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30 treated chronic HIV-1 infected patients with CD4+ cell counts above 450 cells/ mm3 will be randomized 1:2 to receive placebo (n=10) or vaccine (n=20) at week 0, 4 and 16 and will be observed at the Investigation Unit of the study site for one hour following vaccination. At week 24 they will stop their HAART until the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine group | Experimental | Modified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef) (MVA HIV-B) |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccination | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| primary safety parameters | Grade 3 or above local adverse event (pain, cutaneous reactions including induration) Grade 3 or above systemic adverse event (temperature, chills, headache, nausea, vomiting, malaise, and myalgia) Grade 3 or above other clinical or laboratory adverse event confirmed at examination or on repeat testing respectively Any event attributable to vaccine leading to discontinuation of the immunisation regimen | week 8 |
| Primary immunogenicity parameters | Cellular responses - CD8/CD4+ T cell responses (ELISPOT) | After each inmunisation and at weeks 6-8 and 18-20 |
| Measure | Description | Time Frame |
|---|---|---|
| All grade 1 and 2 adverse events | week 8 | |
| Viral load rebound | After HAART interruption compared between both arms and with baseline viral load before any medication in each arm | week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08915 | Spain | ||
| Hospital Clinic i Provincial de Barcelona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26544853 | Derived | Gomez CE, Perdiguero B, Garcia-Arriaza J, Cepeda V, Sanchez-Sorzano CO, Mothe B, Jimenez JL, Munoz-Fernandez MA, Gatell JM, Lopez Bernaldo de Quiros JC, Brander C, Garcia F, Esteban M. A Phase I Randomized Therapeutic MVA-B Vaccination Improves the Magnitude and Quality of the T Cell Immune Responses in HIV-1-Infected Subjects on HAART. PLoS One. 2015 Nov 6;10(11):e0141456. doi: 10.1371/journal.pone.0141456. eCollection 2015. | |
| 25724985 |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D014611 | Vaccination |
| ID | Term |
|---|---|
| D016233 | Immunotherapy, Active |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
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| Placebo | Drug | 3 immunisations at week 0, 4 and 16 |
|
| Antibody responses |
| 48 weeks |
| Cellular responses | Intracellular cytokine analysis | Week 6 and 18 |
| Barcelona |
| Barcelona |
| 08036 |
| Spain |
| Hospital Universitario Gregorio Marañón | Madrid | Madrid | 28007 | Spain |
| Derived |
| Mothe B, Climent N, Plana M, Rosas M, Jimenez JL, Munoz-Fernandez MA, Puertas MC, Carrillo J, Gonzalez N, Leon A, Pich J, Arnaiz JA, Gatell JM, Clotet B, Blanco J, Alcami J, Martinez-Picado J, Alvarez-Fernandez C, Sanchez-Palomino S, Guardo AC, Pena J, Benito JM, Rallon N, Gomez CE, Perdiguero B, Garcia-Arriaza J, Esteban M, Lopez Bernaldo de Quiros JC, Brander C, Garcia F; RISVAC-03 Study Group. Safety and immunogenicity of a modified vaccinia Ankara-based HIV-1 vaccine (MVA-B) in HIV-1-infected patients alone or in combination with a drug to reactivate latent HIV-1. J Antimicrob Chemother. 2015;70(6):1833-42. doi: 10.1093/jac/dkv046. Epub 2015 Feb 26. |
| 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 |
| D001691 |
| Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |