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HIV InfectionsPhase 1NCT00107549

Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy

A Phase 1 study testing rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)]) and rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349]) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in 2 countries.

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

The purpose of this study is to determine the safety of two recombinant HIV vaccines in HIV infected young adults on stable anti-HIV therapy. Read more about this study

Who is it for?
Ages 18 to 24 years
Conditions the study is for
HIV Infections
What is being tested?
rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)]) and rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349])
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
9 sitesin 2 countries
Study dates
Start not givento Feb 2009
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 to 24 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • HIV-1 infected
  • CD4 count of 350 cells/mm3 or greater
  • If hepatitis B or C infected, infection must be chronic and stable
  • Normal electrocardiogram (ECG)
  • On stable HAART consisting of at least 3 different antiretrovirals from 2 different classes AND with a viral load of less than 100 copies/ml for at least 6 months prior to study entry
  • Willing to use acceptable forms of contraception. Females enrolled in the study must use contraception for at least 21 days prior to first vaccination until the last study visit. Males enrolled in the study must use a condom from the first vaccination until one month after the last vaccination.
  • Willing to follow all study requirements
  • Available for follow-up for the duration of the study

Who cannot join

  • History of allergic reaction to eggs or egg products
  • Known hypersensitivity to vaccine components
  • Chemotherapy for active cancer in the 12 months prior to study entry
  • Prior vaccination with any HIV-1 vaccine
  • Prior vaccination against smallpox
  • Prior vaccinia immunization
Show all 14Show fewer
  • Any immunization within 1 month of study screening
  • History of or known active heart disease including myocardial infarction, angina pectoris, congestive heart failure, cardiomyopathy, pericarditis, stroke or transient ischemic attack, chest pain or shortness of breath with activity such as walking upstairs, mitral valve prolapse, or other heart conditions under a doctor's care
  • Immunomodulatory agents, gamma globulin, or investigational agents within 6 months of study entry
  • Systemic steroids, including nonprescription street steroids, within 6 months of study entry
  • Documented or suspected serious bacterial infection, metabolic illness, cancer, or immediate life-threatening condition
  • Any clinically significant diseases other than HIV infection or clinically significant findings during study screening that, in the investigator's opinion, may interfere with the study
  • Current alcohol or drug abuse that, in the investigator's opinion, may interfere with the study
  • Pregnancy or breastfeeding

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

United States8 sites

  • Univ. of Colorado Denver NICHD CRS

    Aurora, Colorado, 80218-1088

  • Univ. of Maryland Baltimore NICHD CRS

    Baltimore, Maryland

  • Chicago Children's CRS

    Chicago, Illinois, 60614

  • DUMC Ped. CRS

    Durham, North Carolina

  • Children's Hospital Los Angeles NICHD CRS

    Los Angeles, California, 90027

  • Usc La Nichd Crs

    Los Angeles, California, 90033

  • St. Jude/UTHSC CRS

    Memphis, Tennessee, 38105-2794

  • Columbia IMPAACT CRS

    New York, New York

Other trials in United States

Puerto Rico1 site

  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Phase I, Open-Label Study to Evaluate the Safety and Tolerability of Recombinant HIV-1 Vaccines in HIV-1 Infected Young Adults With Control of HIV-1 Replication and on Stable Highly Active Antiretroviral Therapy (HAART)

The purpose of this study is to determine the safety of two recombinant HIV vaccines in HIV infected young adults on stable anti-HIV therapy.

Read the detailed description

By helping to control viral replication, HAART has dramatically improved the prognosis for HIV infected individuals. However, because of extensive side effects, some of which may be acute and life-threatening, many patients find it difficult to tolerate a HAART regimen. HAART-associated long-term morbidity or mortality contribute to this difficulty. Administering an HIV therapeutic vaccine might allow HIV infected individuals to delay or interrupt treatment, avoiding the side effects associated with antiretroviral exposure. This study will evaluate the safety of two injections of two recombinant therapeutic vaccines in HIV infected young adults who are currently on stable HAART.

This study will last 72 weeks. All participants will receive two rMVA vaccines (env/gag and tat/rev/nef-RT) at study entry and at Week 4 and two rFPV vaccines (env/gag and tat/rev/nef-RT) at Weeks 8 and 24. Safety will be assessed immediately after each immunization and at 1 hour and 48 hours postimmunization. There will be 16 study visits over 72 weeks. A physical exam, blood collection, and administration of an adherence module will occur at most visits. An electrocardiogram (ECG) will occur at study entry and Weeks 2 and 10. Urine collection will occur at study entry and Weeks 4, 8, and 24.

