Risk ReductionPhase 1NCT05525546
Salmonella Conjugates CVD 2000: Study of Responses to Vaccination With Trivalent Salmonella Conjugate Vaccine to Prevent Invasive Salmonella Disease
A Phase 1 study testing Trivalent Salmonella Conjugate Vaccine (TSCV) Full-Strength Formulation, Trivalent Salmonella Conjugate Vaccine (TSCV) Half-Strength Formulation and Trivalent Salmonella Conjugate Vaccine (TSCV) Dilutional Half-Strength Formulation 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 interventional 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 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction
- What is being tested?
- Trivalent Salmonella Conjugate Vaccine (TSCV) Full-Strength Formulation, Trivalent Salmonella Conjugate Vaccine (TSCV) Half-Strength Formulation and Trivalent Salmonella Conjugate Vaccine (TSCV) Dilutional Half-Strength Formulation
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 12 Jun 2023
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to provide written informed consent
- Age 18 - 49 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.
- † The intent is to evaluate for acute or ongoing chronic medical conditions which have been present for 90 days or more and which could affect the assess of safety or immunogenicity. Chronic medical conditions should be stable for at least 60 days; defined as no hospitalizations, ER, or urgent care for medical intervention and no change in chronic prescription medications for at least 60 days. Changes in medications due to insurance or financial reasons and when within the same class of medications or changes for improvements in medical conditions are not exclusionary. Medications which are taken prn are also no exclusionary.
- 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.
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- females of child-bearing potential are defined as: not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure® placement (permanent, nonsurgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year of the last menses if menopausal.
- \& acceptable birth control includes: non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the first study vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, and licensed hormonal methods such as implants, injectables, or oral contraceptives.
- 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.
- Complies with Pharmaron's Coronavirus disease 2019 (Covid 19) policy.
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
- Creatinine, Aspartate Aminotransferase (AST), Alanine aminotransferase (ALT), total bilirubin, or C-reactive protein of an unacceptable value c. 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, Human Immunodeficiency Virus (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).
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- 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 vaccination.
- This exclusion criterion is to be used for the duration that there is a U.S. Public Health Emergency for COVID-19; once the declaration has ended, this criterion will not be used. Temperature > 38.0°C (100.4°F) or symptoms of a COVID-19 infection# within 10 days prior to vaccination.
- Symptoms of a COVID-19 infection include fever, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea.
- https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
- 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 the Comprehension Assessment Tool test during screening (70% correct answers are required to pass. Subjects will be provided the opportunity to repeat the test once).
- 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.
About this study
Official title: Phase 1 Randomized, Placebo-Controlled, Study to Compare the Safety, Reactogenicity, and Immunogenicity of a Full-Strength Formulation of Trivalent Salmonella (S. Enteritidis/S. Typhimurium/S. Typhi Vi) Conjugate Vaccine (TSCV), a Half-Strength Formulation of TSCV, and a Dilutional Half-Strength Dose of TSCV Against Invasive Salmonella Disease Administered Parenterally to Healthy U.S. Adults
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 the trivalent vaccine against invasive Salmonella disease. The vaccine will be tested over a range of doses.
- Conditions
- Risk Reduction
- Being tested
- Trivalent Salmonella Conjugate Vaccine (TSCV) Full-Strength Formulation, Trivalent Salmonella Conjugate Vaccine (TSCV) Half-Strength Formulation, Trivalent Salmonella Conjugate Vaccine (TSCV) Dilutional Half-Strength Formulation, 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 Salmonella Conjugate Vaccine (TSCV) Full-Strength FormulationBiological
One dose of the full-strength conjugate vaccine is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The full-strength conjugate vaccine consists of 25 mcg of each conjugate; Salmonella Enteritidis, Salmonella Typhimurium, and Salmonella Typhi Vi.
