Trivalent Salmonella Conjugate Vaccine (TSCV)

• Status: Not yet recruiting
• Trial end date: 2026-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This is an age-descending, randomized, placebo-controlled trial that will evaluate the safety and immunogenicity of a Trivalent Salmonella conjugate vaccine (TSCV). The trial will proceed from adults, to children, to toddlers, and then to infants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland, Baltimore
• Collaborators: Bharat Biotech International; Wellcome Trust

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