FEB2013

PHASE 1 Safety and Immunogenicity of Two Live, Attenuated Oral Shigella Sonnei Vaccines WRSs2 and WRSs3

Phase 1, randomized, double-blind, placebo controlled, dose-escalation, inpatient study of single doses of S. sonnei. Enroll serial groups up to 90 subjects. Evaluate safety and tolerance of WRSs2 by monitoring presence and severity of clinical signs and symptoms, evaluate the immune response in blood and stool following ingestion of WRSs2

http://clinicaltrials.gov/show/NCT01336699

Shigellosis is one of those nasty bacterial diseases that follows the cringeworthy fecal-oral route to infect humans and other primates. Mild cases bring stomachaches; the severe end includes cramping, vomiting, fever, diarrhea, and it generally only gets more disgusting from there. While the disease can occur all over the world—estimates suggest ninety million cases of Shigellosis dysentery each year—the greatest mortality occurs in the third world. Hoping to stem transmission, or, at least, minimize the damage it causes, the World Health Organization has long called for a vaccine to stop Shigella infection.

And, today, scientists are one step closer. The National Institutes of Health announced that two Shigella vaccine have entered early-stage human clinical trials:

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 1 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.

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 ….

…. 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.