Trivalent Salmonella Conjugate Vaccine (TSCV) Half-Strength FormulationBiological
One dose of the half-strength conjugate vaccine is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The half-strength conjugate vaccine consists of 12.5 mcg of Salmonella Enteritidis, 12.5 mg of Salmonella Typhimurium, and 25 mcg of Salmonella Typhi Vi.
Trivalent Salmonella Conjugate Vaccine (TSCV) Dilutional Half-Strength FormulationBiological
One dose of the dilutional half-strength conjugate vaccine is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The dilutional half-strength conjugate vaccine consists of 12.5 mcg of each conjugate; Salmonella Enteritidis, Salmonella Typhimurium, and Salmonella Typhi Vi.
PlaceboOther
One dose of placebo is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The placebo consists of sterile phosphate-buffered saline (PBS) solution containing polysorbate 80, and 2-phenoxyethanol preservative.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Full-Strength Formulation | Experimental | Individuals receive one dose of full-strength Trivalent Salmonella Conjugate Vaccine (TSCV). Subsequent blood samples are taken for safety and immunological testing. Receives: Biological: Trivalent Salmonella Conjugate Vaccine (TSCV) Full-Strength Formulation |
| Group B: Half-Strength Formulation | Experimental | Individuals receive one dose of half-strength Trivalent Salmonella Conjugate Vaccine (TSCV). Subsequent blood samples are taken for safety and immunological testing. Receives: Biological: Trivalent Salmonella Conjugate Vaccine (TSCV) Half-Strength Formulation |
| Group C: Dilutional Half-Strength Formulation | Experimental | Individuals receive one dose of dilutional half-strength Trivalent Salmonella Conjugate Vaccine (TSCV). Subsequent blood samples are taken for safety and immunological testing. Receives: Biological: Trivalent Salmonella Conjugate Vaccine (TSCV) Dilutional Half-Strength Formulation |
| Group D: Placebo | Placebo comparator | Individuals receive one dose of placebo. Subsequent blood samples are taken for safety and immunological testing. Receives: 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 Adverse Events (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 six months
Frequency and Severity of Unsolicited AEs and Serious Adverse Events (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 six months
Proportion of Responders
To measure the proportion of subjects that achieve a four-fold increase in titer, as compared to baseline, of specific serum Immunoglobulin G (IgG) anti-Core-O polysaccharide (anti-COPS) (S. Enteritidis or S. Typhimurium), anti-Vi (S. Typhi) polysaccharide, and anti-Flagellin subunit protein (anti-FliC) (S. Enteritidis or S. Typhimurium) antibody at day 29, as measured by Enzyme-linked immunosorbent assay (ELISA).
Measured: approximately six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start15 Aug 2022
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 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
- Investigators
- Myron M Levine, MD, DTPH, Study director, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525546
- Sponsor's protocol ID
- HP-00099225
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Randomized, Placebo-Controlled, Study to Compare the Safety, Reactogenicity, and Immunogenicity of a Full-Strength Formulation of Trivalent Salmonella (S. Enteritidis/S. Typhimurium/S. Typhi Vi) Conjugate Vaccine (TSCV), a Half-Strength Formulation of TSCV, and a Dilutional Half-Strength Dose of TSCV Against Invasive Salmonella Disease Administered Parenterally to Healthy U.S. Adults
- ClinicalTrials.gov ID
- NCT05525546
- Acronym / sponsor ID
- HP-00099225
- Conditions
- Risk Reduction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 1 Sep 2022 (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 interventional 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
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: Full-Strength Formulation | Experimental | Biological: Trivalent Salmonella Conjugate Vaccine (TSCV) Full-Strength FormulationIndividuals receive one dose of full-strength Trivalent Salmonella Conjugate Vaccine (TSCV). Subsequent blood samples are taken for safety and immunological testing. |
| Group B: Half-Strength Formulation | Experimental | Biological: Trivalent Salmonella Conjugate Vaccine (TSCV) Half-Strength FormulationIndividuals receive one dose of half-strength Trivalent Salmonella Conjugate Vaccine (TSCV). Subsequent blood samples are taken for safety and immunological testing. |
| Group C: Dilutional Half-Strength Formulation | Experimental | Biological: Trivalent Salmonella Conjugate Vaccine (TSCV) Dilutional Half-Strength FormulationIndividuals receive one dose of dilutional half-strength Trivalent Salmonella Conjugate Vaccine (TSCV). Subsequent blood samples are taken for safety and immunological testing. |
| Group D: Placebo | Placebo comparator | Other: PlaceboIndividuals receive one dose of placebo. Subsequent blood samples are taken for safety and immunological testing. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Ability to provide written informed consent
- Age 18 - 49 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.
