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(MCA-0784) Phase 1 Study to Evaluate the Safety and Immunogenicity of a Single Administration of 5µg GLA in Healthy Volunteers


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A Randomized, Single-Blinded Phase 1 Study to Evaluate the Safety and Immunogenicity of a Single Administration of 5µg GLA in Healthy Volunteers

Principal Investigator:
Marina Caskey M.D.

Investigators:
Christine Trumpfheller Ph.D.
Sarah Schlesinger M.D.
Maggi Pack PhD
Arlene Hurley ANP-BC
Noreen Buckely MS, APRN-BC
Gaelle Breton MSc
Niroshana Anandasabapathy M.D., Ph.D.

Contact Information:
Clinical Research Support Office
The Rockefeller University Hospital
1230 York Avenue
New York, NY 10065
Telephone: 1-800-RUCARES
Alt. Telephone: 1-800-782-2737
Email: RUCARES@Rockefeller.edu
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
The immune system protects the body from invading substances. In this study we want to learn more about a drug called Glucopyranosyl Lipid A (GLA) and how it works to boost the immune system. GLA is a drug used in combination with vaccines to make them work better, and is not used to treat a condition on its own. Although GLA has been studied previously in humans with a flu vaccine, we would like to examine how your body will respond to GLA by itself. What we learn about GLA in this study will help us design future vaccine trials.



Detailed Description of Protocol:
If you join the research study, you will take part for about 6 weeks. The research study as a whole will last about three years. About 17 people will take part in the research study at The Rockefeller University Hospital.

If you qualify and decide to join this study, you will be put in one of three groups. One group will receive the investigational drug we want to test, mixed in an oil suspension, another group will receive the oil suspension alone and the third group will receive the investigational drug alone. Which group you end up in is determined by chance.

There are 5 study visits over a 4 week period as well as three follow up calls over 1 year.



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

- Healthy (must be HIV negative)
- Cannot have an allergy to eggs
- Cannot have receivd GLA in previous research studies


Gender:
Both

Age(s):
18-50

Children permitted to participate:
No

Potential Benefits.....
There will be no benefit to you other than receiving physical exams and getting information about your general health. Instead, others may benefit in the future from what we learn from this study.



Compensation:
Compensation for participation is provided.