Phase 2
Completed N=25
Safety, Tolerability and Immune Response to LC002, an Experimental Therapeutic Vaccine, in Adults Receiving HAART
Source: ClinicalTrials.gov NCT00270205 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: Percent of Participants With Primary Safety Endpoint — 0; 0; 0; 0 percentage of participants
Summary
LC002 is an experimental therapeutic vaccine designed to boost the immune response of people infected with HIV. The purpose of this study was to determine the safety and tolerability of and immune response to LC002 in HIV-1-infected adults who are currently receiving anti-HIV treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With Primary Safety Endpoint |
0; 0; 0; 0 | — |
| SECONDARY Time-averaged Area Under the Curve (AUC) of CD4+ T-cell Count in PBMCs |
735.0; 1169.5; 745.0; 731.0 | — |
| SECONDARY Time-averaged AUC of CD8+ T-cell Count in PBMCs |
612.0; 1061.0; 686.0; 587.0 | — |
| SECONDARY Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by Taking the Mean of the Number of Spot-forming Cells/10^6 PBMCs Observed in Each PHPC Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev. |
16441.8; 25797.0; 920.1; 1760.4 | — |
| SECONDARY Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each PHPC Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev. |
18779.2; 6653.5; 1422.0; 3120.7; 15691.4; 33446.0 | — |
| SECONDARY Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by Taking the Mean of the Number of Spot-forming Cells/10^6 PBMCs Observed in Each ELISPOT Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev. |
421.8; 274.5; 214.2; 126.7 | — |
| SECONDARY Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each ELISPOT Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev. |
270.9; 186.5; 409.8; 152.6; 213.6; 458.4 | — |
| SECONDARY Anti-dsDNA Antibody Response |
5; 6; 6; 6 | — |
| SECONDARY Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev |
46.4; 21.5; 27.1; 13.0; 27.5; 9.2 | — |
| SECONDARY Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Whole HIV-1 Antigen |
305.3; 68.6; 4.6; 6.0 | — |
| SECONDARY Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3 |
333.6; 334.9; 200.4; 248.8 | — |
| SECONDARY Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev. |
10.0; 3.5; 4.9; 2.0; 4.3; 1.4 | — |
| SECONDARY Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Whole HIV-1 Antigen |
42.0; 10.6; 1.1; 0.9 | — |
| SECONDARY Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3 |
47.7; 37.4; 31.1; 48.5 | — |
| SECONDARY Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen. |
10.5; 11.1; 1.0; 2.5; 88.7; 59.1 | — |
| SECONDARY Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3 |
330.6; 486.2; 350.4; 278.9 | — |
| SECONDARY Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen. |
2.1; 0.7; 0.1; 0.5; 14.3; 4.8 | — |
| SECONDARY Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3 |
58.4; 54.3; 48.5; 53.5 | — |
| SECONDARY Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens |
1.2; 0.3; 0.1; 0; 0.7; 0 | — |
| SECONDARY Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens |
0.2; 0; 0; 0; 0.1; 0 | — |
| SECONDARY Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens |
0.4; 0.3; 0; 0; 3.1; 2.0 | — |
| SECONDARY Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens |
0; 0; 0; 0; 0.5; 0.2 | — |
| SECONDARY Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens |
0.6; 0.1; 0; 0; 0.1; 0 | — |
| SECONDARY Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens |
0.1; 0; 0; 0; 0; 0 | — |
| SECONDARY Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens |
0; 0.1; 0; 0.1; 0.3; 0.3 | — |
| SECONDARY Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens |
0; 0; 0; 0; 0.1; 0 | — |
| SECONDARY Lymphocyte Proliferation Stimulation Index (SI) in Response to Whole HIV-1 Antigen, p24 Antigen, and Pooled HIV-1 Peptide Antigens |
— | — |
Eligibility Criteria
Inclusion Criteria
- HIV-1-infected
- On a stable HAART regimen without changes or interruptions for more than 4 consecutive days for at least 12 weeks prior to study entry. Patients must be currently taking regimens containing drugs of at least two different classes.
- Two readings of plasma HIV-1 viral load of less than 50 copies/ml within 30 days prior to study entry. More information on this criterion can be found in the protocol.
- CD4 count greater than 350 cells/mm^3 within 12 weeks prior to study entry
- Lowest CD4 count greater than 250 cells/mm^3 at any time prior to study entry
- Willing to use acceptable forms of contraception
- Karnofsky performance score 90 or higher obtained within 30 days prior to study entry
Exclusion Criteria
- HIV-1 viral load greater than 500 copies/ml within the 24 weeks prior to study entry
- History of or current active skin disease (e.g., atopic dermatitis, psoriasis) or any chronic autoimmune disease (e.g., Graves' disease). Participants with minor, localized skin conditions that, in the opinion of the investigator, do not represent a safety concern, are not excluded.
- Treatment with topical corticosteroids at the proposed vaccination sites (Cohort 1: left and right upper back; Cohorts 2 and 3: left and right upper back and left and right upper ventral thigh) within 2 weeks of study entry
- Excessive exposure to the sun (e.g., sunbathing, tanning bed) within 2 weeks prior to study entry
- Laser hair removal within 2 weeks prior to study entry
- Use of any local skin treatments (e.g., topical/chemical hair removal, ointments, possible irritants) to the targeted vaccination sites within 7 days prior to study entry
- History of diabetes or bleeding disorders
- Previous CDC Category C event. More information on this criterion can be found in the protocol.
- Use of immunomodulating therapy, including cyclosporine, IgG-containing products, interleukins, interferons, or systemic glucocorticosteroids (including those inhaled) within 6 months prior to study entry
- Exposure to an experimental HIV vaccine within 6 months prior to study entry
- Any vaccine within 30 days prior to study entry
- Investigational products within 12 weeks prior to study entry
- Allergy or sensitivity to study vaccine products, adhesives, or polyester
- Current drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with the study
- Serious illness requiring systemic treatment and/or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
- Positive hepatitis B surface antigen or positive anti-hepatitis C antibody at screening
- History of treatment with HAART during primary infection
- History of lymph node irradiation
- Pregnant or breastfeeding
- Certain abnormal laboratory results. More information on this criterion can be found in the protocol
Data sourced from ClinicalTrials.gov (NCT00270205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.