Risk ReductionPhase 1NCT03981952
Salmonella Conjugates CVD 1000: Study of Responses to Vaccination With Trivalent Invasive Salmonella Disease Vaccine
A Phase 1 study testing Trivalent Invasive Salmonella Disease Vaccine (6.25 µg), Trivalent Invasive Salmonella Disease Vaccine (12 µg) and Trivalent Invasive Salmonella Disease Vaccine (25 µg) in people with Risk Reduction, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction
- What is being tested?
- Trivalent Invasive Salmonella Disease Vaccine (6.25 µg), Trivalent Invasive Salmonella Disease Vaccine (12 µg) and Trivalent Invasive Salmonella Disease Vaccine (25 µg)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2019to 7 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to provide written informed consent
- Age 18 - 45 years, inclusive
- Good general health as determined by: vital signs (heart rate <100 bpm; blood pressure systolic >90 mm Hg and ≤150 mm Hg; diastolic >45 mm Hg and ≤90 mm Hg; oral temperature <100.4ºF), medical history, and a physical examination† within 45 days before administration of first dose of vaccine.
- Expressed interest and availability to fulfill the study requirements
- For females of child-bearing potential*, must agree to acceptable birth control\&, 4 weeks before enrollment and through 4 weeks after last vaccination.
- Agrees not to participate in another clinical trial at any time during the study period.
- Agrees to allow for the indefinite storage of blood samples for future research use.
Who cannot join
- 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.
- Hemoglobin, white blood cell (WBC) count, absolute neutrophil count (ANC), or platelet count of an unacceptable value, according to Appendix B
- Creatinine, AST, ALT, total bilirubin, or C-reactive protein of an unacceptable value, according to Appendix B
- Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen.
- (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.)
Show all 19Show fewer
- For women of child-bearing potential, positive serum pregnancy test (during screening within 45 days of enrollment) or positive urine pregnancy test (prior to and within 24 hours of administering each dose of vaccine).
- Nursing mother.
- Temperature > 38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 3 days prior to each dose of vaccine.
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- Diagnosis of schizophrenia or other major psychiatric disease
- Failure to pass Comprehension Assessment Tool during screening (70% correct answers are required to pass).
- Receipt of an experimental agent (vaccine, drug, device, etc.) within 28 days before enrollment or expects to receive an experimental agent during the study period.
- Receipt of any licensed vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) before enrollment in this study.
- Known sensitivity to any ingredient in the study vaccine, including a history of severe allergic reaction to tetanus vaccine.
- Receipt of immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
- Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
- Long-term use (>2 weeks) of oral or parenteral steroids (glucocorticoids), or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201
About this study
Official title: Phase 1 Randomized, Placebo-Controlled, Dose-Escalation Study of the Safety, Reactogenicity, and Immunogenicity of Trivalent (S. Enteritidis/S. Typhimurium/S. Typhi Vi) Conjugate Vaccine Against Invasive Salmonella Disease Administered Parenterally to Healthy U.S. Adults
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.
- Conditions
- Risk Reduction
- Being tested
- Trivalent Invasive Salmonella Disease Vaccine (6.25 µg), Trivalent Invasive Salmonella Disease Vaccine (12 µg), Trivalent Invasive Salmonella Disease Vaccine (25 µg), Trivalent Invasive Salmonella Disease Vaccine (highest, well-tolerated dose among Cohorts A-C), Placebo
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
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).
PlaceboOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Trivalent Invasive Salmonella Disease Vaccine (6.25 µg); Other: Placebo |
| 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. Receives: Biological: Trivalent Invasive Salmonella Disease Vaccine (12 µg); Other: Placebo |
| 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. Receives: Biological: Trivalent Invasive Salmonella Disease Vaccine (25 µg); Other: Placebo |
| 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. Receives: Biological: Trivalent Invasive Salmonella Disease Vaccine (highest, well-tolerated dose among Cohorts A-C); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Approximately one and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start28 Oct 2019
- Primary completion7 May 2021
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Risk ReductionStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilbur Chen, MD, MS, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981952
- Sponsor's protocol ID
- HP-00084998
- Status last verified
- Mar 2025
- First submitted
- 7 Jun 2019
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41062830Chen 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.
