Salmonella Conjugates CVD 2000: Study of Responses to Vaccination With Trivalent Salmonella Conjugate Vaccine to Prevent Invasive Salmonella Disease

Overseen By Wilbur Chen, MD, MS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Maryland, Baltimore

Must not be taking: Immunosuppressants, Cytotoxics, Steroids

Disqualifiers: HIV, Hepatitis B/C, Schizophrenia, others

Compensation: Varies

Number of Visits: 7

Duration: 1 day

82 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new vaccine to prevent serious Salmonella infections. It aims to see if the vaccine is safe and how well it helps the immune system fight the bacteria. The study focuses on people at risk of severe Salmonella disease. The recent emergence of multi-drug-resistant Salmonella strains highlights the need for better preventive measures, including vaccination.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, your chronic medications should be stable for at least 60 days, meaning no changes unless they are within the same class or for improvements in your condition.

What data supports the effectiveness of the treatment Trivalent Salmonella Conjugate Vaccine (TSCV)?

Research shows that similar trivalent vaccines have been effective in reducing Salmonella infections in chickens, and other studies on related vaccines in mice have demonstrated strong immune responses and protection against Salmonella. These findings suggest that the Trivalent Salmonella Conjugate Vaccine could be effective in preventing Salmonella infections. ^{1 2 3 4 5}

How is the Trivalent Salmonella Conjugate Vaccine (TSCV) different from other treatments for Salmonella infections?

The Trivalent Salmonella Conjugate Vaccine (TSCV) is unique because it targets multiple Salmonella serotypes (types) simultaneously, which is not common in existing vaccines. It is designed to induce a strong immune response without causing adverse effects, making it a promising option for controlling Salmonella infections in poultry, which are a major source of human infections. ^{1 2 3 6 7}

Research Team

Myron M Levine, MD, DTPH

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

Inclusion Criteria

Ability to provide written informed consent

For females of child-bearing potential*, must agree to acceptable birth control &, 4 weeks before enrollment and through 4 weeks after last vaccination.

Complies with Pharmaron's Coronavirus disease 2019 (Covid 19) policy.

Exclusion Criteria

Receipt of any licensed vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) before enrollment in this study.

You have been diagnosed with schizophrenia or another serious mental illness.

Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one dose of either full-strength, half-strength, or dilutional half-strength Trivalent Salmonella Conjugate Vaccine or placebo. Subsequent blood samples are taken for safety and immunological testing.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and immune response.

6 months

Multiple visits (in-person and virtual) over 6 months

Treatment Details

Interventions

• Trivalent Salmonella Conjugate Vaccine (TSCV)

Participant Groups

Group I: Group C: Dilutional Half-Strength Formulation Experimental Treatment 1 Intervention

Individuals receive one dose of dilutional half-strength Trivalent Salmonella Conjugate Vaccine (TSCV). Subsequent blood samples are taken for safety and immunological testing.

Group II: Group B: Half-Strength Formulation Experimental Treatment 1 Intervention

Individuals receive one dose of half-strength Trivalent Salmonella Conjugate Vaccine (TSCV). Subsequent blood samples are taken for safety and immunological testing.

Group III: Group A: Full-Strength Formulation Experimental Treatment 1 Intervention

Individuals receive one dose of full-strength Trivalent Salmonella Conjugate Vaccine (TSCV). Subsequent blood samples are taken for safety and immunological testing.

Group IV: Group D: Placebo Placebo Group 1 Intervention

Individuals receive one dose of placebo. Subsequent blood samples are taken for safety and immunological testing.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of Multivalent, Cochleate-Based Vaccine against Salmonella Infantis, S. Enteritidis and S. Typhimurium in Laying Hens. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a novel trivalent inactivated vaccine against the shedding of Salmonella in a chicken challenge model. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity and protective efficacy against Salmonella C2-C3 infection in mice immunized with a glycoconjugate of S. Newport Core-O polysaccharide linked to the homologous serovar FliC protein. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Sustained protection in mice immunized with fractional doses of Salmonella Enteritidis core and O polysaccharide-flagellin glycoconjugates. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Immunogenicity of a Bivalent Adjuvanted Glycoconjugate Vaccine against Salmonella Typhimurium and Salmonella Enteritidis. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Flagellin-deficient outer membrane vesicles as adjuvant induce cross-protection of Salmonella Typhimurium outer membrane proteins against infection by heterologous Salmonella serotypes. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Protection of mice against Salmonella typhimurium with an O-specific polysaccharide-protein conjugate vaccine. [2021]