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(MAC-0682) Poly ICLC in Healthy Volunteers


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A Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety and Immunogenicity of Poly ICLC (Hiltonol) in Healthy Volunteers

Principal Investigator:
Marina Caskey M.D.

Investigators:
Ralph M. Steinman M.D.
Sarah Schlesinger M.D.
Sarah Pollak RN
Saurabh Mehandru M.D.
Arlene Hurley ANP-BC
Niroshana Anandasabapathy M.D., Ph.D.

Contact Information:
Sarah Pollak, RN
1230 York Avenue
New York, NY 10065
Telephone: 212-327-7394
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
In 2010, at The Rockefeller University Hospital, we plan to do a vaccine study that builds on what we learn in this study that you are considering entering. Vaccines are important because they protect people from diseases. The vaccine we plan to test next year differs from previous vaccines in that it will deliver foreign protein directly to the cells to alert the body about invading viruses and bacteria. In order for the protein to be effective, in the vaccine study, it will be combined with a second component called poly ICLC (Hiltonol). Poly ICLC, which we will be testing in the study you are considering entering, enhances the body’s immune response. Although poly ICLC has been studied previously in humans we would like more information on the safety and overall response your body has to poly ICLC alone. What we learn about poly ICLC in this study will help us design the study we plan to do in 2010. Some of the study investigators will be involved in both studies, and some of those investigators and The Rockefeller University will gain a financial benefit if the vaccine studied in 2010 advances to a commercial product.



Detailed Description of Protocol:




What specifically makes a person eligible for the study?
You may be eligible to enter this study:



Gender:
Both

Age(s):
18-60

Children permitted to participate:
No

Potential Benefits.....




Compensation:
Compensation is provided.