Your session is about to expire
← Back to Search
Virus Therapy
Vaccine Strain CVD 1208S-122 for Shigellosis
Phase 1
Waitlist Available
Led By Wilbur Chen, MD, MS
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female, 18 - 49 years of age
Be between 18 and 65 years old
Must not have
Abnormal bowel habits, as defined by <3 stools per week or >2 stools per day in the past 6 months
Regular use (≥once weekly) of laxatives, anti-diarrheal agents, anti-constipation agents, or antacid therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the entire study period (6-7 months)
Summary
This trial is testing a new oral vaccine designed to protect against two types of bacteria that cause stomach illnesses. Healthy volunteers will take the vaccine to see if it is safe and helps their immune system recognize these bacteria. The vaccine uses weakened forms of the bacteria to train the body without causing illness.
Who is the study for?
Healthy adults aged 18-49 who can stay inpatient for up to 6 days, not part of other trials, and women must use birth control. Excludes pregnant or breastfeeding women, those with poor venous access, prior ETEC/Shigella vaccines or infections within 3 years, abnormal bowel habits, recent antimicrobials or steroids use, psychiatric diseases, immunosuppression conditions, certain occupations (food handling/childcare), recent COVID-19 symptoms without a negative test result.
What is being tested?
The trial is testing the safety and immune response to a live oral vaccine called strain CVD 1208S-122 against Shigella and ETEC infections. Participants will either receive the vaccine candidate or a placebo for comparison.
What are the potential side effects?
Potential side effects are not detailed but may include typical reactions to vaccines such as soreness at injection site, fever, fatigue or allergic reactions. Specific side effects will be monitored due to the novel nature of this vaccine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 49 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had abnormal bowel habits, with less than 3 stools per week or more than 2 stools per day in the last 6 months.
Select...
I use laxatives, anti-diarrheal, anti-constipation, or antacid medications at least once a week.
Select...
I am allergic to quinolone or sulpha drugs.
Select...
I work with food, or care for young children, the elderly, or those with weak immune systems.
Select...
I have not used any form of high-dose steroids in the last 30 days.
Select...
I am currently breastfeeding.
Select...
I haven't taken any antibiotics in the last 2 weeks.
Select...
I have had symptoms like fever, chills, muscle pain, headache, sore throat, or loss of taste/smell recently.
Select...
I have a long-term stomach or bowel condition like severe indigestion, lactose intolerance, or IBS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the entire study period (6-7 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the entire study period (6-7 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Geometric Mean Number of Vaccine Organisms
Number and Proportion of Sequential Days of Fecal Shedding of Shigella Organisms
Number, Proportion, Severity, and Relatedness of Non-Serious Unsolicited Adverse Reactions
+5 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4: Shigella Vaccine or PlaceboExperimental Treatment2 Interventions
2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
Group II: Cohort 3: Shigella Vaccine at 10^10 cfu or PlaceboExperimental Treatment2 Interventions
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Group III: Cohort 2: Shigella Vaccine at 10^9 cfu or PlaceboExperimental Treatment2 Interventions
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Group IV: Cohort 1: Shigella Vaccine at 10^8 cfu or PlaceboExperimental Treatment2 Interventions
3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Enterotoxigenic E. coli (ETEC) infection include oral rehydration therapy, antibiotics, and vaccines. Oral rehydration therapy works by replenishing fluids and electrolytes lost due to diarrhea, which is crucial for preventing dehydration.
Antibiotics, such as ciprofloxacin, target and kill the bacteria, reducing the duration and severity of symptoms. Live attenuated vaccines, like the CVD 1208S-122, stimulate the immune system to recognize and fight off ETEC and Shigella by mimicking natural infection without causing disease.
This immune response is particularly important for ETEC patients as it can provide long-term protection and reduce the incidence of future infections.
Correlation between intestinal immune response to colonization factor antigen/I and acquired resistance to enterotoxigenic Escherichia coli diarrhea in an adult rabbit model.
Correlation between intestinal immune response to colonization factor antigen/I and acquired resistance to enterotoxigenic Escherichia coli diarrhea in an adult rabbit model.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
710 Previous Clinical Trials
379,105 Total Patients Enrolled
Wilbur Chen, MD, MSPrincipal InvestigatorCenter for Vaccine Development and Global Health, University of Maryland School of Medicine
2 Previous Clinical Trials
1,325 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any immune-affecting drugs in the last 30 days.You have a history of alcohol or drug abuse in the past 5 years.I have a weakened immune system due to cancer, past cancer treatments, or an immune disorder.I have had diarrhea from traveling to a developing country in the last 3 years.I can stay in the hospital for up to 6 days if needed.I have a history of seizures, but childhood seizures that are resolved are okay.I am generally in good health according to my medical history.I have had abnormal bowel habits, with less than 3 stools per week or more than 2 stools per day in the last 6 months.I have been vaccinated or infected with ETEC, LT, cholera, or Shigella in the last 3 years.I use laxatives, anti-diarrheal, anti-constipation, or antacid medications at least once a week.The investigator believes that any other factors may make it unsafe or difficult for you to participate in the study or may affect the study's results.You have been diagnosed with schizophrenia or another serious mental illness.I am allergic to quinolone or sulpha drugs.I work with food, or care for young children, the elderly, or those with weak immune systems.I have had a cough, shortness of breath, or difficulty breathing not caused by another condition in the last 14 days.I am between 18 and 49 years old.I have not used any form of high-dose steroids in the last 30 days.I haven't had major stomach surgery, except for appendix or gallbladder removal over a year ago.Your body's important signs like heart rate, blood pressure, and temperature are not normal.I am currently breastfeeding.I haven't taken any antibiotics in the last 2 weeks.I have had symptoms like fever, chills, muscle pain, headache, sore throat, or loss of taste/smell recently.I agree to use birth control during and 4 weeks after the trial.I have a long-term stomach or bowel condition like severe indigestion, lactose intolerance, or IBS.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: Shigella Vaccine at 10^8 cfu or Placebo
- Group 2: Cohort 2: Shigella Vaccine at 10^9 cfu or Placebo
- Group 3: Cohort 3: Shigella Vaccine at 10^10 cfu or Placebo
- Group 4: Cohort 4: Shigella Vaccine or Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger