A Pilot Study to Investigate the Safety and Immunogenicity of a Peptide Vaccine for HIV Infected HLA-A2 Individuals Designed to Impede the Development of Antiretroviral Resistance
- Assess the safety of vaccination comprising E1M184V peptide with incomplete Freund's
adjuvant in combination with sargramostim (GM-CSF) in patients with HIV who are HLA-A2
- Assess, preliminarily, the ability of E1M184V peptide vaccine to induce a cytotoxic
T-cell response, defined by ELISPOT assay, in these patients.
- Explore, preliminarily, the effect of this regimen on HIV viral load and CD4 count in
- Explore, preliminarily, the development of lamivudine or emtricitabine resistance in
patients who subsequently receive lamivudine or emtricitabine.
- Explore, preliminarily, the ability of E1M184V peptide vaccine to induce a cytotoxic
T-cell response as assessed by HLA-A2 class I tetramers and intracellular interferon
gamma production after stimulation with E1M184V.
OUTLINE: This is a pilot study.
Patients receive vaccination comprising E1M184V peptide and incomplete Freund's adjuvant
subcutaneously (SC) on day 1 in weeks 0, 4, 8, 12, and 16. Patients also receive
sargramostim (GM-CSF) SC immediately after vaccination and once daily on days 1-4. Some
patients do not receive GM-CSF after the first 2 doses of vaccine. Treatment continues in
the absence of unacceptable toxicity.
Patients undergo blood collection at baseline and at 4, 12, 20, 36, and 52 weeks for
biomarker/laboratory analysis. Assays may include immunoenzyme techniques and viral
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Primary Purpose: Treatment
Impact of treatment on immune response, in terms of the difference between cytotoxic T-lymphocyte effector frequency, as measured by enzyme-linked immunospot (ELISPOT) at baseline and at week 20
Kathleen M. Wyvill, BSN, RN
NCI - HIV and AIDS Malignancy Branch
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|