Polyinosinic-Polycytidylic Acid-poly-L-lysine Carboxymethylcellulose (Poly-ICLC) in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT01299662|
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : August 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Poly ICLC||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Study to Evaluate Innate Immune Responses Induced by a Pattern Recognition Receptor Agonist, Poly-ICLC (Hiltonol), in Healthy Volunteers|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Experimental: Poly ICLC
One 1.6 mg subcutaneous injection of the adjuvant, poly ICLC, in the upper arm.
Drug: Poly ICLC
One 1.6 mg subcutaneous injection of the study drug, poly ICLC in the upper arm.
- To evaluate the innate immune responses to poly ICLC in different blood cell types, including three subsets of dendritic cells after subcutaneous administration to healthy volunteers. [ Time Frame: 2 years ]
The variables to be assessed include:
- Transcriptional arrays in whole PBMCs and in 8 subsets of blood leukocytes (naïve and memory T, NK, B, monocytes and three different subsets of dendritic cells (BDCA1+, BDCA3+ and BDCA2+ plasmacytoid DCs) following s.c. administration of poly ICLC.
- Flow cytometric analysis of activation markers in different subsets of blood leukocytes.
- Measurement of cytokines in the serum and/or plasma following s.c. administration of poly ICLC.
- To evaluate the reproducibility of innate immune responses in whole PBMCs after a second dose of poly ICLC, in volunteers who participated in protocol MAC-682 and now return to participate in this proposed study. [ Time Frame: 2 years ]
The following variable will be assessed:
- Transcriptional analysis of whole PBMC samples at different timepoints following the first dose and the second dose of poly ICLC in volunteers who participated in protocol MAC-682 and are now returning to participate in this proposed study.
- To evaluate innate immune responses to poly ICLC at the injection site. [ Time Frame: 2 years ]
The following will be assessed:
- Routine histology and immunohistochemistry to evaluate cellular infiltrates following subcutaneous injection of poly ICLC.
- Transcriptional analysis of skin samples from study drug injection site and from a non-lesional site of skin.
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): NCT01299662
|United States, New York|
|The Rockefeller University|
|New York, New York, United States, 10065|
|Principal Investigator:||Marina Caskey, MD||The Rockefeller University|