Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
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
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 2,500+ scientific posters on ePosters
  • More than 3,700+ 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

Young South African Women can Adhere to Daily PrEP Regimen as HIV Prevention
NIH-funded study finds men in Bangkok, Harlem also successful in taking daily dose.
Saturday, July 25, 2015
Study Shows Promise of Precision Medicine for Most Common Type of Lymphoma
The study appeared online July 20, 2015, in Nature Medicine.
Tuesday, July 21, 2015
HIV Control Through Treatment Durably Prevents Heterosexual Transmission of Virus
NIH-funded trial proves suppressive antiretroviral therapy for HIV-infected people effective in protecting uninfected partners.
Tuesday, July 21, 2015
Early Antiretroviral Therapy Prevents Non-AIDS Outcomes in HIV-infected People
NIH-supported findings illustrate manifold benefit of therapy.
Tuesday, July 21, 2015
NIH-funded Vaccine for West Nile Virus Enters Human Clinical Trials
Enrollment is expected to be completed by December 2015.
Tuesday, July 07, 2015
In Blinding Eye Disease, Trash-Collecting Cells Go Awry, Accelerate Damage
NIH research points to microglia as potential therapeutic target in retinitis pigmentosa.
Friday, July 03, 2015
Boys More Likely to Have Antipsychotics Prescribed, Regardless of Age
NIH-funded study is the first look at antipsychotic prescriptions patterns in the U.S.
Thursday, July 02, 2015
New Medication for Alcohol Use Disorder
NIH begins clinical trial investigating a potential treatment for alcohol use disorder.
Friday, June 26, 2015
NIH Begins Clinical Trial of New Medication for Alcohol Use Disorder
Clinical trial will evaluate the safety and effectiveness of gabapentin enacarbil in treating alcohol use disorder.
Friday, June 26, 2015
Study of Ebola Survivors Opens in Liberia
Trial to examine long-term health effects of Ebola virus disease.
Friday, June 19, 2015
NIH Names Walter J. Koroshetz, M.D. Director of the NINDS
Dr. Collins recognized Dr. Koroshetz’ role in the creation of the StrokeNet.
Saturday, June 13, 2015
NCI-MATCH Trial will Link Targeted Cancer Drugs to Gene Abnormalities
Precision medicine trial will open to patient enrollment in July.
Tuesday, June 09, 2015
Linking Targeted Cancer Drugs to Gene Abnormalities
Investigators at the NIH have announced a series of clinical trials that will study drugs or drug combinations that target specific genetic mutations.
Wednesday, June 03, 2015
Starting Antiretroviral Treatment Early Improves Outcomes for HIV-infected Individuals
NIH-funded trial results likely will impact global treatment guidelines.
Thursday, May 28, 2015
Two Treatments Yield Similar Results for Children After Cardiac Arrest
NIH-funded research finds therapeutic hypothermia no more effective than normal temperature control.
Friday, May 08, 2015
Scientific News
Liquid Biopsies: Utilization of Circulating Biomarkers for Minimally Invasive Diagnostics Development
Market Trends in Biofluid-based Liquid Biopsies: Deploying Circulating Biomarkers in the Clinic. Enal Razvi, Ph.D., Managing Director, Select Biosciences, Inc.
Study Questions Presence in Blood of Heart-Healthy Molecules from Fish Oil Supplements
A new study from the Perelman School of Medicine at the University of Pennsylvania questions the relevance of fish oil-derived SPMs and their purported anti-inflammatory effects in humans.
Experimental MERS Vaccine Shows Promise in Animal Studies
A two-step regimen of experimental vaccines against Middle East respiratory syndrome (MERS) prompted immune responses in mice and rhesus macaques, report National Institutes of Health scientists who designed the vaccines.
Young South African Women can Adhere to Daily PrEP Regimen as HIV Prevention
NIH-funded study finds men in Bangkok, Harlem also successful in taking daily dose.
Key Player in Diabetic Kidney Disease Revealed
Discovery could lead to new and better diagnostic marker for chronic kidney disease.
Immunotherapy Shows Promise for Myeloma
A strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
Santhera Announces First Patient Dosing with Omigapil in CMD
Company announces full patient recruitment of CALLISTO study.
Study Shows Promise of Precision Medicine for Most Common Type of Lymphoma
The study appeared online July 20, 2015, in Nature Medicine.
HIV Control Through Treatment Durably Prevents Heterosexual Transmission of Virus
NIH-funded trial proves suppressive antiretroviral therapy for HIV-infected people effective in protecting uninfected partners.
Adaptimmune's Novel Cancer Therapeutics Show Positive Clinical Trial Results
The company has announced that positive data from its Phase I/II study of its affinity enhanced T-cell receptor (TCR) therapeutic targeting the NY-ESO-1 cancer antigen in patients with multiple myeloma has been published.
Scroll Up
Scroll Down
SELECTBIO

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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!