Polyinosinic-Polycytidylic Acid-poly-L-lysine Carboxymethylcellulose (Poly-ICLC) in Healthy Volunteers
|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.
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|