Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

NIH-funded Researchers Begin Trial of Shigella Vaccine Candidates

Published: Friday, February 22, 2013
Last Updated: Friday, February 22, 2013
Bookmark and Share
Aim to thwart a principal cause of diarrheal disease worldwide.

Researchers have launched an early-stage human clinical trial of two related candidate vaccines to prevent infection with Shigella, bacteria that are a significant cause of diarrheal illness, particularly among children.

The Phase I clinical trial, funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will evaluate the vaccines for safety and their ability to induce immune responses among 90 healthy adults ages 18 to 45 years.

The trial is being conducted at the Cincinnati Children’s Hospital Medical Center, one of the eight NIAID-funded Vaccine and Treatment Evaluation Units in the United States.

Shigella infection, called shigellosis, is an intestinal disease spread via contact with infected feces, by consumption of contaminated food or water or by contact with a contaminated surface.

Symptoms include diarrhea, abdominal pain, fever, nausea and vomiting. In healthy adults, the infection generally clears on its own in five to seven days, but if left untreated, can lead to hospitalization or death, especially among young children and adults with weakened immune systems.

According to the World Health Organization, shigellosis causes roughly 90 million cases of severe disease each year and 108,000 deaths, most of which occur in the developing world and affect children under 5 years of age.

In the United States, 14,000 shigellosis cases are reported annually, with most cases occurring among children ages 1 to 4 years.

Antibiotics are the standard treatment for patients with shigellosis, but drug-resistant strains of the bacterium are becoming more common.

“It seems that Shigella bacteria know our immune system better than we do,” said William Alexander, Ph.D., a program officer in NIAID’s Enteric and Hepatic Diseases Branch, Division of Microbiology and Infectious Diseases.

Alexander continued, “They’ve become very good at evading the human immune response and causing significant illness, so developing vaccines and better treatments is critical.”

Led by principal investigator Robert W. Frenck, Jr., M.D., director of clinical medicine at Cincinnati Children’s, the new clinical trial will evaluate two related candidate vaccines, known as WRSs2 and WRSs3, which have been found to be safe and effective when tested in guinea pigs and nonhuman primates.

Both target Shigella sonnei, one of the bacteria’s four subtypes and the cause of most shigellosis outbreaks in developed and newly industrialized countries.

Though neither candidate vaccine has been tested in humans, a precursor to both, known as WRSs1, was found to be safe and generated an immune response in small human trials in the United States and Israel.

This early work was supported by NIAID, the U.S. Department of Defense and the Walter Reed Army Institute of Research. All three versions of the vaccine were developed by researchers at the Walter Reed institute.

WRSs2 and WRSs3 are live, attenuated vaccines, which means that the bacteria they contain are weakened such that they do not cause illness but still can induce an immune response.

The weakened versions of S. sonnei used in WRSs2 and WRSs3 cannot spread between human cells, limiting their ability to cause disease.

They are designed to improve upon WRSs1 by reducing the mild diarrhea associated with that vaccine in some patients. In addition, WRSs3 is designed to reduce the fever that accompanied some WRSs1 vaccinations.

After undergoing informed consent, study participants will be split into 10 groups of eight participants each, with each group receiving an increasing dose of WRSs2 or WRSs3. The remaining 10 participants will receive placebo.

All doses will be given orally and will be preceded with a sodium bicarbonate (baking soda) suspension to neutralize stomach acid, which prevents the bacteria in the vaccine from being killed too quickly.

Immediately after vaccination, participants will be admitted to inpatient care. Eight days later, or sooner if serious shigellosis symptoms occur, participants will begin a course of antibiotics until they pass two consecutive stools that test negative for S. sonnei. During the hospital stay, which can last up to 13 days, participants will be closely monitored and receive physical exams several times daily.

Once discharged, participants are expected to collect and supply a stool sample at follow-up physical exams on study days 14, 28 and 56.


