Evaluating a new Salmonella vaccine for different age groups
Age-descending, Randomized, Placebo-controlled Phase 2 Trial in Three Sites in Sub-Saharan Africa to Assess the Safety and Immunogenicity of a Parenteral Trivalent Salmonella (S. Enteritidis/S. Typhimurium/S. Typhi Vi) Conjugate Vaccine (TSCV) Versus Placebo
This study is testing a new Salmonella vaccine to see if it is safe and effective for people of different ages, from adults down to infants.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 12 Weeks to 35 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Bamako) |
| Trial ID | NCT05784701 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to assess the safety and immunogenicity of a Trivalent Salmonella Conjugate Vaccine (TSCV) through a randomized, placebo-controlled approach. The study will be conducted in an age-descending manner, starting with adults and progressing to children, toddlers, and infants. Participants will receive either a full-strength or half-strength dose of the vaccine or a placebo, with follow-up assessments conducted over a six-month period. The trial will involve multiple steps, each focusing on different age groups, to ensure comprehensive safety and efficacy data is collected.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals ranging from adults to infants, specifically those within the specified age groups for each trial step.
Not a fit: Patients with underlying health conditions or those who do not meet the age and residency criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could significantly reduce the incidence of Salmonella infections in various age groups.
How similar studies have performed: Other studies have shown promise in developing vaccines for Salmonella, but this specific approach with a trivalent formulation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bamako
- Centre for Vaccine Development (CVD-Mali) — Bamako, Mali (Recruiting)
Study contacts
- Principal investigator: Miligritos Tapia, MD — University of Maryland Center for Vaccine Development
- Study coordinator: Fleesie Hubbard
- Email: fhubbard@som.umaryland.edu
- Phone: 410-706-0850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.