

March 25, 2014, Genocea Biosciences, Inc.

Updated Phase 1/2a results with GEN-003, a vaccine candidate under development by Genocea Biosciences, Inc. for the treatment of herpes simplex virus type 2 (HSV-2) infection, showed the experimental vaccine to generate highly significant reductions in both the number of clinical lesion days and rate of viral shedding at six months after the final vaccine dose. Genocea, a company pioneering novel T cell vaccines and immunotherapies, reported the results from the ongoing trial of GEN-003 today as an oral presentation at the World Vaccine Congress, being held March 24-26 in Washington, DC.

The ongoing Phase 1/2a double-blind, placebo-controlled study showed that patients treated with GEN-003 at the 30 microgram dose level experienced a 72 percent reduction in lesion days six months after study initiation compared to baseline levels (p<0.001). The results expand upon the positive initial data reported as a late breaker at ICAAC in September 2013 showing that patients treated at the 30 microgram dose level experienced a 50 percent reduction in mean viral shedding from baseline (p<0.001) immediately following three doses, which was maintained at six months (p<0.001). Treatment with GEN-003 was well tolerated overall.

"HSV-2 is an incurable sexually transmitted disease that affects over 500 million people worldwide, and current oral drugs require costly, inconvenient daily dosing to optimally control the painful symptoms of HSV-2 outbreak or to block viral transmission to other individuals," said Jessica Baker Flechtner, PhD, Genocea senior vice president of research, who presented the data. "This is the first time an HSV-2 immunotherapy has shown a significant impact on clinical symptoms, and the fact that GEN-003 has shown durable results six months after study initiation is very encouraging. Results of this initial clinical study of GEN-003, if confirmed by further clinical testing, suggest a compelling best-in-class profile for this therapeutic against HSV-2 infection, that may lead to reductions in both disease transmission and recurrent disease outbreaks."

"These exciting results support the ability of GEN-003 to provide a durable reduction in clinical symptoms, and validate the ATLAS™ platform as a tool for the rational discovery and development of novel vaccines and immunotherapies," said Chip Clark, president and chief executive officer of Genocea. "We expect to announce twelve-month data from this study in mid-2014, and also plan to initiate additional Phase 2 testing of GEN-003 in 2014 to further optimize dosing."

Explore further: Novel vaccine reduces shedding of genital herpes virus

Related Stories

Novel vaccine reduces shedding of genital herpes virus

September 12, 2013
Sexually transmitted infection researchers potentially have reached a milestone in vaccine treatment for genital herpes, according to a report to be presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy ...

NIH launches trial of investigational genital herpes vaccine

November 8, 2013
Researchers have launched an early-stage clinical trial of an investigational vaccine designed to prevent genital herpes disease. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes ...

Quantifying genomic variation of herpes viruses is crucial step toward a vaccine

February 17, 2014
(Medical Xpress)—Unlike scientists studying the flu virus or HIV, researchers working to develop a vaccine for herpes simplex virus don't yet have a library containing thousands of sequenced viral genomes. Relative to the ...

Past HIV vaccine trials reveal new path to success

March 19, 2014
A multi-national research team led by Duke Medicine scientists has identified a subclass of antibodies associated with an effective immune response to an HIV vaccine.

Research shows progress toward a genital herpes vaccine

January 4, 2012
An investigational vaccine protected some women against infection from one of the two types of herpes simplex viruses that cause genital herpes, according to findings in the New England Journal of Medicine.

Influenza vaccine demonstrates favourable immunogenicity and tolerability in clinical testing

January 29, 2014
Singapore's Agency for Science, Technology and Research (A*STAR) and Switzerland's Cytos Biotechnology AG today announced that their influenza vaccine (gH1-Qbeta) met its primary endpoint for immunogenicity (seroconversion ...

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.