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| Name | Class |
|---|---|
| Rockefeller University | OTHER |
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This protocol is for a phase 1, randomized, single-blinded study to evaluate the safety and tolerability of a single 5 mcg dose of GLA-SE administered intramuscularly and GLA-AF administered subcutaneously. The second focus will be to detail the global immune response by measuring systemic cytokines, chemokines, and global gene regulation. The third focus will be to investigate the effects of GLA on the peripheral blood immune cells including monocytes and dendritic cells. The results of this trial will generate supportive human data to use GLA as an adjuvant in a dendritic cell-targeted vaccine strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLA-AF | Experimental | 5 mcg GLA-AF given as one subcutaneous injection. |
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| GLA-SE | Experimental | 5 mcg GLA-SE given as one intramuscular injection. |
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| EM060G (SE) | Experimental | EM060G (SE) given as one intramuscular injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLA-AF | Biological | Glucopyranosyl Lipid A (GLA) in an aqueous formulation (AF). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Local reactogenicity events and systemic reactogenicity events will be monitored for 28 days post injection.
Long term safety will be monitored by follow-up phone calls at 3 months, 6 months, and 1 year post injection. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Describe the global immune response by measuring systemic cytokines, chemokines and global gene regulation. Investigate the effects of GLA on the peripheral blood immune cells including monocytes and dendritic cells. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franco Piazza, MD, MPH | Access to Advanced Health Institute (AAHI) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rockefeller University | New York | New York | 10065 | United States |
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| ID | Term |
|---|---|
| C000592475 | GLA-AF adjuvant |
| C000608161 | glucopyranosyl lipid-A |
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| GLA-SE |
| Biological |
Glucopyranosyl Lipid A (GLA) in a stable oil-in-water emulsion (SE). |
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| EM060G (SE) | Biological | The same stable oil-in-water emulsion (SE), but without GLA. |
|