Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00326443
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2006-05-12
Brief Title:
CVD 909 Vi Prime Boost Study
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase I Randomized Double-Blind Heterologous Prime-Boost Study of the Safety and Immunogenicity of Vi Polysaccharide Typhoid Vaccine After Priming by Live Attenuated Oral Vi Salmonella Typhi Strain CVD 909
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 see if giving a typhoid vaccine by mouth an experimental vaccine CVD 909 before giving a vaccine shot Typhim Vi will result in a better immune response than giving Typhim Vi vaccine by itself Another purpose is to see whether CVD 909 is safe Typhim Vi has been shown to be safe and effective in preventing typhoid fever in older children and adults but it does not work in children under age 2 Scientists at the University of Maryland think that young children could respond to Typhim Vi if they were given a dose of the other typhoid vaccine by mouth before they are given the Typhim Vi shot Twenty-eight healthy adult volunteers ages 18-40 years will take part in this study Study participation will last for up to 63 weeks but most of the study visits will be in the first 6 weeks Blood samples will be collected approximately 13 times Four stool samples will be collected Some volunteers may be followed for an additional 4 years
Detailed Description:
This is a phase I randomized double-blind heterologous prime-boost study of the safety and immunogenicity of Vi polysaccharide typhoid vaccine after priming by live attenuated oral Vi Salmonella Typhi strain CVD 909 The primary study objective is to determine the phase 1 safety of the prime-boost regimen of priming with CVD 909 a live attenuated Vi S Typhi strain followed by boosting with licensed parenteral Vi polysaccharide vaccine in healthy adult volunteers The secondary objective is to compare the immunogenicity of licensed parenteral Vi polysaccharide vaccine in volunteers primed with a single oral dose of CVD 909 and in volunteers who are not primed with the oral vaccine The outcome measures of interest are the seroconversion rate and titer of serum IgG anti-Vi antibodies the timing of development and longevity of serum anti-Vi antibodies the subclasses and avidity of antibodies developed and the memory B and T cell responses elicited The following immunologic outcome measures will be sought rate and timing of seroconversion in each study arm after receiving Vi polysaccharide and analysis of immunoglobulin subclasses and avidity This will assess the presence of priming and the rapidity of the anamnestic response A successful priming would accelerate the response to the boost Day 7 after Vi vaccine and this response is expected to be more balanced inducing both Th1Th2-type immunity evidenced by the induction of both IgG1 and IgG2 geometric mean titer GMT of serum IgG anti-Vi antibodies on Days 7 14 21 and 35 post-Vi Days 28 35 42 and 84 of the study This will assess magnitude of response another measure of priming GMT of serum IgG Vi antibody in each study arm at multiple later time points up to 1 year after receiving parenteral Vi week 55 of the study This will assess the quality and duration of the antibodies and peripheral blood mononuclear cells will be collected to measure cytokine production and cytotoxic T lymphocyte CTL activity as well as the induction and maintenance of B and T cell memory responses and homing potential of antibody secreting cells ASC and T cells depending on cell numbers Twenty-eight healthy adult volunteers 18-40 years of age and from the Baltimore community will be recruited to participate in this study which will be conducted at the Center for Vaccine Development CVD University of Maryland School of Medicine The volunteers will be randomized to receive either 5x109 colony forming units of CVD 909 with buffer or buffer placebo alone Three weeks later all volunteers will receive 25 micrograms 05 ml of licensed purified Vi polysaccharide vaccine by the intramuscular route Blood for serum and antibody secreting cell responses to Vi S Typhi LPS and O antigen will be drawn before and after the Vi boost The patient participation duration is up to 63 weeks with the option for prolonged immunologic follow-up for 4 additional years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Typhoid CVD 36000 | None | None | None |