A Phase 1 interventional study of AERAS-404 and Placebo in Tuberculosis, sponsored by Aeras. Completed at 1 site in Finland. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-17.
Sponsored by Aeras · Phase 1, Interventional, and Prevention
This Phase I study will be conducted as a randomized, double-blind, dose-escalation study in five groups of healthy adult male and female subjects who are BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection. Since BCG-vaccinated individuals are the target population for which AERAS 404 might be indicated, AERAS 404 will be administered to individuals already vaccinated with BCG
Sixty subjects will be sequentially enrolled into one of five study groups (i.e., Group 1, Group 2, Group 3, Group 4, or Group 5) with 10 subjects per group in Groups 1-4 and 20 subjects in Group 5. Within each study group, subjects will be randomized to a treatment assignment of either AERAS-404 or placebo control at a ratio of 4:1 (Groups 1-4) or two different dose amounts of AERAS-404 or placebo control at a ratio of 9:9:2 (Group 5) administered by intramuscular injection on Study Day 0 and Study Day 56. The principal investigator will determine an appropriate interval between the vaccinations such that the entire group is not dosed at the same time. All subjects will receive the same treatment on Study Day 0 as they receive on Study Day 56. 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
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 60 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.
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Exclusion Criteria:
H4 Antigen at 5 ug IC31 Adjuvant 500 nmol 2 doses at Study days 0 and 56
Biological: AERAS-404 · Biological: Placebo
H4 Antigen at 15 ug IC31 Adjuvant 500 nmol 2 doses at Study days 0 and 56
Biological: AERAS-404 · Biological: Placebo
H4 Antigen at 50 ug IC31 Adjuvant 500 nmol 2 doses at Study days 0 and 56
Biological: AERAS-404 · Biological: Placebo
H4 Antigen at 150 ug IC31 Adjuvant 500 nmol 2 doses at Study days 0 and 56
Biological: AERAS-404 · Biological: Placebo
H4 Antigen at 5 ug or 15 ug IC31 Adjuvant 100 nmol Placebo - sterile buffer 2 doses at Study days 0 and 56
Biological: AERAS-404 · Biological: Placebo
AERAS-404 is comprised of the H4 antigen, a fusion protein of Mycobacterium tuberculosis antigens 85B and TB10.4; and IC31 adjuvant, a combination of a leucine-rich peptide and a synthetic oligonucleotide.
Also known as: H4
Sterile buffer containing 10 mmol Tris and 169 mmol of NaCl in 0.8 mL of aqueous solution. This is the identical buffer solution in which H4 and IC31 are formulated.
Also known as: Sterile Buffer
Safety profile of two injections of AERAS 404 at different dose levels of antigen and adjuvant.
Serious Adverse Events (SAE) will be collected on subjects throughout their participation in the study. Solicited and unsolicited adverse events are captured 28 days post each vaccination. The safety profile of AERAS-404 will be summarized by treatment regimen. The number (percentage) of subjects with adverse events will be summarized by MedDRA system organ class (SOC), and preferred term (PT). Additional summaries will present the number (percentage) of subjects with adverse events by severity and by relationship to study vaccine.
Time frame: Total duration of study follow up for all subjects is 182 days.
Immunogenicity of two injections of AERAS 404 at different dose levels of antigen and adjuvant.
Intracellular cytokine staining will be used to assess immunogenicity. Immune response based on percentages of CD4+ and CD8+ T cells that produced one, two, or three cytokines (IFN-γ, TNF-α, and/or IL-2) in response to stimulation with one of 2 antigenic peptide pools (Ag85B and TB10.4) derived from and representing the entire amino acid sequences of the mycobacterial antigens Ag85B and TB10.4, respectively.
Time frame: Immunogenicity was evaluated from blood collected at Study Days 0, 7, 14, 28, 56, 63, 70, 84, and 182. For all subjects, a QuantiFERON-TB Gold test was performed during screening and at Study Day 182
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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