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HIV InfectionsPhase 2NCT00272493

Safety and Effectiveness of an Adjuvant in Improving Immune Response to Hepatitis B Virus Vaccine in HIV Infected Individuals

A Phase 2 study testing Hepatitis B virus vaccine with GM-CSF adjuvant and Hepatitis B virus vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a naturally occurring substance that is made by the body in response to infection or inflammation, and greatly improves cellular immune responses. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Hepatitis B virus vaccine with GM-CSF adjuvant and Hepatitis B virus vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
11 sitesUnited States
Study dates
Start not givento Sep 2008
Phase
Phase 2
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

Who may be able to join

  • HIV infected
  • CD4 count of 200 cells/mm3 or more within 30 days prior to study entry
  • HIV-1 RNA viral load value obtained within 30 days prior to study entry
  • Received HAART for at least 8 weeks prior to study entry OR not on HAART within 8 weeks prior to study entry with no plans to start HAART during the study. Participants receiving HAART must be on stable therapy as defined by the protocol.
  • Negative hepatitis B core total antibody (HBcAb total), qualitative hepatitis B surface antibody (HBsAb), and hepatitis B surface antigen (HBsAg) tests within 30 days prior to study entry
  • Negative hepatitis C virus (HCV) antibody test, completed within 30 days prior to study entry
  • Willing to use acceptable forms of contraception

Who cannot join

  • HCV antibody or HCV RNA positive at any time prior to study entry
  • Previously vaccinated against HBV
  • Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, vaccines, interleukins, interferons, growth factors, or intravenous immune globulin within 30 days prior to study entry
  • Known allergy or sensitivity to any component of the study drugs
  • Active drug or alcohol dependence that would interfere with participation in the study
  • Any mental illness that may interfere with the study
Show all 10Show fewer
  • Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
  • Body weight less than 50 kg (110 lbs)
  • Abnormal lab values
  • Pregnant or breastfeeding

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Northwestern University CRS

    Chicago, Illinois, 60611-3015

  • Rush Univ. Med. Ctr. ACTG CRS

    Chicago, Illinois, 60611

  • Univ. of Cincinnati CRS

    Cincinnati, Ohio, 45267-0405

  • Case CRS

    Cleveland, Ohio, 44106-5083

  • MetroHealth CRS

    Cleveland, Ohio, 44109-1998

  • The Ohio State Univ. AIDS CRS

    Columbus, Ohio, 43210

  • Univ. of Rochester ACTG CRS

    Durham, North Carolina, 27710

  • NY Univ. HIV/AIDS CRS

    New York, New York, 10016-6481

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642-0001

  • University of Washington AIDS CRS

    Seattle, Washington, 98104

  • Washington U CRS

    St Louis, Missouri, 63108-2138

Other trials in United States

About this study

Official title: Improving Immune Response to Hepatitis B Vaccine in HIV-positive Subjects Using Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) as a Vaccine Adjuvant: A Phase II Open-Label Pilot Study

Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a naturally occurring substance that is made by the body in response to infection or inflammation, and greatly improves cellular immune responses. The purpose of this study is to evaluate the safety and effectiveness of GM-CSF as an adjuvant to improve the immune response to hepatitis B virus (HBV) vaccination in HIV infected individuals.

Read the detailed description

Highly active antiretroviral therapy (HAART) has greatly improved the life of HIV infected individuals. Before the introduction of HAART, the impact of HBV infection and liver disease was less prominent due to the rapid progression to AIDS. However, with the use of HAART, liver disease has become a leading cause of death in HIV infected individuals; therefore, prevention of HBV infection is essential. Most HIV infected people respond poorly to HBV vaccines. GM-CSF is a cytokine produced primarily by activated T and B cells and has been used extensively as a hematopoietic growth factor. GM-CSF increases neutrophil count, improves antigen-presenting cell function, and is involved in the development and improvement of cellular immune responses. Past research has shown that GM-CSF improves the immune response to HBV vaccination in people with kidney disease. The purpose of this study is to evaluate the safety and effectiveness of GM-CSF as an adjuvant to improve the immune response to HBV vaccination in HIV infected individuals.

This study will last 60 weeks. Participants will be randomly assigned to 1 of 2 arms. Arm A participants will receive 40 mcg of HBV vaccine at study entry, Week 4, and Week 12. Arm B participants will receive 40 mcg of HBV vaccine and 250 mcg of GM-CSF at study entry, Week 4, and Week 12. Participants will be stratified by their screening HIV-1 viral load. After completing the vaccination series, study visits will occur at Weeks 16, 36, and 60. Blood collection, a physical exam, and liver function and hepatitis antibody tests will be completed at all study visits. Telephone follow-up by study staff will occur 48 to 96 hours post-vaccination.

