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(SSC-0710) DCVax-001 Plus ICLC in Healthy Volunteers


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A Randomized, Placebo-controlled, Dose-escalating, Double-blinded Phase 1 Study to Evaluate Safety and Immunogenicity of Anti-DEC-205 Monoclonal Antibody (mab) Targeted HIV gag p24 Vaccine (DCVax-001) with Poly ICLC (Hiltonol) as Adjuvant in HIV-uninfected Healthy Volunteers

Principal Investigator:
Sarah Schlesinger M.D.

Investigators:
Sandhya Vasan M.D.
Christine Trumpfheller Ph.D.
Irina Shimeliovich M.D., Ph.D.
Sarah Pollak RN
Saurabh Mehandru M.D.
Arlene Hurley ANP-BC
Marina Caskey M.D.
Gaelle Breton MSc
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:
The global HIV epidemic continues to expand with over 33 million people infected worldwide. HIV stands for Human Immunodeficiency Virus, the virus that causes AIDS (Acquired Immune Deficiency Syndrome). The development of an effective vaccine against HIV is a priority to control this epidemic. Although several vaccines have been tested they have not succeeded in preventing HIV infection. A new approach will be required to design a vaccine that works. We aim to evaluate the safety and overall response your body has to a new vaccine after it is injected into your arm. The study will evaluate two components. The first component of the vaccine differs from previous vaccines in that it will deliver foreign protein made in a laboratory to mimic a small part of HIV directly to cells that protect the body from invading viruses. This vaccine does not contain anything derived from a live virus or a human blood product. The second component poly ICLC (Hiltonol) enhances the immune response.



Detailed Description of Protocol:
Approximately 45 volunteers will be enrolled in the study. 15 volunteers will be enrolled in each of the 3 vaccine dose groups. Within each vaccine dose group, each volunteer will be randomly assigned (like in a lottery) to receive either the vaccine (DCVax-001) we are testing together with poly ICLC, or poly ICLC alone, or will get injections which look the same but have no drug in them: these injections will be salt water (placebo). In each of the vaccine dose groups, 9 of 15 volunteers will receive the vaccine plus poly ICLC, 3 of 15 will receive poly ICLC alone and 3 will receive placebo. You will receive these injections 3 times. The first injection will be at the start of the study and then 4 and 12 weeks later. Volunteers randomized to receive active vaccine in the first dose group will receive 0.3 mg of the vaccine with 1.6 mg of poly ICLC. The second group will receive 1 mg of the vaccine with 1.6 mg of poly ICLC and the third group will receive 3 mg of the vaccine with1.6 mg of poly ICLC. Volunteers in all 3 vaccine dose groups who are randomized to receive poly ICLC alone will receive 1.6 mg of poly ICLC. The researchers and you will not know if you are getting the drug or not, but that information will be available if needed. This is the best way to know if the drug works or not.



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

- In good health
- HIV negative

Gender:
Both

Age(s):
18-60

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 and HIV status. Instead, others may benefit in the future from what we learn from this study.



Compensation:
Compensation will be provided.