Trivalent Salmonella Conjugate Vaccine (TSCV)

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Mar 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine called the Trivalent Salmonella Conjugate Vaccine (TSCV) to see how safe it is and how well it works in building immunity against Salmonella infections. The trial will include participants of various ages, starting with healthy adults and moving down to infants. If you or a family member are healthy and fit into one of the age groups—ranging from 12 weeks to 35 years old—you may be eligible to participate. It's important that all participants have received their routine vaccinations and that parents of children live close to the study location.

Participants in the trial will receive either the TSCV vaccine or a placebo (which is a harmless substance) and will be monitored for any side effects and immune responses. The trial will follow a structured plan, so participants can expect regular visits for vaccinations and check-ups. Additionally, there are certain health conditions that might exclude someone from joining, such as severe allergies to vaccine components or other serious medical issues. Overall, this study aims to improve vaccine options for protecting against Salmonella, which can cause serious illness, especially in young children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy individuals, female or male
• • Age (all age ranges are inclusive)
• • 1. Step 1A: Adults 20-35 years of age
• • 2. Step 1B: Children, 5-9 years of age
• • 3. Step 1 C: Pre-school children, 24-59 mos. of age
• • 4. Step 1D: Older toddlers, 16-23 months of age
• • 5. Step 2A: Young toddlers, 12-16 months of age
• • 6. Step 2B: Older infants, 8-11 months of age
• • 7. Step 3: Young infants,12-14 weeks of age OR 16-18 weeks of age
• • 8. Step 4: Young infants, 12-18 weeks of age
• • For potential pediatric participants, the parents must live within the catchment area of the clinical study facility at the time of the study vaccinations and must intend to continue to reside in the area for the duration of the study
• • Adult subjects and parents/ guardians of pediatric subjects must have provided informed consent
• • Infant and toddler subjects in Steps 2, 3, and 4 must have received their scheduled EPI vaccines at least 14 days prior to receiving a study product.
• Exclusion Criteria:
• • A history of documented hypersensitivity to any component of the Trivalent Salmonella Conjugate Vaccine or of Typbar-TCV™
• • A history of previous vaccination with any licensed or experimental typhoid vaccine A known history of diabetes, tuberculosis, malignancy, chronic kidney disease, cardiac disease, liver disease, progressive neurological disorder, poorly controlled seizure disorder, or a terminal illness based on participant interview and review of screening laboratory results.
• • Severe malnutrition: i.e., weight-for-length Z-score of less than - 3.
• • Receipt of any other investigational intervention in the last 6 months
• • Known HIV infection or other forms of immunocompromise
• • Receipt of systemic immunosuppressive medication including systemic corticosteroids
• • For Step 1A, for females of child-bearing potential, a positive pregnancy test at the time of enrollment.
• • For Step 1B, any female child who has experienced menarche.
• • Acute illness with or without fever (temperature \>38.0oC) is a temporary exclusion criterion. Enrollment may be postponed until 3 days after the illness has resolved.
• • Positive malaria test is a temporary exclusion criterion. Participant may be enrolled 3 days after completing treatment.
• • Any condition determined by the investigators to be likely to interfere with evaluation of the vaccine, to be a significant health risk to the participant, or to make it unlikely that the participant would complete the study