- † The intent is to evaluate for acute or ongoing chronic medical conditions which have been present for 90 days or more and which could affect the assess of safety or immunogenicity. Chronic medical conditions should be stable for at least 60 days; defined as no hospitalizations, ER, or urgent care for medical intervention and no change in chronic prescription medications for at least 60 days. Changes in medications due to insurance or financial reasons and when within the same class of medications or changes for improvements in medical conditions are not exclusionary. Medications which are taken prn are also no exclusionary.
- Expressed interest and availability to fulfill the study requirements
Key exclusion criteria (21 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, Human Immunodeficiency Virus (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 Salmonella Conjugate Vaccine (TSCV) Full-Strength FormulationOne dose of the full-strength conjugate vaccine is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The full-strength conjugate vaccine consists of 25 mcg of each conjugate; Salmonella Enteritidis, Salmonella Typhimurium, and Salmonella Typhi Vi. | Biological | Group A: Full-Strength Formulation |
| Trivalent Salmonella Conjugate Vaccine (TSCV) Half-Strength FormulationOne dose of the half-strength conjugate vaccine is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The half-strength conjugate vaccine consists of 12.5 mcg of Salmonella Enteritidis, 12.5 mg of Salmonella Typhimurium, and 25 mcg of Salmonella Typhi Vi. | Biological | Group B: Half-Strength Formulation |
| Trivalent Salmonella Conjugate Vaccine (TSCV) Dilutional Half-Strength FormulationOne dose of the dilutional half-strength conjugate vaccine is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The dilutional half-strength conjugate vaccine consists of 12.5 mcg of each conjugate; Salmonella Enteritidis, Salmonella Typhimurium, and Salmonella Typhi Vi. | Biological | Group C: Dilutional Half-Strength Formulation |
| PlaceboOne dose of placebo is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The placebo consists of sterile phosphate-buffered saline (PBS) solution containing polysorbate 80, and 2-phenoxyethanol preservative. | Other | Group D: Placebo |
Primary outcome
Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs)
Time frame: Approximately six months
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 Serious Adverse Events (SAEs)
Time frame: Approximately six months
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 six months
To measure the proportion of subjects that achieve a four-fold increase in titer, as compared to baseline, of specific serum Immunoglobulin G (IgG) anti-Core-O polysaccharide (anti-COPS) (S. Enteritidis or S. Typhimurium), anti-Vi (S. Typhi) polysaccharide, and anti-Flagellin subunit protein (anti-FliC) (S. Enteritidis or S. Typhimurium) antibody at day 29, as measured by Enzyme-linked immunosorbent assay (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 21 Sep 2023.
- 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.
Myron M Levine, MD, DTPH study director
University of Maryland, Baltimore
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 Salmonella Conjugate Vaccine (TSCV) Full-Strength Formulation, Trivalent Salmonella Conjugate Vaccine (TSCV) Half-Strength Formulation and Trivalent Salmonella Conjugate Vaccine (TSCV) Dilutional Half-Strength Formulation 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 11 inclusion and 21 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 21 Sep 2023. 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. Some participants in this study may receive a placebo. 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 Adverse Events (AEs) (time frame: Approximately six months). 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?
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 21 Sep 2023.