A Phase 1 interventional study of AERAS-404 and Placebo in Tuberculosis, sponsored by Aeras. Completed at 1 site in Sweden. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-19.
Sponsored by Aeras · Phase 1, Interventional, and Prevention
Phase I, randomized, double blinded, Placebo-controlled, immunogenicity and dose-range finding study of AERAS-404 in Bacille Calmette-Guerin (BCG) healthy adult male and sterile females.
This ia a Phase I, randomized, placebo-controlled, double-blind study in three groups of healthy adult males or sterile females who are BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection.
Sixty-four subjects assigned to one of eight treatment groups to receive one of four different antigen/adjuvant combinations of study vaccine, or placebo control. Within each study group, subjects will be randomized to receive either a single-dose antigen/adjuvant regimen of study vaccine (vaccination with study vaccine on Study Day 0 followed by vaccination with placebo control on Study Day 56) or a two-dose antigen/adjuvant regimen of study vaccine (vaccination with study vaccine on Study Days 0 and 56).
All subjects will be followed for safety and immunogenicity evaluations for 182 days.
The sample sizes specified for each study group were selected because they are judged to be adequate for preliminary safety and immunogenicity evaluations for a Phase I study rather than for statistical reasons. If no SAE are observed among 56 subjects receiving active study vaccine, an approximation to the upper 95% confidence bound on the rate of SAE occurrence would be 5.4%.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 64 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Aeras is the lead sponsor of 22 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 dose
Biological: AERAS-404 · Biological: Placebo
1 dose
Biological: AERAS-404 · Biological: Placebo
2 dose
Biological: AERAS-404 · Biological: Placebo
1 dose
Biological: AERAS-404 · Biological: Placebo
1 dose
Biological: AERAS-404 · Biological: Placebo
2 dose
Biological: AERAS-404 · Biological: Placebo
2 dose placebo
Biological: Placebo
2 dose
Biological: AERAS-404 · Biological: Placebo
AERAS 404 (H4:IC31) contains a fusion protein of 2 mycobacterial antigens (Ag85B and TB 10.4) formulated in IC31 adjuvant.
Also known as: H4
Tris buffer saline consisting (10mM Tris and 169mM NaCI at pH7.4)
Also known as: Tris Buffered saline
Evaluate the safety of one or two injections of two AERAS 404 antigen amounts administered with three different amounts of adjuvant
Serious adverse events (SAE) will be collected on subjects throughout their participation in the study. Solicited and unsolicited AEs will be collected through 28 days after each vaccination.The safety profile of the different antigen/adjuvant treatment regimens will be described. Listings will be provided for all subjects with serious adverse events (SAE). All adverse events and clinically relevant laboratory results will be summarized across time points to examine the relationship between treatment regimens (i.e., number of doses and level of antigen/adjuvant) and key safety endpoints including number (percentage) of solicited and spontaneous adverse events and number (percentage) of subjects with newly abnormal post-vaccination laboratory values based on predefined toxicity criteria. Adverse events will also be summarized by severity and relationship to study vaccine by treatment regimen.
Time frame: All subjects will be followed for safety and immunogenicity evaluations for 182 days. A total of eleven clinic visits are planned (excluding screening) for all subjects
Evaluate the immunogenicity of one or two injections of two AERAS 404 antigen amounts administered with three different amounts of adjuvant.
Assessment of immune response will be based on the percentage of CD4 and CD8 T cells producing any of three cytokines (interferon gamma, IFN-γ; tumor necrosis factor alpha, TNF-α; and/or interleukin-2, IL-2) or any combination of these three cytokines simultaneously in response to stimulation with two the antigenic peptide pools contains 85B and TB10.4 representing the entire amino acid sequences of mycobacterial antigens Ag85B and TB10.4, respectively. Responses will be measured by flow cytometry using a qualified intracellular cytokine staining (ICS) assay
Time frame: all subjects will have immunology samples taken at 9 time points over 182 days
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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