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Cancer Vaccine
Shigella Vaccine for Shigellosis
Phase 2
Waitlist Available
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately eight months
Awards & highlights
Study Summary
This trial will test a new vaccine for Shigella, a bacteria that causes diarrhea. The vaccine will be given to adults to see if it is safe and effective.
Who is the study for?
Healthy adults aged 18-45 who can provide consent and have passed health screenings including blood tests, stool culture, and a comprehension assessment. Women must agree to use birth control. Participants cannot be pregnant, have had certain gastrointestinal surgeries or substance abuse issues, work in food handling with vulnerable groups, or take medications that affect immune function.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of SF2a-TT15 Shigella vaccine compared to a placebo. The goal is to see if this new vaccine can prevent infection by Shigella bacteria which causes dysentery.See study design
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 risks will be monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately eight months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately eight months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Protective Efficacy calculated as the change in attack rates
Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4: Shigella Vaccine Only, No ChallengeExperimental Treatment1 Intervention
All volunteers receive the investigational Shigella vaccine (n=12). No Shigella challenge.
Group II: Cohort 3: Shigella Vaccine or Placebo, Followed by ChallengeExperimental Treatment3 Interventions
1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22).
Group III: Cohort 2: Shigella Vaccine or Placebo, Followed by ChallengeExperimental Treatment3 Interventions
1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22).
Group IV: Cohort 1: Shigella Vaccine or Placebo, Followed by ChallengeExperimental Treatment3 Interventions
1:1 randomization to investigational Shigella vaccine or placebo (n=30). The majority of participants will then receive the Shigella challenge (n=22).
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Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
687 Previous Clinical Trials
374,588 Total Patients Enrolled
1 Trials studying Shigellosis
52 Patients Enrolled for Shigellosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had problems with drinking alcohol or using drugs in the past 5 years.You have received a vaccine or had an infection caused by ETEC or Shigella in the last 5 years before joining the study.You have taken antibiotics or other antimicrobial medications within two weeks before each dose of the vaccine or the challenge.You regularly use laxatives, anti-diarrheal medications, constipation medications, or antacids at least once a week.You have taken any medication that might weaken your immune system within 30 days before receiving the vaccine or participating in the study.You have a history of a type of arthritis called reactive arthritis.You have been diagnosed with schizophrenia or another serious mental illness.You have a weakened immune system.There may be other reasons, according to the person in charge of the study, that could make it unsafe for you to participate or affect the study's results.You have had seizures in the past 5 years.Your bowel movements have been irregular, either having less than 3 stools per week or more than 2 stools per day, for the past 6 months.Your blood pressure is too high (systolic BP > 150 mmHg or diastolic BP > 90 mmHg), your resting heart rate is too high (greater than 100 beats per minute), or your oral temperature is equal to or greater than 100.4 degrees Fahrenheit.You have had a severe allergic reaction to ciprofloxacin, trimethoprim-sulfamethoxazole (Bactrim), or a tetanus vaccine.You recently traveled to a country where there is a high risk of getting traveler's diarrhea within the past 3 years.You have a history of long-term stomach or digestive problems, such as severe indigestion, lactose intolerance, or other significant digestive diseases.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: Shigella Vaccine or Placebo, Followed by Challenge
- Group 2: Cohort 2: Shigella Vaccine or Placebo, Followed by Challenge
- Group 3: Cohort 4: Shigella Vaccine Only, No Challenge
- Group 4: Cohort 3: Shigella Vaccine or Placebo, Followed by Challenge
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks may one encounter when being administered SF2a-TT15 Shigella Vaccine?
"Our team at Power assigned a safety score of 2 to SF2a-TT15 Shigella Vaccine due to the fact that this is just a Phase 2 trial; while there are some data regarding its security, none exist indicating efficacy."
Answered by AI
What is the greatest number of people participating in this experiment?
"Affirmative. Clinicaltrials.gov data attests that this medical research, which was initially posted on March 2nd 2020, is currently looking for participants. Around 102 people must be recruited from a single site."
Answered by AI
Is there an opportunity for me to become involved in this research endeavor?
"Patients who are afflicted with shigella and between 18 to 45 years of age can be considered for this medical trial. Around 102 individuals will ultimately be selected as participants."
Answered by AI
Is this trial enrolling geriatric individuals?
"Eligibility requirements for this research dictate that only adults aged 18 to 45 may participate."
Answered by AI
Is the trial still accepting participants?
"According to the information on clinicaltrials.gov, this medical trial is presently enrolling participants. This study was first made available on March 2nd 2020 and has since been updated at least once as of May 5th 2022."
Answered by AI
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