What side effects are associated with this type of intervention?

Common treatments for Enterotoxigenic E. coli (ETEC) infections include live attenuated vaccines, such as the one studied in the CVD 1208S-122 trial. Known side effects of these vaccines typically include mild gastrointestinal symptoms like nausea, vomiting, and diarrhea. Other potential side effects may include fever, headache, and localized reactions at the site of administration. Serious adverse events are rare but can include allergic reactions. Overall, these vaccines are generally well-tolerated with a favorable safety profile.

What prior FDA approvals exist?

As of now, there are no FDA-approved vaccines specifically targeting Enterotoxigenic E. coli (ETEC) infections. The live attenuated vaccine CVD 1208S-122, which is under study, aims to stimulate an immune response against both Shigella and ETEC. Current treatments for ETEC primarily involve supportive care, including rehydration and antibiotics such as ciprofloxacin or azithromycin, rather than preventive vaccines. The development of vaccines like CVD 1208S-122 represents a promising advancement in the prevention of ETEC-related diarrhea.

What other types of research exist?

Promising alternatives to the CVD 1208S-122 vaccine for ETEC infection include: 1) Attenuated E. coli strains such as E. coli K88ac LT(S63K)ΔSTb, which has shown to stimulate mucosal immune response and provide protection in mouse models. 2) Dietary supplementation with bacteriophages targeting ETEC K88, which has been effective in reducing clinical symptoms in post-weaning pigs. 3) Probiotic strains like Escherichia coli Nissle 1917 (EcN), which have demonstrated preventive effects against acute secretory diarrhea in pig models.

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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 below

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I am between 18 and 49 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

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I use laxatives, anti-diarrheal, anti-constipation, or antacid medications at least once a week.

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I am allergic to quinolone or sulpha drugs.

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I work with food, or care for young children, the elderly, or those with weak immune systems.

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I have not used any form of high-dose steroids in the last 30 days.

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I am currently breastfeeding.

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I haven't taken any antibiotics in the last 2 weeks.

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I have had symptoms like fever, chills, muscle pain, headache, sore throat, or loss of taste/smell recently.

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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)

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

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 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)

0 / 10Eligibility criteria met

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.