Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269295
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-12-22
Brief Title:
TY800 Dose Escalation Typhoid
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Dose Escalation In-Patient Phase III Study to Determine the Safety and Immunogenicity of Ty800 in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Typhoid fever is a generalized infection of the reticuloendothelial system spleen liver and bone marrow gut-associated lymphoid tissue and gall bladder caused by Salmonella enterica serovar Typhi S typhi Humans are the only known natural host and reservoir for S typhi Typhoid bacilli are transmitted by the fecal-oral route by contaminated drinking water or food The ideal typhoid vaccine would combine high levels of durable protective immunity with simplicity of administration and minimal reactogenicity The primary objective of this study is to assess the safety of Ty800 oral typhoid vaccine when administered as a single dose over a range of doses 5 x 107 5 x 108 and 5 x 109 cfu in healthy adult subjects compared to placebo The primary endpoint is safety of Ty800 at the dose levels administered compared to placebo as determined by absence of bacteremia absence of the diagnosis of typhoid fever as confirmed by a positive blood culture for the Ty800 vaccine organism and by verifying that the null phoPphoQ phenotype is retained by the isolated shed vaccine organism Safety variables will be assessed by the reported incidence of adverse events AE blood cultures and changes in vital signs physical examination and routine laboratory parameters over time at each vaccine dose level compared to placebo The secondary objectives of this study are to evaluate the immunogenicity of a single oral dose administration of Ty800 over a range of doses in healthy adult subjects to evaluate the Ty800 vaccine dose response by comparing the immunogenicity profiles of each dose level and to evaluate the shedding profile of Ty800 by determining the quantity and duration of shedding for each dose level The tertiary objectives of this study include evaluating in a substudy single nucleotide polymorphisms SNPs in candidate genes eg IL-8 and interferon gamma that may influence the immune response or persistent shedding of the vaccine organism and evaluating the induction of memory B cells in the vaccinated subjects This study is a randomized double-blind placebo-controlled dose escalation inpatient phase III clinical trial Three dose levels of Ty800 a vaccine will be evaluated and compared to placebo Prior to randomization and administration of study vaccine subjects will undergo screening evaluations Healthy subjects meeting study eligibility criteria will be admitted to an inpatient facility with appropriate isolation containment the day prior to randomization and they will remain in the unit for approximately 10 consecutive days Three cohorts of 18 volunteers representing 3 escalating doses of Ty800 typhoid vaccine will be challenged In each cohort 12 volunteers will receive Ty800 as a single oral dose and 6 volunteers will receive placebo Dose escalation will occur in a stepwise fashion and will be dependent upon the assessment of safety parameters and by meeting criteria for advancement to the next dose Participants will be involved in study related procedures for up to 7 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None