Conditions
HIV Infections
Being tested
rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)]), rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349])
Keywords
Treatment Experienced, HIV Therapeutic Vaccine
Medical subject headings
HIV Infections

What participants receive

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

  • rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)])Biological

    Recombinant experimental therapeutic vaccine using the modified vaccinia Ankara vector given at study entry and Week 4

  • rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349])Biological

    Recombinant experimental therapeutic vaccine using fowlpox vector given at Weeks 8 and 24

Study groups in NCT00107549
Study groupRoleWhat they receive
1ExperimentalAll participants in this study will receive two injections of the rMVA-HIV vaccine and the rFPV-HIV vaccine
Receives: Biological: rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)]); Biological: rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349])

What is being measured

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

  1. Development of any adverse events of Grade 3 or higher

    Measured: Throughout study

  2. Development of adverse events of Grade 3 or higher attributed to the study vaccines

    Measured: Throughout study

  3. Viral breakthrough to greater than 1,000 copies/ml

    Measured: During the first 24 weeks of study

Timeline

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

  1. First posted6 Apr 2005 (estimated)
  2. Study completionFeb 2009

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00107549
Sponsor's protocol ID
P1059
Other IDs
10051, PACTG P1059
Status last verified
Oct 2021
First submitted
5 Apr 2005
Last updated
1 Nov 2021
Results posted
No

Publications

  • Caputo A, Gavioli R, Ensoli B. Recent advances in the development of HIV-1 Tat-based vaccines. Curr HIV Res. 2004 Oct;2(4):357-76. doi: 10.2174/1570162043350986.

    PubMed 15544457

  • Cosma A, Nagaraj R, Buhler S, Hinkula J, Busch DH, Sutter G, Goebel FD, Erfle V. Therapeutic vaccination with MVA-HIV-1 nef elicits Nef-specific T-helper cell responses in chronically HIV-1 infected individuals. Vaccine. 2003 Dec 8;22(1):21-9. doi: 10.1016/s0264-410x(03)00538-3.

    PubMed 14604567

  • Kent SJ, Zhao A, Best SJ, Chandler JD, Boyle DB, Ramshaw IA. Enhanced T-cell immunogenicity and protective efficacy of a human immunodeficiency virus type 1 vaccine regimen consisting of consecutive priming with DNA and boosting with recombinant fowlpox virus. J Virol. 1998 Dec;72(12):10180-8. doi: 10.1128/JVI.72.12.10180-10188.1998.

    PubMed 9811759

  • Mwau M, Cebere I, Sutton J, Chikoti P, Winstone N, Wee EG, Beattie T, Chen YH, Dorrell L, McShane H, Schmidt C, Brooks M, Patel S, Roberts J, Conlon C, Rowland-Jones SL, Bwayo JJ, McMichael AJ, Hanke T. A human immunodeficiency virus 1 (HIV-1) clade A vaccine in clinical trials: stimulation of HIV-specific T-cell responses by DNA and recombinant modified vaccinia virus Ankara (MVA) vaccines in humans. J Gen Virol. 2004 Apr;85(Pt 4):911-919. doi: 10.1099/vir.0.19701-0.

    PubMed 15039533

  • Pancharoen C, Ananworanich J, Thisyakorn U. Immunization for persons infected with human immunodeficiency virus. Curr HIV Res. 2004 Oct;2(4):293-9. doi: 10.2174/1570162043351084.

    PubMed 15544450

  • Shiu C, Cunningham CK, Greenough T, Muresan P, Sanchez-Merino V, Carey V, Jackson JB, Ziemniak C, Fox L, Belzer M, Ray SC, Luzuriaga K, Persaud D; Pediatric AIDS Clinical Trials Group P1059 Team. Identification of ongoing human immunodeficiency virus type 1 (HIV-1) replication in residual viremia during recombinant HIV-1 poxvirus immunizations in patients with clinically undetectable viral loads on durable suppressive highly active antiretroviral therapy. J Virol. 2009 Oct;83(19):9731-42. doi: 10.1128/JVI.00570-09. Epub 2009 Jul 15.

    PubMed 19605490

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)]) and rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349]) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in 2 countries.

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 8 inclusion and 14 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Puerto Rico. 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?

Development of any adverse events of Grade 3 or higher (time frame: Throughout study). The study lists 3 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 NCT00107549, 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 1 Nov 2021.

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