A Phase 1 interventional study of 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 HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 9 sites in 2 countries. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment
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.
4,257 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 20 is below the median of 83 across 3,250 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
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Exclusion Criteria:
All participants in this study will receive two injections of the rMVA-HIV vaccine and the rFPV-HIV vaccine
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])
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
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
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)