Study to Evaluate the Safety and Immunogenicity of Poly ICLC (Hiltonol) in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT01012700 |
Recruitment Status :
Completed
First Posted : November 13, 2009
Last Update Posted : March 28, 2014
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Condition or disease | Intervention/treatment | Phase |
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Healthy Volunteers | Drug: Hiltonol (poly ICLC) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | A Randomized, Placebo-controlled, Phase I Study to Evaluate the Safety and Immunogenicity of Poly ICLC (Hiltonol) in Healthy Volunteers |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | April 2010 |
Arm | Intervention/treatment |
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No Intervention: intranasal or IV
Each study group consists of 12 volunteers randomized in a 2:1 ratio to receive poly ICLC or placebo: in group 1, 8 volunteers will be administered poly ICLC and 4 volunteers will be administered placebo, subcutaneously; and in group 2, 8 volunteers will be administered poly ICLC and 4 volunteers will be administered placebo, intranasally. A total of up to 24 volunteers will be enrolled in the study.
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Active Comparator: Hiltonol (poly ICLC)
Each study group consists of 12 volunteers randomized in a 2:1 ratio to receive poly ICLC or placebo: in group 1, 8 volunteers will be administered poly ICLC and 4 volunteers will be administered placebo, subcutaneously; and in group 2, 8 volunteers will be administered poly ICLC and 4 volunteers will be administered placebo, intranasally. A total of up to 24 volunteers will be enrolled in the study.
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Drug: Hiltonol (poly ICLC)
2 mg administered subcutaneously or intranasally to healthy volunteers |
- To evaluate the safety of a single dose of 2mg of poly ICLC (Hiltonol) administered to healthy volunteers. [ Time Frame: 12 months ]
- To evaluate the innate immune responses to poly ICLC in multiple blood cell types in addition to whole PBMCs and three different subsets of dendritic cells after administration to healthy volunteers at different timepoints of administration. [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy adult males and females, as assessed by a medical history, physical exam, and laboratory tests
- Age of at least 18 years on the day of screening and no greater than 60 years at time of drug/placebo administration
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 4 weeks)
- In the opinion of the principal investigator or designee, has understood the information provided. Written informed consent needs to be given before any study-related procedures are performed
- Willing to undergo HIV testing and counseling, and receive HIV test results
- If a sexually active male, willing to use an effective method of contraception (condoms, anatomical sterility) throughout the study period and will be advised not to get his partner pregnant for 6 weeks after study drug administration
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Females of child-bearing potential must agree to use one of the following methods of contraception for 2 weeks prior to date of screening evaluation through 6 weeks after study drug administration:
- Be surgically sterile Be abstinent (or willing to be)
- Use oral contraceptives, or other form of hormonal birth control including hormonal vaginal rings or transdermal patches
- Use an intra-uterine device (IUD)
- Use (by ensuring her male partner(s) uses) barrier contraception (condom) with spermicide
- Any other equivalent (as judged by the investigative team) methods of contraception
Exclusion Criteria:
- Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the trial physician within the last 6 months
- Confirmed HIV-1 or HIV-2 infection
- A medical history that includes any chronic medical problem that requires daily topical nasal medications, prior nasal or sinus surgery (including trans-nasal approaches of other organs such as pituitary, allergic rhinitis, chronic sinusitis, or any other nasal inflammatory disease that requires daily intranasal or oral medication)
- A medical history that includes any chronic pulmonary conditions including but not limited to asthma, chronic obstructive pulmonary disease and chronic bronchitis
- Any clinically significant acute or chronic medical conditions requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation
- Any laboratory value outside of reference range, with the exception of any non-clinically significant Grade 1 elevations of liver function tests (AST, ALT, direct/total bilirubin), CBC, as determined by the Principal Investigator or her designee
- Confirmed diagnosis of hepatitis B (surface antigen, HbsAg); hepatitis C (HCV antibodies) or active syphilis
- If female, pregnant, planning a pregnancy during the trial period or lactating
- Receipt of a live attenuated vaccine within 30 days or other vaccine within 14 days of poly ICLC administration
- Receipt of blood transfusion or blood products 6 months prior to drug administration

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): NCT01012700
United States, New York | |
The Rockefeller University | |
New York, New York, United States, 10065 |
Principal Investigator: | Marina Caskey, MD | Instructor in Clinical Investigation |
Responsible Party: | Rockefeller University |
ClinicalTrials.gov Identifier: | NCT01012700 |
Other Study ID Numbers: |
MAC-0682 |
First Posted: | November 13, 2009 Key Record Dates |
Last Update Posted: | March 28, 2014 |
Last Verified: | March 2014 |
Poly ICLC Interferon Inducers Immunologic Factors Physiological Effects of Drugs |