PubMed 41001453
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Randomized, Placebo-Controlled, Dose-Escalation Study of the Safety, Reactogenicity, and Immunogenicity of Trivalent (S. Enteritidis/S. Typhimurium/S. Typhi Vi) Conjugate Vaccine Against Invasive Salmonella Disease Administered Parenterally to Healthy U.S. Adults
- ClinicalTrials.gov ID
- NCT03981952
- Acronym / sponsor ID
- HP-00084998
- Conditions
- Risk Reduction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A (Step 1) | Experimental | Biological: Trivalent Invasive Salmonella Disease Vaccine (6.25 µg), Other: PlaceboIndividuals receive one dose of either 6.25 µg of the trivalent vaccine or placebo. Subsequent blood samples are taken for immunological testing. |
| Cohort B (Step 2) | Experimental | Biological: Trivalent Invasive Salmonella Disease Vaccine (12 µg), Other: PlaceboIndividuals receive one dose of either 12.5 µg of the trivalent vaccine or placebo. Subsequent blood samples are taken for immunological testing. |
| Cohort C (Step 3) | Experimental | Biological: Trivalent Invasive Salmonella Disease Vaccine (25 µg), Other: PlaceboIndividuals receive one dose of either 25 µg of the trivalent vaccine or placebo. Subsequent blood samples are taken for immunological testing. |
| Cohort D | Experimental | Biological: Trivalent Invasive Salmonella Disease Vaccine (highest, well-tolerated dose among Cohorts A-C), Other: PlaceboIndividuals 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Ability to provide written informed consent
- Age 18 - 45 years, inclusive
- Good general health as determined by: vital signs (heart rate <100 bpm; blood pressure systolic >90 mm Hg and ≤150 mm Hg; diastolic >45 mm Hg and ≤90 mm Hg; oral temperature <100.4ºF), medical history, and a physical examination† within 45 days before administration of first dose of vaccine.
- Expressed interest and availability to fulfill the study requirements
- For females of child-bearing potential*, must agree to acceptable birth control\&, 4 weeks before enrollment and through 4 weeks after last vaccination.
Key exclusion criteria (19 listed)
- 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.)
- For women of child-bearing potential, positive serum pregnancy test (during screening within 45 days of enrollment) or positive urine pregnancy test (prior to and within 24 hours of administering each dose of vaccine).
- Nursing mother.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trivalent Invasive Salmonella Disease Vaccine (6.25 µg)6.25 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1. | Biological | Cohort A (Step 1) |
| Trivalent Invasive Salmonella Disease Vaccine (12 µg)12 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1. | Biological | Cohort B (Step 2) |
| Trivalent Invasive Salmonella Disease Vaccine (25 µg)25 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1. | Biological | Cohort C (Step 3) |
| Trivalent Invasive Salmonella Disease Vaccine (highest, well-tolerated dose among Cohorts A-C)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). | Biological | Cohort D |
| Placebo0.5 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). | Other | Cohort A (Step 1), Cohort B (Step 2), Cohort C (Step 3), Cohort D |
Primary outcome
Frequency and Severity of Solicited Local and Systemic AEs
Time frame: Approximately one year
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.
Frequency and Severity of Unsolicited AEs and SAEs
Time frame: Approximately two years
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
Proportion of Responders
Time frame: Approximately one and a half years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Derived from this study: PubMed 41062830Chen 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.
- Derived from this study: PubMed 41001453Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trivalent Invasive Salmonella Disease Vaccine (6.25 µg), Trivalent Invasive Salmonella Disease Vaccine (12 µg) and Trivalent Invasive Salmonella Disease Vaccine (25 µg) in people with Risk Reduction, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and Severity of Solicited Local and Systemic AEs (time frame: Approximately one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03981952, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.