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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Recombinant experimental therapeutic vaccine using the modified vaccinia Ankara vector given at study entry and Week 4
Recombinant experimental therapeutic vaccine using fowlpox vector given at Weeks 8 and 24
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
Development of any adverse events of Grade 3 or higher
Time frame: Throughout study
Development of adverse events of Grade 3 or higher attributed to the study vaccines
Time frame: Throughout study
Viral breakthrough to greater than 1,000 copies/ml
Time frame: During the first 24 weeks of study
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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