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Targeting HSV

Article / Review by on November 8, 2013 – 7:44 pmNo Comments

Targeting HSV
NIH launches trial of genital herpes vaccine

An experimental genital herpes vaccine developed by Harvard Medical School researchers is being tested in an early-stage clinical trial conducted by a branch of the National Institutes of Health.

There is currently no vaccine to prevent genital herpes disease, a sexually transmitted infection caused by herpes simplex virus 1 (HSV-1) or 2 (HSV-2). Outbreaks of painful sores and blisters, which can be treated but not cured, alternate with silent periods when the virus retreats into neurons where it lies dormant until reactivated. HSV-1 commonly infects the mouth and lips, but it can also cause genital herpes.

David Knipe, HMS Higgins Professor of Microbiology and Molecular Genetics, led development of an experimental genital herpes vaccine now in clinical trials. Image: Knipe Lab

David Knipe, HMS Higgins Professor of Microbiology and Molecular Genetics, led development of an experimental genital herpes vaccine now in clinical trials. Image: Knipe Lab

About three-quarters of a million people are newly infected with genital herpes each year in the United States, causing suffering in adults and threatening the lives of infants born to infected women. HSV-1 can also cause blindness if recurrent infections spread to the cornea. If either HSV-1 or HSV-2 enters the central nervous system, it can lead to encephalitis.

In sub-Saharan Africa, where risk for HIV infection is high, as many as 80 percent of the population is infected with HSV-2.

“There’s a medical need to prevent herpes disease, but the biggest issue is that genital herpes increases the risk of HIV infection,” said David Knipe, HMS Higgins Professor of Microbiology and Molecular Genetics. “A genital herpes vaccine that prevented HSV-2 infection could reduce the risk of HIV infection.”

Creating a safe, effective vaccine has been difficult for scientists around the globe, mirroring the long parallel road toward an HIV vaccine.  While some HSV vaccine candidates studied in animals have prompted the immune system to form antibodies to HSV, they couldn’t induce a T cell response that would also kill cells infected with the virus. Both lines of defense are needed, Knipe said. Other vaccine candidates that effectively mounted a dual immune response failed safety tests.

It was 20 years ago that Knipe took the first, indirect steps toward the experimental vaccine.  While studying gene function in viruses, Knipe and his colleagues had genetically altered the virus so it could not make copies of itself.  The mutant version of the virus enters cells, prompting both an antibody and T cell response, but it can’t multiply.

At the time, this approach ran counter to the dogma stating that viral vaccines must contain killed virus or weakened viral components to stimulate a durable immune response. Since then, these “replication-defective” viruses have been enlisted as smallpox vaccines and vectors for investigational HIV vaccines.

The current clinical trial, led by Lesia Dropulic of the National Institute of Allergy and Infectious Diseases, is testing an HSV-2 vaccine candidate manufactured by Sanofi Pasteur. Knipe is a consultant for Sanofi but he is not involved in the trial.

The NIAID researchers hope to enroll 60 adults, age 18 to 40, who will be divided into three groups: people who have previously been infected with HSV-1 and HSV-2 or only HSV-2; people who have previously been infected only with HSV-1; and people who have not been infected with either HSV-1 or HSV-2. Participants will be randomly chosen to receive three doses of the experimental vaccine or a placebo. Their safety will be monitored and their blood will be drawn to evaluate the vaccine’s ability to stimulate an immune system response to HSV-2.

The study is expected to conclude in October 2016.

“Although genital herpes is treatable, it is a lifelong infection that exacts a tremendous psychological and physical toll on the infected individual,” NIAID Director Anthony S. Fauci said in a statement announcing the clinical trial. “A protective vaccine would help to significantly reduce the spread of this all-too-common sexually transmitted infection.”



About Harvard Medical School (HMS)

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“Since 1872, Harvard Medical School has been the incubator of bold ideas—a place where extraordinary people advance education, science and health care with unrelenting passion.

Whether training tomorrow’s doctors and scientists, decoding the fundamental nature of life, advancing patient care or improving health delivery systems around the world, we are never at rest. Allied with some of the world’s best hospitals, research institutes and a University synonymous with excellence, the School’s mission remains as ambitious as it is honorable: to alleviate human suffering caused by disease.”

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About Harvard School of Public Health (HSPH)

Harvard School of Public Health is dedicated to advancing the public’s health through learning, discovery and communication. More than 400 faculty members are engaged in teaching and training the 1,000-plus student body in a broad spectrum of disciplines crucial to the health and well being of individuals and populations around the world. Programs and projects range from the molecular biology of AIDS vaccines to the epidemiology of cancer; from risk analysis to violence prevention; from maternal and children’s health to quality of care measurement; from health care management to international health and human rights.

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About Harvard University.

Established in 1636, Harvard is the oldest institution of higher education in the United States. The University, which is based in Cambridge and Boston, Massachusetts, has an enrollment of over 20,000 degree candidates, including undergraduate, graduate, and professional students. Harvard has more than 360,000 alumni around the world.

Harvard University is devoted to excellence in teaching, learning, and research, and to developing leaders in many disciplines who make a difference globally. Harvard faculty are engaged with teaching and research to push the boundaries of human knowledge. For students who are excited to investigate the biggest issues of the 21st century, Harvard offers an unparalleled student experience and a generous financial aid program, with over $160 million awarded to more than 60% of our undergraduate students. The University has twelve degree-granting Schools in addition to the Radcliffe Institute for Advanced Study, offering a truly global education.

‘Universities nurture the hopes of the world: in solving challenges that cross borders; in unlocking and harnessing new knowledge; in building cultural and political understanding; and in modeling environments that promote dialogue and debate… The ideal and breadth of liberal education that embraces the humanities and arts as well as the social and natural sciences is at the core of Harvard’s philosophy. ’/ Drew Gilpin Faust

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* The above story is adapted from materials provided by Harvard University

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