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 3,200+ scientific posters on ePosters
  • More Than 4,600+ 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

Manufactured Stem Cells to Advance Clinical Research
Clinical-grade cell line will enable development of new therapies and accelerate early-stage clinical research.
Saturday, June 25, 2016
Rates of Nonmedical Prescription Opioid Use Disorder Double in 10 Years
Researchers at NIH have found that the nonmedical use of prescription opioids has more than doubled among adults in the United States from 2001-2002 to 2012-2013.
Thursday, June 23, 2016
Peanut Allergy Prevention Strategy is Nutritionally Safe
Early-life peanut consumption does not affect duration of breastfeeding or children’s growth and nutrition.
Wednesday, June 22, 2016
NIH Launches Large Study of Pregnant Women in Areas Affected by Zika virus
Researchers at NIH and Fiocruz have begun a study to evaluate the magnitude of health risks that Zika virus infection poses to pregnant women and their developing fetuses and infants.
Wednesday, June 22, 2016
New Imaging Method May Predict Risk of Post-Treatment Brain Bleeding After Stroke
Researchers at NIH have developed technique that provides new insight into stroke.
Tuesday, June 21, 2016
Study Reveals Central Role of Endocannabinoids in Habit Formation
The new study findings point to a previously unknown mechanism in the brain that regulates the transition between goal-directed and habitual behaviors.
Tuesday, June 21, 2016
Predicting Effective Drug Combinations For TB
Researchers analyzed gene regulatory networks to explain the effectiveness of an experimental drug combination against drug-resistant tuberculosis bacteria.
Wednesday, June 15, 2016
Genomic Data Commons Launched
Part of the National Cancer Moonshot, the GDC will centralize and standardize accessible data.
Tuesday, June 07, 2016
Prevention May be Essential to Reducing Racial Disparities in Stroke
Researchers at NIH have found study provides clues to differences in stroke deaths between blacks and whites.
Friday, June 03, 2016
NIH Funds Biobank To Support Precision Medicine Initiative Cohort Program
$142 million over five years will be awarded to the Mayo Clinic to establish the world’s largest research-cohort biobank for the PMI Cohort Program
Friday, May 27, 2016
Advancing Protein Visualization
Cryo-EM methods can determine structures of small proteins bound to potential drug candidates.
Friday, May 27, 2016
New NIH-EPA Research Centers to Study Environmental Health Disparities
Scientists will partner with community organizations to study these concerns and develop culturally appropriate ways to reduce exposure to harmful environmental conditions.
Thursday, May 26, 2016
Nanoparticles Target, Transform Fat Tissue
Nanoparticles designed to target white fat and convert it to calorie-burning brown fat slowed weight gain in obese mice without affecting food intake. This proof-of-concept work could lead to new therapies to treat obesity.
Wednesday, May 25, 2016
Visual Impairment, Blindness Cases in U.S. Expected to Double by 2050
Researchers at NIH have suggested that there is a need for increased screening and interventions to identify and address treatable causes of vision loss.
Friday, May 20, 2016
Drug Might Help Treat Sepsis
A DNA enzyme called Top1 plays a key role in turning on genes that cause inflammation in mouse and human cells in response to pathogens. A drug blocking this enzyme rescued mice from lethal inflammatory responses, suggesting a potential treatment for sepsis.
Wednesday, May 18, 2016
Scientific News
Platelets are the Pathfinders for Leukocyte Extravasation During Inflammation
Findings from the study could help in the prevention and treatment of inflammatory pathologies.
ASMS 2016: Targeting Mass Spectrometry Tools for the Masses
The expanding application range of MS in life sciences, food, energy, and health sciences research was highlighted at this year's ASMS meeting in San Antonio, Texas.
Benchtop Automation Trends
Gain a better understanding of current interest in and future deployment of benchtop automated systems.
Manufactured Stem Cells to Advance Clinical Research
Clinical-grade cell line will enable development of new therapies and accelerate early-stage clinical research.
Dengue Virus Exposure May Amplify Zika Infection
Researchers at Imperial College London have found that the previous exposure to the dengue virus may increase the potency of Zika infection.
Gender Determination in Forensic Investigations
This study investigated the effectiveness of lip print analysis as a tool in gender determination.
Identifying Novel Types of Forensic Markers in Degraded DNA
Scientists have tried to verify the nucleosome protection hypothesis by discovering STRs within nucleosome core regions, using whole genome sequencing.
Proteins in Blood of Heart Disease Patients May Predict Adverse Events
Nine-protein test shown superior to conventional assessments of risk.
Higher Frequency of Huntington's Disease Mutations Discovered
University of Aberdeen study shows that the gene change that causes Huntington's disease is much more common than previously thought.
Starving Stem Cells May Enable Scientists To Build Better Blood Vessels
Researchers from the University of Illinois at Chicago College of Medicine have uncovered how changes in metabolism of human embryonic stem cells help coax them to mature into specific cell types — and may improve their function in engineered organs or tissues.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
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
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,600+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!