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| Name | Class |
|---|---|
| PT Etana Biotechnologies Indonesia | UNKNOWN |
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This is a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups (Group A and B). In each treatment group, 18 participants will be randomly assigned to receive either the investigational vaccine (Dose A or Dose B of Ad5-105K) or a placebo in a ratio of 2:1. The distribution of participant's gender and age should be balanced in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental vaccine group, Low dose | Experimental | 1 doses of Ad5-105K vaccine (0.1ml) on Day 0 |
|
| Placebo Group, Low dose | Placebo Comparator | 1 doses of placebo (0.1ml) on Day 0 |
|
| Experimental vaccine group, High dose | Active Comparator | 1 doses of Ad5-105K vaccine (0.2ml) on Day 0 |
|
| Placebo Group, High dose | Placebo Comparator | 1 doses of placebo (0.2ml) on Day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tuberculosis (TB) vaccine (Ad5-105K) | Biological | 1 doses of Ad5-105K vaccine (1 x 10^8 vp)) on Day 0, Nebulized Inhalation (IH) through mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited adverse events (AEs) | Within 7 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited AEs | Within 30 mins after vaccination | |
| Occurrence of unsolicited AEs | Within 28 days after vaccination | |
| Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erlina Burhan | Respiratory Programmatic Implementation and Research Institute & RSUP Persahabatan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rumah Sakit Islam Jakarta Cempaka Putih | Jakarta | Indonesia |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Placebo | Biological | 1 doses of placebo on Day 0, IH |
|
| Ad5-105K | Biological | 1 doses of Ad5-105K vaccine (2 x 10^8 vp)) on Day 0, IH |
|
| Placebo | Biological | 1 doses of placebo on Day 0, IH |
|
| Through study completion, an average of 6 months |
| Occurrence of abnormal hematology and chemistry laboratory assessments | On Day 3 after vaccination |
| Geometric mean titer (GMT) of anti-TB75K and anti-Ag85A IgG antibodies before vaccination | On Day 14 and Day 28 post-vaccination |
| Expression level of IFN-γ, TNF-α, IL-2, and IL-17 in 105K specific CD4+/CD8+ T cells evaluated by ICS | Before vaccination and on Day 14 and Day 28 post-vaccination |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |