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| ID | Type | Description | Link |
|---|---|---|---|
| 10051 | Registry Identifier | DAIDS ES Registry Number | |
| PACTG P1059 |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | All participants in this study will receive two injections of the rMVA-HIV vaccine and the rFPV-HIV vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Development of any adverse events of Grade 3 or higher | Throughout study | |
| Development of adverse events of Grade 3 or higher attributed to the study vaccines | Throughout study | |
| Viral breakthrough to greater than 1,000 copies/ml | During the first 24 weeks of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Coleen K. Cunningham, MD | Pediatric Infectious Diseases, Duke University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles NICHD CRS | Los Angeles | California | 90027 | United States | ||
| Usc La Nichd Crs |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15544457 | Background | 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. | |
| 14604567 | Background | 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. |
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| 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 |
|
| Los Angeles |
| California |
| 90033 |
| United States |
| Univ. of Colorado Denver NICHD CRS | Aurora | Colorado | 80218-1088 | United States |
| Chicago Children's CRS | Chicago | Illinois | 60614 | 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 | 38105-2794 | United States |
| Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS | San Juan | Puerto Rico |
| 9811759 | Background | 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. |
| 15039533 | Background | 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. |
| 15544450 | Background | 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. |
| 19605490 | Derived | 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. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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