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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
30
* Modified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef) -\~ 1 x 10e8 pfu/ml * 3 immunisations at week 0, 4 and 16
3 immunisations at week 0, 4 and 16
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, Spain
Hospital Universitario Gregorio Marañón
Madrid, Madrid, Spain
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
Time frame: week 8
Primary immunogenicity parameters
Cellular responses - CD8/CD4+ T cell responses (ELISPOT)
Time frame: After each inmunisation and at weeks 6-8 and 18-20
All grade 1 and 2 adverse events
Time frame: week 8
Viral load rebound
After HAART interruption compared between both arms and with baseline viral load before any medication in each arm
Time frame: week 48
Antibody responses
* binding titration to the construct MVAB * binding titration to and neutralisation of vaccinia
Time frame: 48 weeks
Cellular responses
Intracellular cytokine analysis
Time frame: Week 6 and 18
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