Trivalent Salmonella Vaccine for Salmonella Infections
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and effectiveness of a new vaccine designed to protect against invasive Salmonella disease. Participants will receive varying strengths of the trivalent Salmonella conjugate vaccine or a placebo, helping researchers assess its efficacy and the body's response. Individuals in good health, who have not received a typhoid vaccine or had an infection in the past five years, and who do not have serious ongoing medical issues may be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the Trivalent Salmonella Conjugate Vaccine (TSCV) appears safe. In one study, early trials of the vaccine did not raise any serious safety concerns, as most participants did not experience severe side effects. Another study found that the vaccine was generally well-tolerated, with only mild reactions like soreness at the injection site. These results suggest the vaccine is safe enough for further testing. However, since this trial remains in the early stages, more research is needed to confirm these findings.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about the Trivalent Salmonella Conjugate Vaccine (TSCV) because it potentially offers a new way to prevent invasive Salmonella disease. Unlike traditional treatments that mainly focus on managing symptoms after infection, TSCV aims to prevent the disease from occurring in the first place. This vaccine works by stimulating the immune system to recognize and fight off Salmonella bacteria before they can cause illness. With both full-strength and half-strength formulations being tested, TSCV could offer flexible dosing options, potentially increasing its accessibility and effectiveness compared to existing treatments.
What evidence suggests that this trial's treatments could be effective against invasive Salmonella disease?
Research has shown that similar vaccines effectively reduce Salmonella infections in chickens. Studies on related vaccines in mice also show promising results, indicating a strong immune response. In this trial, participants will receive either a full-strength or half-strength dose of the Trivalent Salmonella Conjugate Vaccine (TSCV), or a placebo. Tests in healthy U.S. adults showed no significant difference in immune response between half-strength and full-strength doses of the vaccine, suggesting that different doses might still work well. Initial evidence supports the idea that the TSCV can trigger an immune response that might protect against serious Salmonella infections.45678
Who Is on the Research Team?
Myron M Levine, MD, DTPH
Principal Investigator
University of Maryland, Baltimore
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and immune response.
What Are the Treatments Tested in This Trial?
Interventions
- Trivalent Salmonella Conjugate Vaccine (TSCV)
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Individuals receive one dose of dilutional half-strength Trivalent Salmonella Conjugate Vaccine (TSCV). Subsequent blood samples are taken for safety and immunological testing.
Individuals receive one dose of half-strength Trivalent Salmonella Conjugate Vaccine (TSCV). Subsequent blood samples are taken for safety and immunological testing.
Individuals receive one dose of full-strength Trivalent Salmonella Conjugate Vaccine (TSCV). Subsequent blood samples are taken for safety and immunological testing.
Individuals receive one dose of placebo. Subsequent blood samples are taken for safety and immunological testing.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor
Citations
1.
clinicaltrials.gov
clinicaltrials.gov/study/NCT05525546?term=salmonella%20enterica%20subsp.%20enterica%20serovar%20enteritidis&viewType=Table&rank=4Salmonella Conjugates CVD 2000: Study of Responses to ...
This is a randomized, placebo-controlled interventional study. The main purpose of this research is to test the safety and measure the immune response of ...
Trivalent Salmonella Conjugate Vaccine (TSCV)
This is an age-descending, randomized, placebo-controlled trial that will evaluate the safety and immunogenicity of a Trivalent Salmonella conjugate vaccine ( ...
Non-typhoidal Salmonella combination vaccines
No significant difference was observed between the half-strength (HS) and full-strength (FS) doses of the vaccine in healthy U.S. adults, but no dose decisions ...
Salmonella Conjugates CVD 2000: Study of Responses to ...
Research shows that similar trivalent vaccines have been effective in reducing Salmonella infections in chickens, and other studies on related vaccines in mice ...
Title: A phase 1 randomized, placebo-controlled trial of a ...
The Trivalent Salmonella Conjugate Vaccine (TSCV) was manufactured by Bharat Biotech ... immune responses observed with quarter-strength and half- ...
6.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05784701/trivalent-salmonella-conjugate-vaccine-tscvTrivalent Salmonella Conjugate Vaccine (TSCV)
This is an age-descending, randomized, placebo-controlled trial that will evaluate the safety and immunogenicity of a Trivalent Salmonella conjugate vaccine ( ...
7.
cidrap.umn.edu
cidrap.umn.edu/salmonella/vaccine-typhoid-invasive-salmonella-shows-promise-phase-1-trialVaccine for typhoid, invasive Salmonella shows promise in ...
The primary safety end points were serious and non-serious adverse events, and the primary immunogenicity end point was the serum immunoglobulin ...
Safety and immunogenicity of the invasive non-typhoidal ...
The iNTS-GMMA vaccine was immunogenic and did not show safety concerns precluding further development, supporting progression to further phase I and II clinical ...
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