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This is a randomized, placebo-controlled dose-escalation study. The main purpose of this research is to test the safety and measure the immune response of the trivalent vaccine against invasive Salmonella disease. The vaccine will be tested over a range of doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A (Step 1) | Experimental | Individuals receive one dose of either 6.25 µg of the trivalent vaccine or placebo. Subsequent blood samples are taken for immunological testing. |
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| Cohort B (Step 2) | Experimental | Individuals receive one dose of either 12.5 µg of the trivalent vaccine or placebo. Subsequent blood samples are taken for immunological testing. |
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| Cohort C (Step 3) | Experimental | Individuals receive one dose of either 25 µg of the trivalent vaccine or placebo. Subsequent blood samples are taken for immunological testing. |
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| Cohort D | Experimental | Individuals receive one or two doses of the highest, well-tolerate dose among Cohorts A-C of the trivalent vaccine or placebo. Subsequent blood samples are taken for immunological testing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trivalent Invasive Salmonella Disease Vaccine (6.25 µg) | Biological | 6.25 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Severity of Solicited Local and Systemic AEs | To assess the frequency and severity of solicited local (i.e., injective site) and systemic (such as fever) AEs during the first 7 days following each dose of vaccine. | Approximately one year |
| Frequency and Severity of Unsolicited AEs and SAEs | To assess the frequency and severity of unsolicited AEs within 28 days of each dose of vaccine and the occurrence of any SAEs through 6 months after the last dose of vaccine | Approximately two years |
| Proportion of Responders | To measure the proportion of subjects that achieve a four-fold increase in titer, as compared to baseline, of specific serum IgG anti-COPS (S. Enteritidis or S. Typhimurium), anti-Vi (S. Typhi) polysaccharide, and anti-FliC (S. Enteritidis or S. Typhimurium) antibody at days 29 and 57, as measured by ELISA. | Approximately one and a half years |
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Inclusion Criteria:
Exclusion Criteria:
History of typhoid vaccination or known history of typhoid infection within 5 years
Unacceptable laboratory abnormality from screening (prior to first vaccination) or upon safety laboratory testing (prior to second vaccination) as listed below. Laboratories with abnormalities which are possibly transient in nature may be repeated one time.
(Subjects will be informed if their results are positive for hepatitis C, HIV antibody or hepatitis B surface antigen and will be referred to a primary care provider for follow up of these abnormal laboratory tests.)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore, Center for Vaccine Development and Global Health | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41062830 | Derived | Chen WH, Barnes RS, Sikorski MJ, Datar R, Sukhavasi R, Liang Y, Rapaka RR, Pasetti MF, Sztein MB, Wahid R, Tennant SM, Simon R, Baliban SM, Galen JE, Lees A, Bernshtein B, Alter G, Ella R, Mohan K, Naidu MG, Rao DY, Ella KM, Levine MM. A combination typhoid and non-typhoidal Salmonella polysaccharide conjugate vaccine in healthy adults: a randomized, placebo-controlled phase 1 trial. Nat Med. 2025 Dec;31(12):4256-4264. doi: 10.1038/s41591-025-04003-z. Epub 2025 Oct 8. | |
| 41001453 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2021 |
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| Trivalent Invasive Salmonella Disease Vaccine (12 µg) | Biological | 12 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1. |
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| Trivalent Invasive Salmonella Disease Vaccine (25 µg) | Biological | 25 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1. |
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| Trivalent Invasive Salmonella Disease Vaccine (highest, well-tolerated dose among Cohorts A-C) | Biological | The highest, well-tolerated dose of the conjugate vaccine among Cohorts A-C is administered via one or two intramuscular injection(s) into the deltoid muscle on Study Day 1 (and 29 if two doses are given). |
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| Placebo | Other | 0.5 mL of buffer and preservative is administered via one or two intramuscular injections(s) into the deltoid muscle on Study Day 1 (and 29 if two doses are given). |
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| Derived |
| Chen WH, Barnes RS, Sikorski MJ, Datar R, Sukhavasi R, Liang Y, Rapaka RR, Pasetti MF, Sztein MB, Wahid R, Tennant SM, Simon R, Baliban SM, Galen JE, Lees A, Bernshtein B, Alter G, Ella R, Mohan K, Naidu MG, Rao DY, Ella KM, Levine MM. A phase 1 randomized, placebo-controlled trial of a combination typhoid and non-typhoidal Salmonella polysaccharide conjugate vaccine. medRxiv [Preprint]. 2025 Sep 18:2025.09.15.25335795. doi: 10.1101/2025.09.15.25335795. |
| Mar 6, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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