Corporate Banner
Satellite Banner
Biologics & Bioprocessing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

NIH Launches Trial of Investigational Genital Herpes Vaccine

Published: Monday, November 11, 2013
Last Updated: Sunday, November 10, 2013
Bookmark and Share
Trial will test an investigational HSV-2 vaccine candidate, called HSV529.

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 United States. 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 United States 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, M.D.

Fauci continued, “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, M.D., 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, Ph.D., 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, M.D., 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 milliliters 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 one month and six months later. Participant safety will be monitored throughout the course of the trial, and researchers will follow participants for six 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.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Monkeys Protected by Zika DNA Vaccine
Experimental Zika virus DNA vaccines successfully protected monkeys against Zika infection.
Thursday, September 29, 2016
Mutations Linked to Immunotherapy Resistance
Researchers uncover mutations in tumors of three patients with advanced melanoma that allowed the tumors to become resistant to the immune checkpoint inhibitor pembrolizumab (Keytruda®).
Tuesday, August 09, 2016
Zika Vaccine Testing in Humans
The NAAID has initiated a clinical trail of a vaccine candidate for the prevention of the Zika virus infection.
Thursday, August 04, 2016
Zika Vaccine Candidates Show Promise
Two experimental vaccines have shown promise against a major viral strain responsible for the Brazilian Zika outbreak.
Friday, July 29, 2016
NIH Begins Yellow Fever Vaccine Trial
NIH has initiated an early-stage clinical trial of a vaccine to protect against yellow fever.
Thursday, July 28, 2016
Vaccine Strategy Targets Multiple Influenza Viruses
Scientists have identified vaccine-induced antibodies that can neutralize strains of influenza virus that infect humans.
Monday, July 25, 2016
NIH Investment Into HIV Research Expands
Funding has been awarded to six research teams to lead collaborative investigations worldwide toward an HIV cure.
Thursday, July 14, 2016
Large-scale HIV Vaccine Trial to Launch in South Africa
NIH-funded study will test safety, efficacy of vaccine regimen.
Wednesday, May 18, 2016
New HIV Vaccine Target Discovered
NIH-Led team have discovered a new vaccine target site on HIV.
Tuesday, May 17, 2016
Investigational Malaria Vaccine Protects Healthy U.S. Adults
Researchers at NIH have found that the malaria vaccine protected a small number of healthy, malaria-naïve adults in the U.S. from infection for more than one year after immunization.
Tuesday, May 10, 2016
Factors Influencing Influenza Vaccine Effectiveness Uncovered
The long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited, new research suggests.
Thursday, April 21, 2016
Study Finds Factors That May Influence Influenza Vaccine Effectiveness
Researchers at NIH have suggested that the long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited.
Wednesday, April 20, 2016
Improving Flu Vaccine Effectiveness
NIH study finds factors that may influence influenza vaccine effectiveness.
Wednesday, April 20, 2016
Submissions Open for the Cancer Moonshot Program
NCI opens online platform to submit ideas about research for Cancer Moonshot.
Tuesday, April 19, 2016
NIH Awards Grants to Explore Vaccine Adjuvants
NIH awards six grants to explore how combination adjuvants improve vaccines.
Wednesday, April 06, 2016
Scientific News
Mass Spec Technology Drives Innovation Across the Biopharma Workflow
With greater resolving power, analytical speed, and accuracy, new mass spectrometry technology and techniques are infiltrating the biopharmaceuticals workflow.
Monkeys Protected by Zika DNA Vaccine
Experimental Zika virus DNA vaccines successfully protected monkeys against Zika infection.
New Weapon Against Hard-to-Treat Bacterial Infections
Using peptides, researchers have been able to prevent drug-resistance bacteria from forming abscesses.
Tapping Evolution to Improve Biotech Products
Researchers show how 'ancestral sequence reconstruction' can be used to guide engineering of a blood clotting protein.
Antibodies Paving the Way to HIV Vaccine
Researchers uncover factors responsible for the formation of broadly neutralizing HIV antibodies in humans.
Vaccine Against Common Cold Achievable
Researchers suggest that a vaccine against rhinoviruses is possible using variant virus vaccines.
Treating Sepsis with Marine Mitochondria
Mitochondrial alternative oxidase from a marine animal combats bacterial sepsis.
Biomolecular Manufacturing ‘On-the-Go’
Wyss Institute team unveils a low-cost, portable method to manufacture biomolecules for a wide range of vaccines, other therapies as well as diagnostics.
Molecular Switch Aids Immune Therapy
Researchers identify strategy to maximise effectiveness of immune therapy through molecular switch controlling immune suppression.
GSK’s Shingles Vaccine Candidate Shows High Efficacy
The vaccine candidate showed high efficacy against shingles and its complications in adults aged 70yrs+ in phase III study.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!