The University of Maryland School of Medicines Center for Vaccine Development (CVD) is participating in a nationwide study to test the effectiveness and safety of an experimental vaccine to prevent genital herpes in women.
The vaccine will be given to 7,500 sexually active women volunteers between the ages of 18 and 30. Half of the volunteers will receive the herpes vaccine in three separate doses over six months, and the other half of the volunteers will receive a vaccine for Hepatitis A. In this double blind study, neither the investigators nor the participants will know who received which vaccine until the study is over. All of the participants will be followed for a total of 20 months to measure the effectiveness of the herpes vaccine.
This vaccine has the potential to relieve a lot of physical discomfort and emotional distress, says Karen Kotloff, M.D., professor of pediatrics at the University of Maryland School of Medicine. Dr. Kotloff is the principal investigator for the Maryland arm of the study, which will be conducted at the CVDs College Park site. If proven effective, the vaccine would not only help prevent genital herpes disease in women, it might also substantially reduce the overall risk of infection for the entire population.
The vaccine contains a protein that is found on the surface of the herpes virus.
We believe the body sees this protein and makes antibodies that will protect people against the real herpes virus, explains Dr. Kotloff. In essence, the vaccine tricks the body into thinking that it has been exposed to the virus. If exposure to herpes occurs in the future, antibodies grab onto the virus and get rid of it. Unlike many vaccines, the herpes vaccine does not use a weakened form of a living virus, so there is no chance of contracting herpes or becoming ill from the vaccine.
Herpes is a common viral infection that is usually spread by skin-to-skin contact. Herpes is caused by two viruses, herpes simplex type one (HSV-1) and herpes simplex type two (HSV-2). HSV-1 typically causes cold sores or fever blisters on the mouth or face. An estimated 66 percent of the adult population has been exposed to HSV-1, according to the American Social Health Association, a national nonprofit organization dedicated to fighting sexually transmitted diseases through public education.
HSV-2 is responsible for causing most cases of genital herpes and is found in at least 22 percent of the U.S. population. Genital herpes causes a wide range of symptoms. These symptoms can be so mild that they go unrecognized, or they can include painful sores, blisters or flu-like symptoms.
Genital herpes can be transmitted through sexual contact even when there are no obvious symptoms. While herpes is considered a mild infection for adults, it can be a devastating illness for infants. A woman with active genital herpes at the time of delivery can pass the virus to a newborn.
In previous studies, the investigational vaccine resulted in a 74 percent reduction in genital herpes disease for women who had never been exposed to the virus. The vaccine did not protect men for reasons that are not understood. To be eligible for this study, women must test negative for both HSV-1 and HSV-2.
Because herpes is so common, finding women who qualify to participate in the trial has been a challenge, says Dr. Kotloff. That only underscores the need to find an effective vaccine.
Prospective study participants will be given a blood test to determine whether they have been exposed to herpes in the past. If they have, they will be given information on preventing the spread of the herpes virus and treatment. All participants will learn about how to reduce the risk of contracting or spreading herpes.
The study is funded and coordinated by the National Institute of Allergy and Infectious Diseases and GlaxoSmithKline Biologics. People interested in learning more can contact Pam Welch or Jane Cowan at (301) 314-7575.
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