Navigation Links
NEJM publishes study showing LigoCyte's norovirus vaccine demonstrates protection against illness
Date:12/7/2011

BOZEMAN, Mont., Dec. 7, 2011 LigoCyte Pharmaceuticals, Inc. announced today that its experimental vaccine provided significant protection against norovirus infection and related gastrointestinal illness collectively known as acute gastroenteritis (AGE). Norovirus infection, sometimes referred to as "the stomach flu" is one of the most common causes of severe nausea, vomiting, abdominal cramps and diarrhea afflicting 21 million Americans annually and is an important contributor to gastrointestinal disease worldwide. This was the first time a vaccine has demonstrated protection against norovirus. No commercially available vaccines or specific therapies currently exist to prevent or treat norovirus infection. The results of the Phase I/II study, conducted with a virus-like particle (VLP) vaccine, were published today in The New England Journal of Medicine. This study was a multi-center trial performed in collaboration with a consortium including Baylor College of Medicine, Cincinnati Children's Hospital, Johns Hopkins University, SNBL CPC, Inc., University of Maryland and The EMMES Corporation.

"This is the first demonstration of protection in humans against what is a widespread and often serious illness and is a big development for the field," said Robert Atmar, M.D., of Baylor College of Medicine and the study's principal investigator. "The number of hospitalizations and the healthcare costs associated with norovirus are staggering; a successful vaccine against norovirus would offer significant protection to patients as well as potential cost reductions for the healthcare system."

"The positive results from this rigorous challenge study demonstrate that norovirus gastroenteritis, which can result in severe illness in many people, can be prevented by vaccination," said Donald P. Beeman, LigoCyte's Chief Executive Officer. "Development of our bivalent intramuscular vaccine is currently underway, and we look forward to the results of upcoming clinical studies of the product."

Specifically, data from the study show:

  • In the 77 adults who completed the trial per its original protocol, vaccination decreased the incidence of gastroenteritis due to norovirus from 69.2 percent to 36.8 percent, a 47 percent reduction in illness compared to subjects receiving placebo (95% CI 15.2%-66.6%; p=.006).

  • Subjects receiving vaccine scored lower on a severity of illness scale (p=.011).

  • Immunization with the VLP vaccine increased antibody titers that blocked VLP binding to histo blood group antigens in vitro.

  • Higher functional antibody responses in all subjects correlated with increased protection against illness. A serum BT50 titer of 200 or greater was associated with a 72.2 percent reduction in virus-associated illness (odds ratio of 8.1 (95% CI 2.1-31.2)).

  • Adverse events occurred with similar frequency among vaccine and placebo subjects. The most common symptoms after vaccination included nasal congestion, stuffiness and sneezing.

About Norovirus Illness

Norovirus gastroenteritis is a widespread and potentially severe illness characterized by the acute onset of nausea, vomiting, abdominal cramps, diarrhea and occasionally fever. Noroviruses are highly infective and easily transmitted from person to person or via contaminated environments. Epidemic outbreaks occur in community environments, particularly hospitals, hotels, schools, day care facilities and nursing homes, with mounting socioeconomic cost to families, the health care system and businesses. Military units are significantly affected when the virus strikes, as outbreaks impact combat readiness. Severe clinical outcomes are reported in older adults, children and immunocompromised individuals in whom infection can lead to substantial complications and can even lead to death.

About the Phase I/II Norovirus Vaccine and Challenge Study

The Phase I/II randomized, double blind, multi-center, placebo-controlled safety and efficacy study was designed to evaluate the norovirus monovalent GI.1 VLP vaccine versus placebo in approximately 90 healthy adult volunteers between the ages of 18 and 50 years. The study consisted of two stages: the vaccination stage with post-vaccination follow-up, followed by the challenge stage, in which subjects were exposed to the live virus, with post-challenge follow-up. Subjects received a two-dose intranasal regimen of either the vaccine or placebo on days 0 and 21 and were evaluated for vaccine safety and immune responses. On or after study day 42, subjects were admitted to an inpatient nursing unit, challenged with live norovirus, held in the unit for at least four days following challenge and then followed for post-challenge safety and efficacy with multiple clinical assessments and collection of stool specimens. The study was conducted at Baylor College of Medicine, the University of Cincinnati and Cincinnati Children's Hospital Medical Center, the Johns Hopkins School of Medicine and SNBL CPC, Inc., a clinical research organization in Baltimore, Md.

