NIH Launches Trial of Investigational Genital Herpes Vaccine

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 of Health, is sponsoring the Phase I trial, which is being conducted at the NIH Clinical Center in Bethesda, Md.
Genital herpes is one of the most common sexually transmitted infections in the US. Most genital herpes cases are caused by infection with herpes simplex virus type 2 (HSV-2); however, herpes simplex virus type 1 (HSV-1) can also cause genital herpes. An estimated 776,000 people in the US are infected with HSV-2 or HSV-1 each year. There is no vaccine to prevent genital herpes.
“Although genital herpes is treatable, it is a lifelong infection that can exact a substantial psychological and physical toll on infected individuals and places them at higher risk of acquiring HIV,” said NIAID Director Anthony S. Fauci, MD. “Furthermore, mothers with active genital herpes infection at time of delivery can transmit the virus to their newborns, which can lead to severe illness and death.”
“A protective vaccine would help to reduce significantly the spread of this all-too-common sexually transmitted infection,” Fauci added.
Led by principal investigator Lesia K. Dropulic, MD, of NIAID’s Laboratory of Infectious Diseases, the trial will test an investigational HSV-2 vaccine candidate, called HSV529, for safety and the ability to generate an immune system response. The investigational vaccine manufactured by Sanofi Pasteur was developed by David Knipe, PhD, professor of microbiology and immunobiology at Harvard Medical School, Boston.
Preclinical testing of the candidate vaccine involved a 10-year collaborative effort between Dr Knipe and Jeffrey Cohen, MD, chief of NIAID’s Laboratory of Infectious Diseases. The experimental product is a replication-defective vaccine, meaning that scientists have removed two key proteins from the vaccine virus so that it cannot multiply to cause genital herpes.
The clinical trial is expected to enroll 60 adults ages 18 to 40, who will be divided into three groups of 20 participants each. The first group will be of people who have been previously infected with HSV-2 and HSV-1 or solely with HSV-2; the second will have individuals who had been infected with HSV-1 only; and the third will consist of those who have not been infected with HSV-1 or HSV-2. The investigational vaccine is being tested among study participants who have previously been infected with HSV to determine if it may pose any safety issues.
Within each of the three groups, researchers will randomly assign participants to receive three doses (0.5 mL each) of the investigational HSV529 vaccine (15 participants) or a saline-based placebo vaccine (five participants). The three vaccinations will occur at study enrollment and again 1 month and 6 months later. Participant safety will be monitored throughout the course of the trial, and researchers will follow participants for 6 months after they have received their last dose of vaccine. Blood samples will be used to evaluate the candidate vaccine’s ability to stimulate immune system responses to HSV-2, including production of virus-specific antibodies and T-cell responses. The study is expected to be completed by October 2016.
HSV-2 is generally transmitted through sexual contact and can spread even when the infected individual shows no symptoms. Although HSV-1 commonly infects the mouth and lips, it can also cause genital herpes. Once in the body, HSV migrates to nerve cells and remains there permanently, where it can reactivate to cause painful sores and blisters.
Related News
-
News Google-backed start-up raises US$600 million to support AI drug discovery and design
London-based Isomorphic Labs, an AI-driven drug design and development start-up backed by Google’s AI research lab DeepMind, has raised US$600 million in its first external funding round by Thrive Capital. The funding will provide further power t... -
News AstraZeneca to invest US$2.5 billion in Beijing R&D centre
Amid investigations of former AstraZeneca China head Leon Wang in 2024, AstraZeneca have outlined plans to establish its sixth global strategic R&D centre in China. Their aim is to further advance life sciences in China with major research and manufact... -
News Experimental drug for managing aortic valve stenosis shows promise
The new small molecule drug ataciguat is garnering attention for its potential to manage aortic valve stenosis, which may prevent the need for surgery and significantly improve patient experience. -
News How GLP-1 agonists are reshaping drug delivery innovations
GLP-1 agonist drug products like Ozempic, Wegovy, and Mounjaro have taken the healthcare industry by storm in recent years. Originally conceived as treatment for Type 2 diabetes, the weight-loss effects of these products have taken on unprecedented int... -
News A Day in the Life of a Start-Up Founder and CEO
At CPHI we work to support Start-Up companies in the pharmaceutical industry and recognise the expertise and innovative angles they bring to the field. Through our Start-Up Programme we have gotten to know some of these leaders, and in this Day in the ... -
News Biopharmaceutical manufacturing boost part of new UK government budget
In their national budget announced by the UK Labour Party, biopharmaceutical production and manufacturing are set to receive a significant boost in capital grants through the Life Sciences Innovative Manufacturing Fund (LSIMF). -
News CPHI Podcast Series: The power of proteins in antibody drug development
In the latest episode of the CPHI Podcast Series, Lucy Chard is joined by Thomas Cornell from Abzena to discuss protein engineering for drug design and development. -
News Amgen sues Samsung biologics unit over biosimilar for bone disease
Samsung Bioepis, the biologics unit of Samsung, has been issued a lawsuit brought forth by Amgen over proposed biosimilars of Amgen’s bone drugs Prolia and Xgeva.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance