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Vanderbilt University Medical Center Launches Genital Herpes Vaccine Trial

Sep. 27, 2004, 12:29 PM

Health surveys conducted by the Centers for Disease Control and Prevention and other governmental health agencies estimate at least 45 million U.S. citizens, ages 12 and older, crossing all races and socioeconomic levels, are infected with genital herpes. This figure represents one-fifth of the nation’s population.

For adults, having genital herpes can be considered a social scourge. But being infected with the herpes simplex virus typically does not pose a significant health threat. However, in women of child-bearing age, transmission of the herpes simplex virus during delivery can cause potentially fatal infections in newborns.

Like other sexually-transmitted diseases- the most realistic answer to curbing a growing number of Americans infected with genital herpes lies in an effective preventative vaccine.

Vanderbilt University Medical Center researchers are launching a clinical trial of Herpavac, a new genital herpes vaccine that has proven effective in previous clinical trials in preventing the spread of the herpes simplex virus in women.

"We are attempting to enroll women, ages 18 to 30, who have never had genital herpes, and also have never had herpes simplex type 1, which is typically the type of herpes that causes oral cold sores," said Jana Wheeler, MSN, nurse practitioner in the division of Pediatric Infectious Diseases.

Wheeler said there is absolutely no risk of contracting herpes by receiving the Herpavac vaccine.

The Herpavac vaccine trial is a controlled study, with Hepatitis A vaccine being used as the control instead of a placebo.

Potential participants will first be screened for the presence of herpes simplex through a simple blood test.

"Some people may not realize they have had herpes before," said Peter F. Wright, M.D., professor of Pediatrics, Microbiology & Immunology, Pathology, and director of the division of Pediatric Infectious Diseases. "Typically 25 to 30 percent of potential participants screened for the study will already be positive for the virus."

Wright says the ultimate goal of the Herpavac study is to be able to protect women of child-bearing age from transmitting the herpes simplex virus to their offspring.

Genital herpes, while not considered a major health threat in adults, can in rare instances lead to further health complications. In individuals whose immune systems are suppressed, or who have other chronic illnesses, outbreaks of genital herpes can be severe. Frequently outbreaks can interfere with relationships. Regardless of other health complications, genital herpes commonly leads to psychological distress.

John Greene, M.D., director of the division of Young Adult Medicine, and the Zerfoss Student Health Center, has the not uncommon experience of diagnosing genital herpes among his patient population.

Greene and the staff of Vanderbilt’s Zerfoss Student Health Center will be assisting with recruitment for the trial.

"Unfortunately genital herpes is one of the most common sexually-transmitted infections on college and university campuses," Greene said. "While in some other patient populations, chlamydia, which can be treated with antibiotics, is more common, viral infections, including genital herpes, are more common on many campuses."

Greene says due to the current lack of a cure for genital herpes, patients are typically distraught when first diagnosed. He says there is usually some relief when they are told there are medications that usually help with symptom management.

"These medications suppress the virus and reduce the number of outbreaks, as well as the likelihood of transmission, but currently there is no cure," he said. "These facts make a herpes vaccine very desirable."

Wrights says Herpavac, made of a purified protein, has already undergone one extensive
U.S.
trial- which found it to be well tolerated, and also effective in preventing the transmission of the herpes simplex virus in women who have not been previously infected. Herpavac was found to be ineffective in women who were previously infected with herpes simplex virus, and was found to be completely ineffective in men.

"The only subgroup where the vaccine appeared to be truly effective is in women with no previous exposure to the virus," he said.

The ultimate goal for vaccine researchers is a herpes vaccine that could be distributed to women at an age when they first become sexually active.

Wright says VUMC’s participation in the herpes vaccine trial follows a continuing trend of the Medical Center’s involvement in vaccine trials for sexually-transmitted diseases that can also be transmitted to one’s offspring such as human papillomavirus (HPV), AIDS/HIV, and a forthcoming trial for cytomegalovirus (CMV). CMV can be transmitted sexually, or through other methods of close bodily contact such as blood, saliva, or breast milk, placing neonates at high risk for contracting the virus.

With 1500 women from 30 sites already enrolled in the national Herpavac study, VUMC is seeking 150 Nashville-area women to participate in the trial. Nationwide efforts seek enroll as many as 7,550 women.

VUMC’s trial participants will be followed at one of two separate vaccine monitoring sites; either on VUMC’s campus, or off campus near Centennial Hospital for those requiring easier parking. Participants will be required to return for eight additional monitoring visits over a 20-month period. Participants who should develop genital herpes through an infected partner during the course of the trial will require additional study.

For more information about the Herpavac trial- visit the NIH web site at www.herpesvaccine.nih.gov or contact Jana Wheeler at jana.wheeler@vanderbilt.edu or (615) 343-0784.

For More Information

Contact: John Howser, 615-322-4747

john.howser@vanderbilt.edu

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