About LigoCyte's Intranasal Norovirus Vaccine Candidate

LigoCyte's intranasal norovirus vaccine is a dry powder formulation containing virus-like particle (VLP) antigens representing the live virus while lacking the ability to reproduce or cause illness. VLPs mimic the natural virus by preserving the authentic structure of the viral capsid, the shell of protein that protects the nucleic acid of a virus. LigoCyte's vaccine formulation also includes the adjuvant Monophosphoryl Lipid A, provided under license from GlaxoSmithKline PLC (NYSE: GSK), and the nasal vaccine incorporates chitosan. This application of chitosan (ChiSys) has been licensed from Archimedes Development Ltd.(1)

A clinical study of an intramuscular bivalent formulation of LigoCyte's norovirus vaccine is ongoing. Preliminary results from that study were presented by one of the principal investigators in the study, Sharon Frey, M.D., from the Saint Louis University Center for Vaccine Development at the Saint Louis University School of Medicine, at the Infectious Diseases Society of America (IDSA) 2011 Annual Meeting on October 21 in Boston, Mass. Data presented at the meeting indicate that the intramuscular vaccine induces immune responses that are even more potent than the nasal formulation of the vaccine.


'/>"/>

Contact: Kari Watson
kwatson@macbiocom.com
781-235-3060
MacDougall Biomedical Communications, Inc.
Source:Eurekalert

Related medicine news :

1. Canadian Journal of Cardiology publishes report on delayed vs. immediate coronary stenting
2. European Journal of Heart Failure publishes new randomized controlled clinical study of RESPeRATE
3. ASTRO publishes white paper on IMRT safety
4. EMAS publishes position statement about the post-reproductive health of women
5. ASTRO publishes evidence-based guideline for thoracic radiotherapy
6. Canadian Journal of Cardiology publishes advice on genetic testing of inherited cardiac arrhythmias
7. NYSCF - Robertson investigator publishes research to better understand pluripotent stem cells
8. ASTRO publishes palliative radiotherapy for bone metastases guideline
9. Practical Radiation Oncology publishes first issue
10. EMAS publishes position statements about the post-reproductive health of women
11. ASTRO publishes whole breast irradiation guidelines
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2017)... ... May 26, 2017 , ... Rob Lowe acts as ... production of the series is on hiking in American. Viewers can reconnect with America ... great benefits of hiking. , Many consumers have looked for an inventive new place ...
(Date:5/26/2017)... ... May 26, 2017 , ... “THE FLINTHILLS FAMILY-Our Journey to the Cross”: the personal journey of ... Cross” is the creation of published authors, Bob and Margaret Massey. Bob Massey is ... is "panther quick and leather tough." His love for others is apparent in all ...
(Date:5/26/2017)... ... ... Jack: Against All Odds”: the story of Coach Cactus Jack and the impact he ... creation of published author, Walter Hubbard, a retired wildlife and fisheries biologist and pharmacy ... Walter and Jane have three adult children and a granddaughter. Walter and ...
(Date:5/24/2017)... ... May 24, 2017 , ... In ... choosing the most appropriate instruments for research and understanding the basic principles that ... webinar will focus on innovations in stereo microscopy for brightfield and fluorescence typically ...
(Date:5/24/2017)... California (PRWEB) , ... May 24, 2017 , ... ... through innovative medical image management and interpretation, has received U.S. Food and Drug ... , Nucleus.io is a web-based, scalable and secure cloud platform for medical image ...
Breaking Medicine News(10 mins):
(Date:5/15/2017)... Inc., a privately-held CNS pharmaceutical company based in ... disease (PD), has enrolled the first patient in the RASMET ... study involving patients with PD and taking place at 12 ... period. The first stage is open label and involves single ... Denver , Boca Raton ...
(Date:5/10/2017)... Global Health Intelligence (GHI), the leading healthcare data analytics ... 2017 ranking of the Best-Equipped Hospitals in Latin America ... GHI,s hospitals database for Latin America , which is ... database covers 86% of the hospitals in Latin ... each institution in key areas such as beds, medical specialties, ...
(Date:5/9/2017)... -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), ... has earned a spot on Forbes, "America,s ... ranked among 500 U.S. employers as well as in ... Services. The annual Forbes rankings ... of over 30,000 employees across 25 industries. The survey ...
Breaking Medicine Technology: