Salmonella Conjugates CVD 2000: Study of Responses to Vaccination With Trivalent Salmonella Conjugate Vaccine to Prevent Invasive Salmonella Disease

NCT05525546 | Completed Phase 1 FDA Drug

• 1 other identifier: HP-00099225
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Risk Reduction

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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).

  approximately six months

Study Arms (4)

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.

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.

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.

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.

Other: Placebo

Interventions

Trivalent Salmonella Conjugate Vaccine (TSCV) Full-Strength Formulation BIOLOGICAL

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.

Group A: Full-Strength Formulation

Trivalent Salmonella Conjugate Vaccine (TSCV) Half-Strength Formulation BIOLOGICAL

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.

Group B: Half-Strength Formulation

Trivalent Salmonella Conjugate Vaccine (TSCV) Dilutional Half-Strength Formulation BIOLOGICAL

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.

Group C: Dilutional Half-Strength Formulation

Placebo OTHER

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.

Group D: Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• \* 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.

You may not qualify if:

• 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).
• 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.
• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Pharmaron

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Myron M Levine, MD, DTPH

  University of Maryland, Baltimore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: August 15, 2022
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)