Nonneoplastic ConditionPhase 1NCT00381875
Vaccine Therapy, Incomplete Freund's Adjuvant, and GM-CSF in Treating Patients With HIV
A Phase 1 study testing E1M184V peptide vaccine, incomplete Freund's adjuvant and sargramostim in people with Nonneoplastic Condition, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response. Incomplete Freund's adjuvant may stimulate the immune system in different ways and may help the vaccine work better. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonneoplastic Condition
- What is being tested?
- E1M184V peptide vaccine, incomplete Freund's adjuvant and sargramostim
- Type of treatment
- Vaccines
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Feb 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- HIV-1 infection confirmed by Western blot and enzyme-linked immunosorbent assay
- HLA-A2 positive by polymerase chain reaction-sequence specific primers
- CD4 T-cell count ≥ 300/mm³
- Must be receiving stable regimen of highly active antiretroviral therapy (HAART) that does not include lamivudine or emtricitabine for ≥ 1 month prior to study entry
- Patients on HAART, including lamivudine or emtricitabine, for which there is a medically appropriate regimen that does not include lamivudine or emtricitabine, are eligible if willing to change antiretrovirals
- Viral load < 50 copies/mL for 1 month prior to study entry
PATIENT CHARACTERISTICS:
- See Disease Characteristics
- ECOG performance status 0-1
- Life expectancy ≥ 6 months
- Hemoglobin ≥ 9 g/dL
- WBC ≥ 1,000/mm³
- Absolute neutrophil count ≥ 750/mm³
- Platelet count ≥ 75,000/mm³
- PT and PTT ≤ 120% of control unless lupus anticoagulant detected
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 7.5 mg/dL with direct fraction ≤ 0.7 mg/dL if on protease inhibitor therapy or due to Gilbert's syndrome)
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No hepatitis B surface antigen (HBsAg) or a prior history of HBsAg while on lamivudine or emtricitabine
- Prior treatment with tenofovir and currently HBsAg negative allowed
- No evidence of a severe or life-threatening infection other than HIV within the past 6 months
- No opportunistic infections requiring systemic therapy within the past month
- No active malignancy, except for basal cell carcinoma
- No known hypersensitivity to incomplete Freund's adjuvant or incomplete Freund's adjuvant VG (vegetable-grade), E1M184V peptide, or sargramostim (GM-CSF)
- No other abnormality that would be scored as ≥ grade 3 toxicity, except any of the following (if asymptomatic):
- Hyperuricemia of grade 4 (without physiologic consequences)
- Elevation of lactate dehydrogenase ≥ grade 3
- Elevation of creatine phosphokinase (CPK) ≥ grade 3
- Hypophosphatemia ≥ grade 3 (if patient is on tenofovir)
- Elevation of alkaline phosphate of grade 3
- Hyperamylasemia of ≥ grade 3 allowed if any of the following criteria are met:
- Macroamylasemia
- Lipase ≤ 2 times ULN
- Lymphopenia grade 3
- No other condition that, in the opinion of the investigator, would preclude compliance with study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No systemic corticosteroids within the past 3 weeks
- Concurrent systemic corticosteroids allowed in the short term only
- Physiologic replacement doses of steroids allowed
- No prior vaccination with a vaccine that includes all or part of the reverse transcriptase of HIV-1
- No other concurrent investigational drugs or vaccinations
- No concurrent lamivudine or emtricitabine
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, 20892-1182
About this study
Official title: 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
RATIONALE: Vaccines made from peptides may help the body build an effective immune response. Incomplete Freund's adjuvant may stimulate the immune system in different ways and may help the vaccine work better. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with incomplete Freund's adjuvant and GM-CSF may be an effective treatment for patients with HIV.
PURPOSE: This clinical trial is studying how well giving vaccine therapy together with incomplete Freund's adjuvant and GM-CSF works in treating patients with HIV.
Read the detailed description
OBJECTIVES:
Primary
- 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 positive.
- Assess, preliminarily, the ability of E1M184V peptide vaccine to induce a cytotoxic T-cell response, defined by ELISPOT assay, in these patients.
Secondary
- Explore, preliminarily, the effect of this regimen on HIV viral load and CD4 count in these patients.
- 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 genotyping.
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.
- Conditions
- Nonneoplastic Condition
- Being tested
- E1M184V peptide vaccine, incomplete Freund's adjuvant, sargramostim, immunoenzyme technique
- Keywords
- HIV infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E1M184V peptide vaccineBiological
incomplete Freund's adjuvantBiological
sargramostimBiological
immunoenzyme techniqueOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (3)
Effects of treatment on viral load
Sequencing of any resultant HIV strains
CD4 counts for assessment of effects on HIV disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startJul 2006
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonneoplastic ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Kathleen M. Wyvill, BSN, RN, NCI - HIV and AIDS Malignancy Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381875
- Sponsor's protocol ID
- 060211
- Other IDs
- 06-C-0211, NCI-P6066, NCI-6958, CDR0000495768
- Status last verified
- May 2012
- First submitted
- 26 Sep 2006
- Last updated
- 2 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00381875
- Acronym / sponsor ID
- 060211
- Conditions
- Nonneoplastic Condition
- Keywords
- HIV infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2006
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 28 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Vaccines made from peptides may help the body build an effective immune response. Incomplete Freund's adjuvant may stimulate the immune system in different ways and may help the vaccine work better. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with incomplete Freund's adjuvant and GM-CSF may be an effective treatment for patients with HIV.
PURPOSE: This clinical trial is studying how well giving vaccine therapy together with incomplete Freund's adjuvant and GM-CSF works in treating patients with HIV.
Detailed description
OBJECTIVES:
Primary
- 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 positive.
- Assess, preliminarily, the ability of E1M184V peptide vaccine to induce a cytotoxic T-cell response, defined by ELISPOT assay, in these patients.
Secondary
- Explore, preliminarily, the effect of this regimen on HIV viral load and CD4 count in these patients.
- 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 genotyping.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E1M184V peptide vaccine | Biological | – |
| incomplete Freund's adjuvant | Biological | – |
| sargramostim | Biological | – |
| immunoenzyme technique | Other | – |
Primary outcome
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
3 secondary outcomes
Effects of treatment on viral load
Sequencing of any resultant HIV strains
CD4 counts for assessment of effects on HIV disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M. Wyvill, BSN, RN
NCI - HIV and AIDS Malignancy Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E1M184V peptide vaccine, incomplete Freund's adjuvant and sargramostim in people with Nonneoplastic Condition, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2012.