Vaccine developer GlycoVaxyn AG announced positive data from the Phase I clinical study on its Shigella dysentariae bioconjugate vaccine. According to the company the results from the study show that the vaccine demonstrated safety and good immune response.
The study conducted at the Institute for Social and Preventive Medicine of the University of Zürich, Switzerland, under the supervision of principal investigators Professors Hatz and Steffen.
In the study, 40 healthy volunteers were assessed for antibody response and safety to the vaccine candidate. Subjects of both genders were randomly given vaccine in ascending antigen dose with and without adjuvant. The vaccines were given in two doses, 60 days apart.
As far as the issue of safety, no significant adverse reactions were noted among all volunteers.
The vast majority achieved excellent antibody response with 80% achieving a four-fold increase in antibody level as compared to their own pre-vaccination levels. Both antibodies IgG and IgA were elicited in all vaccine dose levels.
Shigellosis is an acute bacterial disease of the intestines caused by several species of the bacterium, Shigella. It is typified by loose stools, frequently containing blood and mucus (dysentery), accompanied by fever, vomiting, cramps and occasionally toxemia.
It can cause bacillary dysentery because of the invasive ability of the organism that may result ulcerations and abscesses of the intestines.
It rarely spreads to the bloodstream.
More severe complications may include convulsions in children, Reiter’s syndrome and hemolytic uremic syndrome depending on the species of Shigella implicated.
It is transmitted primarily by fecal-oral person to person means. It can also occur through contaminated food or water. Those that are primarily responsible for transmission are those that fail to wash their hands thoroughly after defecation.
Because Shigella is resistant to gastric acid, a person can get infected with as little as 10 organisms.
After getting infected symptoms usually appear 1-3 days later. It can be transmitted during the acute phase of infection till approximately four weeks after illness when the organism is no longer present in the feces. Asymptomatic carriers can also infect others.
Diagnosis is confirmed through bacteriological culture of feces. Treatment of shigellosis may include fluid and electrolyte replacement if there are signs of dehydration.
Antibiotics can shorten the course of infection, the severity of illness and the period of time a person may excrete the pathogen. Because of some antibiotic resistance, a antibiotic susceptibility test should be performed to determine which antibiotic will be effective.