Conditions
HIV Infections
Being tested
Hepatitis B virus vaccine with GM-CSF adjuvant, Hepatitis B virus vaccine
Keywords
Treatment Experienced, Treatment Naive
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hepatitis B virus vaccine with GM-CSF adjuvantBiological

    Arm B participants will receive 40 mcg of HBV vaccine and 250 mcg of GM-CSF at study entry, Week 4, and Week 12.

  • Hepatitis B virus vaccineBiological

    Arm A participants will receive 40 mcg of HBV vaccine at study entry, Week 4, and Week 12.

Study groups in NCT00272493
Study groupRoleWhat they receive
AActive comparatorArm A participants will receive 40 mcg of HBV vaccine at study entry, Week 4, and Week 12.
Receives: Biological: Hepatitis B virus vaccine
BExperimentalArm B participants will receive 40 mcg of HBV vaccine and 250 mcg of GM-CSF at study entry, Week 4, and Week 12.
Receives: Biological: Hepatitis B virus vaccine with GM-CSF adjuvant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantitative hepatitis B surface antibody (HBsAb)

    Measured: At Week 16

  2. Occurrence of Grade 3 or higher adverse events (including hypersensitivity reaction) related to study regimens and HIV viral load increase greater than 1 log(10)

    Measured: Throughout the study

Secondary outcomes (6)

  1. Quantitative HBsAb 24 and 48 weeks after completion of HBV vaccination series

    Measured: At Weeks 36 and 60

  2. HBsAb response, defined as titer greater than 10 mlU/ml at 4, 24, and 48 weeks after completion of HBV vaccination series

    Measured: At Weeks 16, 36, and 60

  3. Changes in HIV viral load from baseline

    Measured: At Weeks 4, 16, and 60

  4. Changes in white blood cell and absolute neutrophil count from baseline

    Measured: At Weeks 4, 16, and 36

  5. Occurrence of Grade 2 or higher adverse events

    Measured: Throughout the study

  6. Changes in CD4 count from baseline

    Measured: At Weeks 4, 16, and 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2006 (estimated)
  2. Primary completionNov 2007
  3. Study completionSep 2008

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00272493
Sponsor's protocol ID
A5220
Other IDs
10148, ACTG A5220
Status last verified
May 2012
First submitted
4 Jan 2006
Last updated
25 Oct 2021
Results posted
No

Publications

  • Bica I, McGovern B, Dhar R, Stone D, McGowan K, Scheib R, Snydman DR. Increasing mortality due to end-stage liver disease in patients with human immunodeficiency virus infection. Clin Infect Dis. 2001 Feb 1;32(3):492-7. doi: 10.1086/318501. Epub 2001 Jan 23.

    PubMed 11170959

  • Laurence JC. Hepatitis A and B immunizations of individuals infected with human immunodeficiency virus. Am J Med. 2005 Oct;118 Suppl 10A:75S-83S. doi: 10.1016/j.amjmed.2005.07.024.

    PubMed 16271546

  • Sasaki Md, Foccacia R, de Messias-Reason IJ. Efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant for hepatitis B virus in patients with HIV infection. Vaccine. 2003 Nov 7;21(31):4545-9. doi: 10.1016/s0264-410x(03)00500-0.

    PubMed 14575766

  • Thio CL, Seaberg EC, Skolasky R Jr, Phair J, Visscher B, Munoz A, Thomas DL; Multicenter AIDS Cohort Study. HIV-1, hepatitis B virus, and risk of liver-related mortality in the Multicenter Cohort Study (MACS). Lancet. 2002 Dec 14;360(9349):1921-6. doi: 10.1016/s0140-6736(02)11913-1.

    PubMed 12493258

  • Overton ET, Kang M, Peters MG, Umbleja T, Alston-Smith BL, Bastow B, Demarco-Shaw D, Koziel MJ, Mong-Kryspin L, Sprenger HL, Yu JY, Aberg JA. Immune response to hepatitis B vaccine in HIV-infected subjects using granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant: ACTG study 5220. Vaccine. 2010 Aug 2;28(34):5597-604. doi: 10.1016/j.vaccine.2010.06.030. Epub 2010 Jun 23.

    PubMed 20600512

  • Anthony DD, Umbleja T, Aberg JA, Kang M, Medvik K, Lederman MM, Peters MG, Koziel MJ, Overton ET. Lower peripheral blood CD14+ monocyte frequency and higher CD34+ progenitor cell frequency are associated with HBV vaccine induced response in HIV infected individuals. Vaccine. 2011 Apr 27;29(19):3558-63. doi: 10.1016/j.vaccine.2011.02.092. Epub 2011 Mar 11.

    PubMed 21397720

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hepatitis B virus vaccine with GM-CSF adjuvant and Hepatitis B virus vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites 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?

The sponsor lists 7 inclusion and 10 exclusion criteria. 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 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Quantitative hepatitis B surface antibody (HBsAb) (time frame: At Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00272493, which also lists 6 linked publications.

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 25 Oct 2021.

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