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Virus Therapy

Vaccine Strain CVD 1208S-122 for Shigellosis

Phase 1
Recruiting
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
Available for up to a 6-day inpatient stay
Determined to be in good health* based on medical history and review of concomitant medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the entire study period (6-7 months)
Awards & highlights

Study Summary

This trial will test a new vaccine for safety and how well it works.

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.Check my eligibility
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.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 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 below
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I can stay in the hospital for up to 6 days if needed.
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I am generally in good health according to my medical history.
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I am between 18 and 49 years old.
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I agree to use birth control during and 4 weeks after the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the entire study period (6-7 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and the entire study period (6-7 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more

Trial 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)

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
685 Previous Clinical Trials
372,992 Total Patients Enrolled
Wilbur Chen, MD, MSPrincipal InvestigatorCenter for Vaccine Development and Global Health, University of Maryland School of Medicine
2 Previous Clinical Trials
1,200 Total Patients Enrolled

Media Library

Strain CVD 1208S-122 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04634513 — Phase 1
Enterotoxigenic E. coli Infection Research Study Groups: Cohort 1: Shigella Vaccine at 10^8 cfu or Placebo, Cohort 2: Shigella Vaccine at 10^9 cfu or Placebo, Cohort 3: Shigella Vaccine at 10^10 cfu or Placebo, Cohort 4: Shigella Vaccine or Placebo
Enterotoxigenic E. coli Infection Clinical Trial 2023: Strain CVD 1208S-122 Highlights & Side Effects. Trial Name: NCT04634513 — Phase 1
Strain CVD 1208S-122 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04634513 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scale of participation for this investigation?

"Affirmative. Clinicaltrials.gov reveals that this medical investigation, which was initially posted on September 29th 2022 is still accepting candidates. 54 patients need to be enrolled from one location for the study's completion."

Answered by AI

Are there any openings to join this experiment as a participant?

"Affirmative. Clinicaltrials.gov informs us that this experiment, first published on September 29th 2022, is in search of test subjects at the time of writing. A total of 54 participants need to be enrolled from one centre."

Answered by AI

Are elderly individuals welcome to participate in this experimental procedure?

"This trial has set the lower and upper age limits at 18 and 49 years old, respectively. Therefore, all participants must be within this range to satisfy eligibility requirements."

Answered by AI

Is it possible for me to take part in this clinical experiment?

"This clinical trial is seeking 54 individuals between 18 and 49 years of age with shigella infection. Participants must be in good health as defined by an absence of a chronic medical condition that requires daily prescription medication, although infrequent PRN medications are allowed at the investigator's discretion. Furthermore, any chronic illness which could lead to rapid dehydration would make participants ineligible for this study."

Answered by AI

What risks do individuals face when exposed to strain CVD 1208S-122?

"The safety of strain CVD 1208S-122 has been deemed a 1, which reflects the fact that this is only in its first phase clinical trial. This suggests limited data indicating efficacy and safety at present."

Answered by AI
~5 spots leftby May 2024