TY800 Dose Escalation (Typhoid)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to determine whether a new vaccine for typhoid fever is safe and effective. This study will also look at what effects (good and bad) this new vaccine, Ty800, has on the volunteers. The study will determine the highest dose of Ty800 that can be given without causing severe side effects. About 54 healthy males and females, ages 18-45 inclusive, in the Cincinnati metropolitan area will be enrolled in this study. They will be in the study for approximately 7 months, which includes a one month screening period, study product administration on Day 0, a 10-day hospital stay, an outpatient period on Days 9-28 with 4 follow-up visits, and safety follow-up phone calls at 2 and 6 months after hospital discharge. Researchers hope that this trial will help produce a vaccine that combines a high level of durable protective immunity with simplicity of administration and minimal reaction to the vaccine.

Research Team

Eligibility Criteria

Inclusion Criteria

Healthy men or women, aged 18 to 45 years, inclusive.

Provide voluntary written informed consent prior to undergoing any study specific screening procedures.

Must be willing to remain in the inpatient study unit for at least 10 days.

Treatment Details

Interventions

• Placebo ()
• Ty800 (Vaccine)

Participant Groups

Group I: Cohort 3: Arm 1 Experimental Treatment 1 Intervention

12 subjects to receive vaccine dose 3: 5 X 10\^9 cfu.

Group II: Cohort 2: Arm 1 Experimental Treatment 1 Intervention

12 subjects to receive vaccine dose 2: 5 X 10\^8 cfu.

Group III: Cohort 1: Arm 1 Experimental Treatment 1 Intervention

12 subjects to receive vaccine dose 1: 5 X 10\^7 cfu.

Group IV: Cohort 1: Arm 2 Placebo Group 1 Intervention

6 subjects to receive placebo.

Group V: Cohort 2: Arm 2 Placebo Group 1 Intervention

6 subjects to receive placebo.

Group VI: Cohort 3: Arm 2 Placebo Group 1 Intervention

6 subjects to receive placebo.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Dr. Jeanne Marrazzo

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Executive Officer since 2023

MD, MPH

Dr. H. Clifford Lane

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Medical Officer

MD