Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy
NCT ID: NCT00107549
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2009-02-28
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
All participants in this study will receive two injections of the rMVA-HIV vaccine and the rFPV-HIV vaccine
rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)])
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])
Recombinant experimental therapeutic vaccine using fowlpox vector given at Weeks 8 and 24
Interventions
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rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)])
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])
Recombinant experimental therapeutic vaccine using fowlpox vector given at Weeks 8 and 24
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
24 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Coleen K. Cunningham, MD
Role: STUDY_CHAIR
Pediatric Infectious Diseases, Duke University
Locations
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Children's Hospital Los Angeles NICHD CRS
Los Angeles, California, United States
Usc La Nichd Crs
Los Angeles, California, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Chicago Children's CRS
Chicago, Illinois, United States
Univ. of Maryland Baltimore NICHD CRS
Baltimore, Maryland, United States
Columbia IMPAACT CRS
New York, New York, United States
DUMC Ped. CRS
Durham, North Carolina, United States
St. Jude/UTHSC CRS
Memphis, Tennessee, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, , Puerto Rico
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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10051
Identifier Type: REGISTRY
Identifier Source: secondary_id
PACTG P1059
Identifier Type: -
Identifier Source: secondary_id
P1059
Identifier Type: -
Identifier Source: org_study_id