The Effects of GLA (5 mcg) on Human Volunteers

NCT ID: NCT01864876

Last Updated: 2014-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-12-31

Brief Summary

This protocol is for a phase 1, randomized, single-blinded study to evaluate the safety and tolerability of a single 5 mcg dose of GLA-SE administered intramuscularly and GLA-AF administered subcutaneously. The second focus will be to detail the global immune response by measuring systemic cytokines, chemokines, and global gene regulation. The third focus will be to investigate the effects of GLA on the peripheral blood immune cells including monocytes and dendritic cells. The results of this trial will generate supportive human data to use GLA as an adjuvant in a dendritic cell-targeted vaccine strategy.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

GLA-AF

5 mcg GLA-AF given as one subcutaneous injection.

Group Type: EXPERIMENTAL

GLA-AF

Intervention Type: BIOLOGICAL

Glucopyranosyl Lipid A (GLA) in an aqueous formulation (AF).

GLA-SE

5 mcg GLA-SE given as one intramuscular injection.

Group Type: EXPERIMENTAL

GLA-SE

Intervention Type: BIOLOGICAL

Glucopyranosyl Lipid A (GLA) in a stable oil-in-water emulsion (SE).

EM060G (SE)

EM060G (SE) given as one intramuscular injection.

Group Type: EXPERIMENTAL

EM060G (SE)

Intervention Type: BIOLOGICAL

The same stable oil-in-water emulsion (SE), but without GLA.

Interventions

GLA-AF

Glucopyranosyl Lipid A (GLA) in an aqueous formulation (AF).

Intervention Type: BIOLOGICAL

GLA-SE

Glucopyranosyl Lipid A (GLA) in a stable oil-in-water emulsion (SE).

Intervention Type: BIOLOGICAL

EM060G (SE)

The same stable oil-in-water emulsion (SE), but without GLA.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Healthy adult males and females, as assessed by a medical history, physical exam,and laboratory tests;

2. Age of at least 18 years of age on the day of screening and no greater than 50 years at time of administration;

3. 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);

4. Willing to undergo HIV testing and counseling and receive HIV test results;

5. If a female of child bearing potential, must be willing to use two effective methods of contraception (combined oral contraceptive pill; injectable contraceptive; diaphragm; Intra Uterine Device (IUD); condoms; anatomical sterility in self or partner) until 6 weeks after study drug administration. If a sexually active male, must be willing to use two effective methods of contraception (such as condoms, anatomical sterility) from screening until 6 weeks after study drug administration (same as above) and will be advised not to get his partner(s) pregnant during this time.

Exclusion Criteria

1. Positive for hepatitis B surface antigen, positive for hepatitis C antibodies, or active syphilis infection based on clinical evaluation;

2. Confirmed HIV-1 or HIV-2 infection;

3. Any clinically significant abnormality on medical history or physical examination including history of immunodeficiency or autoimmune disease;

4. Any use of systemic corticosteroids immunosuppressive anticancer medications;

5. Any clinically significant acute or chronic medical condition 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;

6. Any laboratory value outside of reference range other than CRP, with the exception of any non-clinically significant Grade I elevations of liver function tests (AST, ALT, direct/total bilirubin), electrolytes (Na, K, Cl, CO2), CBC, urinalysis as determined by the Principal Investigator or his designee.

7. Within the 12 months prior to enrollment, the subject self reports excessive daily alcohol use, frequent binge drinking or chronic marijuana abuse (defined as greater than 2 times a week) or any other use of illicit drugs;

8. If female, pregnant, planning a pregnancy during the trial period, or lactating;

9. Receipt of a live attenuated vaccine within 30 days or other vaccine within 14 days prior to study drug;

10. Prior receipt of GLA in another research study;

11. Participation in another clinical study of an investigational product currently or within past 16 weeks, or expected participation during this study;

12. In the opinion of the investigator, unlikely to comply with protocol due to medical, social or psychiatric reasons;

13. Allergy to eggs

14. A glomerular filtration rate that is less than 60 mL/min/1.73 m2 as calculated by study team based on laboratory creatinine values.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rockefeller University

OTHER

Sponsor Role: collaborator

Access to Advanced Health Institute (AAHI)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franco Piazza, MD, MPH

Role: STUDY_DIRECTOR

Access to Advanced Health Institute (AAHI)

Locations

Rockefeller University

New York, New York, United States

Countries

United States

Other Identifiers

MCA-0784

Identifier Type: -

Identifier Source: org_study_id