The Effects of GLA (5 mcg) on Human Volunteers
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|ClinicalTrials.gov Identifier: NCT01864876|
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : February 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Biological: GLA-AF Biological: GLA-SE Biological: EM060G (SE)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||A Randomized, Single-Blinded Phase 1 Study to Evaluate the Safety and Immunogenicity of a Single Administration of 5 mcg GLA in Healthy Volunteers|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
5 mcg GLA-AF given as one subcutaneous injection.
Glucopyranosyl Lipid A (GLA) in an aqueous formulation (AF).
5 mcg GLA-SE given as one intramuscular injection.
Glucopyranosyl Lipid A (GLA) in a stable oil-in-water emulsion (SE).
Experimental: EM060G (SE)
EM060G (SE) given as one intramuscular injection.
Biological: EM060G (SE)
The same stable oil-in-water emulsion (SE), but without GLA.
- Safety [ Time Frame: 1 year ]
Local reactogenicity events and systemic reactogenicity events will be monitored for 28 days post injection.
- Local reactogenicity events include tenderness, erythema, skin discoloration, edema, vesicle formation or ulceration, induration, pruritus, formation of a crust or scab, or other.
- Systemic reactogenicity events include fever, chills, headache, nausea, vomiting, malaise, myalgia, arthralgia, and rash.
Long term safety will be monitored by follow-up phone calls at 3 months, 6 months, and 1 year post injection.
- Immunogenicity [ Time Frame: 28 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864876
|United States, New York|
|New York, New York, United States, 10065|
|Study Director:||Franco Piazza, MD, MPH||IDRI|