Trivalent Salmonella Conjugate Vaccine (TSCV)

NCT05784701 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HP-00103997
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trivalent Salmonella Conjugate Vaccine (TSCV)

Keywords

S. Enteritidis; S. Typhimurium; S. Typhi Vi; Trivalent Salmonella Conjugate Vaccine (TSCV)

Outcome Measures

Primary Outcomes (17)

• Safety and reactogenicity of Full-strength and Half-strength TSCV

  The proportion of participants in each product group and within each age group who develop adverse events (AEs) in the first 30 minutes after parenteral immunization

  first 30 minutes after parenteral immunization

• Safety and reactogenicity of Full-strength and Half-strength TSCV

  The proportion of participants in each product group and within each age group who develop adverse events (AEs) in the 7 days post-vaccination.

  over 7 days post-vaccination.

• Safety and reactogenicity of Full-strength and Half-strength TSCV

  The proportion of participants who experience AEs through Day 29 of follow-up post-vaccination.

  through Day 29 of follow-up post-vaccination

• Safety and reactogenicity of Full-strength and Half-strength TSCV

  The proportion of participants who experience Serious Adverse Events through their participation in the study.

  Through Day 366 of follow-up post vaccination

• Non-inferiority analysis: immunogenicity of Full-strength vs. Half-strength TSCV

  Serum IgG anti-COPS antibodies (to both S. Enteritidis and S. Typhimurium antigens)

  Through day 29 post vaccination

• Non-inferiority analysis: immunogenicity of Full-strength vs. Half-strength TSCV

  Serum IgG anti-Vi antibodies

  Through day 29 post vaccination

• Safety and reactogenicity after primary dose of TSCV and after booster dose of TSCV or Typbar-TCV™ [At each booster age group (9, 12, or 15-17 mo. of age)]

  The proportion of participants in each product group who develop adverse events (AEs) in 7 days post-vaccination.

  over 7 days post-vaccination.

• Safety and reactogenicity after primary dose of TSCV and after booster dose of TSCV or Typbar-TCV™ [At each booster age group (9, 12, or 15-17 mo. of age)]

  The proportion of participants who experience AEs through Day 29 of follow-up after each vaccination.

  through Day 29 of follow-up after each vaccination.

• Safety and reactogenicity after primary dose of TSCV and after booster dose of TSCV or Typbar-TCV™ [At each booster age group (9, 12, or 15-17 mo. of age)]

  The proportion of participants who experience Serious Adverse Events through their participation in the study.

  Until the end of the participant study period - 6 months to 1 year post vaccination

• Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]

  The rates of seroconversion of serum IgG anti-COPS at each booster age group

  At day 29 post booster vaccination

• Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]

  The geometric mean titers of serum IgG anti-COPS at each booster age group

  At day 29 post booster vaccination

• Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]

  The increases in geometric mean-fold titers from day 1 to 29 of serum IgG anti-COPS at each booster age group

  At day 29 post booster vaccination

• Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]

  The rates of persisting seroconversion (titers remaining \> 4-fold above Day 1) of serum IgG anti-COPS at each booster age group

  At day 29 post booster vaccination

• Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]

  The rates of seroconversion of serum IgG anti-Vi at each booster age group

  At day 29 post booster vaccination

• Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]

  The geometric mean titers of serum IgG anti-Vi at each booster age group

  At day 29 post booster vaccination

• Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]

  The increases in geometric mean-fold titers from day 1 to 29 of serum IgG anti-Vi at each booster age group

  At day 29 post booster vaccination

• Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]

  The rates of persisting seroconversion (titers remaining \> 4-fold above Day 1) of serum IgG anti-Vi at each booster age group

  At day 29 post booster vaccination

Study Arms (4)

TSCV (Full-strength)

ACTIVE COMPARATOR

Full-strength GMP formulation of Trivalent Salmonella Conjugate Vaccine (TSCV)

Drug: TSCV (Full-strength)

TSCV (Half-strength)

ACTIVE COMPARATOR

Half-strength GMP formulation of TSCV

Drug: TSCV (Half-strength)

Typbar-TCV

ACTIVE COMPARATOR

Licensed Monovalent Typbar-TCV

Drug: Typbar-TCV

Placebo

PLACEBO COMPARATOR

PBS

Drug: Placebo

Interventions

TSCV (Full-strength) DRUG

TSCV (Full-strength)

TSCV (Full-strength)

TSCV (Half-strength) DRUG

TSCV (Half-strength)

TSCV (Half-strength)

Typbar-TCV DRUG

Typbar-TCV

Typbar-TCV

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 12 Weeks - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy individuals, female or male
• Age (all age ranges are inclusive)
• Step 1A: Adults 20-35 years of age
• Step 1B: Children, 5-9 years of age
• Step 1 C: Pre-school children, 24-59 mos. of age
• Step 1D: Older toddlers, 16-23 months of age
• Step 2A: Young toddlers, 12-16 months of age
• Step 2B: Older infants, 8-11 months of age
• Step 3: Young infants,12-14 weeks of age OR 16-18 weeks of age
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Bharat Biotech International: collaborator
• Wellcome Trust: collaborator

Study Sites (1)

Centre for Vaccine Development (CVD-Mali)

Bamako, Mali

RECRUITING

Study Officials

• Miligritos Tapia, MD

  University of Maryland Center for Vaccine Development

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fleesie Hubbard

CONTACT

410-706-0850; fhubbard@som.umaryland.edu

Alyson Kwon

CONTACT

akwon@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 27, 2023
• Study Start: April 5, 2023
• Primary Completion (Estimated): January 5, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)