Major herpes vaccine trial launched in women

November 20, 2002

A pivotal efficacy trial of an experimental vaccine designed to prevent genital herpes in women began enrolling volunteers this week. The study will determine the vaccine's ability to prevent genital herpes disease in women who are free of two common types of herpes simplex viruses (HSV): HSV-1 and HSV-2. The trial will eventually enroll 7,550 women in at least 16 sites in the United States. It is the result of a partnership between the National Institute of Allergy and Infectious Diseases (NIAID) and the vaccine's manufacturer, GlaxoSmithKline Biologicals (GSK), headquartered in Belgium.

"This vaccine trial is an excellent example of a mutually beneficial collaboration between the public and private sectors," says NIAID Director Anthony S. Fauci, M.D. "More than one million new cases of genital herpes are diagnosed in the United States each year. The physical and psychological toll taken by this sexually transmitted disease is considerable. Successful public-private collaborations such as this one will take us closer to our goal of reducing the spread of genital herpes."

Previous efficacy trials of the GSK vaccine were conducted in smaller numbers of men and women who did not have genital herpes but whose sexual partners were known to be infected. For reasons still not well understood, the vaccine prevented herpes disease in more than 70 percent of HSV-1 and HSV-2 negative women but had no clear effect in men. The results of these earlier Phase III trials are reported in this week's edition of The New England Journal of Medicine.

Finding thousands of HSV-negative women for the new trial will be a significant challenge, says Pamela McInnes, D.D.S, M.Sc.(Dent.), deputy director of NIAID's Division of Microbiology and Infectious Diseases. Between 50 and 80 percent of Americans are infected with HSV-1, typically during childhood, and about 1 in 5 people over age 12 is infected with HSV-2. The majority of those infected do not realize it, however, because symptoms of herpes disease can be mild or non-existent.

Symptoms following infection typically include blisters and then ulcers around the mouth or genitals. The virus may be transmitted through sexual or other skin-to-skin contact, and can even be spread when the infected person shows no symptoms. Once in the body, HSV migrates to nerve cells and remains there permanently. From time to time, an infected person may experience a herpes outbreak, but recurrences are typically less severe than the first occurrence. HSV can cause devastating illness in infants born to infected women, and the virus has been identified as a risk factor for the spread of HIV/AIDS in adults.

In the new trial, volunteers will be randomly assigned to receive either the candidate vaccine or a vaccine against hepatitis A. (This gives all participants a chance to be protected from a disease.) Neither the volunteers nor the researchers will know which vaccine a volunteer received until the close of the trial. Volunteers will be vaccinated at the start of the trial and at 1 and 6 months after the first injection. The women will be followed for 20 months after the initial vaccination to determine whether the candidate vaccine prevents HSV infection or disease. Robert B. Belshe, M.D., of NIAID's Vaccine Evaluation and Treatment Unit at the Saint Louis University School of Medicine, will co-ordinate the clinical investigation.

The GSK vaccine is a subunit vaccine containing a piece of the HSV outer coat along with adjuvants, which help boost the immune system for a better response. Women between the age of 18 and 30 who wish to be evaluated for possible inclusion in the trial should visit http://www.niaid.nih.gov/dmid/stds/herpevac/. Persons wishing to learn more about herpes can call the American Social Health Association at 919-361-8488. (Web site: http://www.ashastd.org).
-end-
NIAID is a component of the National Institutes of Health (NIH), which is an agency of the Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, illness from potential agents of bioterrorism, tuberculosis, malaria, autoimmune disorders, asthma and allergies.

Reference: LR Stanberry et al. Glycoprotein-D-adjuvant vaccine to prevent genital herpes. The New England Journal of Medicine 347:1652-61 (2002).

Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

NIH/National Institute of Allergy and Infectious Diseases

Related Infectious Diseases Articles from Brightsurf:

Understanding the spread of infectious diseases
Physicists at M√ľnster University (Germany) have shown in model simulations that the COVID-19 infection rates decrease significantly through social distancing.

Forecasting elections with a model of infectious diseases
Election forecasting is an innately challenging endeavor, with results that can be difficult to interpret and may leave many questions unanswered after close races unfold.

COVID-19 a reminder of the challenge of emerging infectious diseases
The emergence and rapid increase in cases of coronavirus disease 2019 (COVID-19), a respiratory illness caused by a novel coronavirus, pose complex challenges to the global public health, research and medical communities, write federal scientists from NIH's National Institute of Allergy and Infectious Diseases (NIAID) and from the Centers for Disease Control and Prevention (CDC).

Certain antidepressants could provide treatment for multiple infectious diseases
Some antidepressants could potentially be used to treat a wide range of diseases caused by bacteria living within cells, according to work by researchers in the Virginia Commonwealth University School of Medicine and collaborators at other institutions.

Opioid epidemic is increasing rates of some infectious diseases
The US faces a public health crisis as the opioid epidemic fuels growing rates of certain infectious diseases, including HIV/AIDS, hepatitis, heart infections, and skin and soft tissue infections.

Infectious diseases could be diagnosed with smartphones in sub-Saharan Africa
A new Imperial-led review has outlined how health workers could use existing phones to predict and curb the spread of infectious diseases.

The Lancet Infectious Diseases: Experts warn of a surge in vector-borne diseases as humanitarian crisis in Venezuela worsens
The ongoing humanitarian crisis in Venezuela is accelerating the re-emergence of vector-borne diseases such as malaria, Chagas disease, dengue, and Zika virus, and threatens to jeopardize public health gains in the country over the past two decades, warn leading public health experts.

Glow-in-the-dark paper as a rapid test for infectious diseases
Researchers from Eindhoven University of Technology (The Netherlands) and Keio University (Japan) present a practicable and reliable way to test for infectious diseases.

Math shows how human behavior spreads infectious diseases
Mathematics can help public health workers better understand and influence human behaviors that lead to the spread of infectious disease, according to a study from the University of Waterloo.

Many Americans say infectious and emerging diseases in other countries will threaten the US
An overwhelming majority of Americans (95%) think infectious and emerging diseases facing other countries will pose a 'major' or 'minor' threat to the U.S. in the next few years, but more than half (61%) say they are confident the federal government can prevent a major infectious disease outbreak in the US, according to a new national public opinion survey commissioned by Research!America and the American Society for Microbiology.

Read More: Infectious Diseases News and Infectious Diseases Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.