Vaccine Strain CVD 1208S-122 for Shigellosis

Overseen By Connie Thomas, RN

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Maryland, Baltimore

Must not be taking: Antimicrobials, Steroids, Immunomodulators, others

Disqualifiers: Pregnancy, Breastfeeding, Gastrointestinal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 7 days

53 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Wilbur Chen, MD, MS

Principal Investigator

Center for Vaccine Development and Global Health, University of Maryland School of Medicine

Eligibility Criteria

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.

Inclusion Criteria

Written informed consent provided

A passing score (≥70%) on a Comprehension Assessment Tool

For Participants of Cohorts 1-3 during the time when a U.S. Public Health Emergency for COVID-19 exists, SARS-CoV-2 testing must be performed upon admission to the inpatient ward and must document a negative test result prior to vaccination.

Exclusion 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.

Poor venous access, as defined by inability to obtain venous blood, for screening labs, after 3 venipuncture attempts

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of the study vaccine or placebo in a dose-escalation format, followed by monitoring for safety and immunogenicity

7 days

Inpatient stay for 4 days, followed by outpatient monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse reactions and fecal shedding

28 days

Long-term follow-up

Monitoring for serious adverse events and SUSARs throughout the study period

6-7 months

Treatment Details

Interventions

• Strain CVD 1208S-122

Trial Overview 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.

Participant Groups

Group I: Cohort 4: Shigella Vaccine or Placebo Experimental Treatment 2 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 Placebo Experimental Treatment 2 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 Placebo Experimental Treatment 2 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 Placebo Experimental Treatment 2 Interventions

3:1 randomization to one dose of vaccine or placebo (Cohort n=8)

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+