Your session is about to expire
← Back to Search
Live-attenuated Vaccine
Shigella sonnei strain 53G for Immunizations
Phase 2
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
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 days 64, 71, 85, and 113
Awards & highlights
Study Summary
This trial is to see if a vaccine candidate is safe, effective, and causes an immune response in 120 healthy adults. The study will last for 24 months, and participants will be in the study for 8 months.
Who is the study for?
Healthy adults aged 18-49, with stable blood pressure and no severe medical conditions or recent drug abuse. Women must not be pregnant and should use contraception. Excludes those with immune deficiencies, certain infections like HIV/Hepatitis B/C, history of Shigella vaccination or infection, immunosuppressive therapy users, and individuals who have taken specific medications recently.Check my eligibility
What is being tested?
The trial is testing an oral live-attenuated S. sonnei vaccine called WRSs2 against a placebo in two phases: first the vaccination phase then the challenge phase with S. sonnei strain 53G to assess efficacy in preventing shigellosis.See study design
What are the potential side effects?
Some participants experienced Grade 3 diarrhea and/or vomiting after receiving the vaccine dose which led to a reduction in dosage for subsequent subjects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 64, 71, 85, and 113
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 64, 71, 85, and 113
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Duration of shedding 53G post-challenge
Duration of shedding S. sonnei by culture post-vaccination
Maximum S. sonnei LPS-specific and Invaplex-specific serum IgG and IgA titer by ELISA
+9 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 2Experimental Treatment3 Interventions
Placebo + Vaccine: 30 ml of sterile normal saline placebo administered orally on Day 1 and 1 ml of saline containing 10^6 cfu of the WRSs2 vaccine in 30 ml of sterile normal saline administered orally on Day 29. Challenge: 1 ml of S. sonnei 53G challenge in 30ml of sterile saline administered orally on Day 57. N=40
Group II: Arm 1Experimental Treatment3 Interventions
Vaccine: 1 ml of saline containing10^6 or 5X10^5 cfu of the WRSs2 vaccine in 30 ml of sterile normal saline administered orally on Day 1 and Day 29. Challenge: 1 ml of S. sonnei 53G challenge in 30 ml of sterile saline administered orally on Day 57. N=40
Group III: Arm 3Placebo Group3 Interventions
Placebo: 31 ml of sterile normal saline placebo administered orally on Day 1 and Day 29. Challenge: 1 ml of S. sonnei 53G challenge in 30 ml of sterile saline administered orally on Day 57. N=40
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
WRSs2
2013
Completed Phase 1
~90
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,274 Previous Clinical Trials
5,484,240 Total Patients Enrolled
5 Trials studying Immunizations
271 Patients Enrolled for Immunizations
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have allergies to ciprofloxacin, trimethoprim-sulfamethoxazole, sodium bicarbonate, or any ingredients in the vaccine, placebo, or challenge material.I can follow the study's procedures and attend all visits.You have had problems with alcohol or drug abuse within the past year.I have not received a live vaccine within the last 30 days.I am a woman who can have children and have a recent negative pregnancy test.I am currently using or have recently used drugs that affect my immune system.I have used and will continue to use effective birth control during the study.I have tested positive for HLA-B27, HIV, Hepatitis B, or Hepatitis C.I have not taken meds like aspirin, ibuprofen, or acetaminophen in the last 2 days.I have not used any experimental treatments in the last 30 days.I have used steroids in the past month.I have not had a fever or been acutely ill in the last 72 hours.Your heart rate is between 50 and 100 beats per minute.I have a history of immune system problems due to genetics, illness, or treatments.You or someone in your family has had a condition called reactive arthritis in the past.I have a history of HIV, Hepatitis B, or Hepatitis C.I usually have less than 3 or more than 3 bowel movements a day.I haven't had chemotherapy or radiation for cancer in the last 3 years, except for non-melanoma skin cancer.I have received or plan to receive a COVID-19 or flu vaccine around the time of the study product.I have had diarrhea in the last two weeks.I am between 18 and 49 years old and in good health.I have a history of inflammatory bowel disease.I have not had irritable bowel syndrome or uncontrolled stomach issues in the last year.I have not received blood products, except for Rho D Ig, in the last 90 days.I have not taken antibiotics in the week before joining.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 3
- Group 2: Arm 1
- Group 3: Arm 2
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.
Are middle-aged adults admissible to this particular clinical trial?
"This particular clinical trial is only enrolling patients that are between 18-49 years old. If you do not meet this age requirement, there are 8 other trials for individuals under the age of majority and 3 more trials for seniors."
Answered by AI
What are the mortality rates associated with Shigella sonnei strain 53G?
"While there is some evidence backing up Shigella sonnei strain 53G's safety, it only received a 2 because there is no data indicating that the bacteria is effective at treating anything."
Answered by AI
Are participants being recruited for this experiment currently?
"Unfortunately, this study is not looking for new patients at the moment. The trial was posted on 7/26/2022 and updated recently on 7/21/2022. However, there are 16 other clinical trials that might be a better match for you."
Answered by AI
Who does this study target as participants?
"This trial is admitting 120 patients with immunizations between the ages of 18 and 49. Most notable, candidates are required to meet the following criteria: Are able to understand and comply with planned study procedures and be available for all study visits., *Good health is defined by the absence of any exclusionary medical conditions. If the subject has another current, ongoing medical condition, the condition cannot meet any of the following criteria: 1) first diagnosed within 3 months of enrollment; 2) is worsening in terms of clinical outcome in last 6 months; or 3) involves need for medication that may pose a risk to subject's safety or impede assessment"
Answered by AI
Who else is applying?
What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
Cincinnati Children's Hospital Medical Center - Infectious Diseases
The Hope Clinic of Emory University
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Most responsive sites:
- Cincinnati Children's Hospital Medical Center - Infectious Diseases: < 48 hours
Average response time
- < 2 Days
Typically responds via
Phone Call
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger