The purpose of this study is to evaluate the safety and tolerability of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Administered via intra-muscular injection in the arm
Hôpital Pitié Salpêtrière
Paris, France
Hôpital Cochin Saint Vincent de Paul
Paris, France
Number of patients who tolerated 3 vaccinations with VAC-3S 16µg/mL at 4-weeks interval determined by safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.
Time frame: From Day 0 to week 16
Number of patients who tolerated a fourth booster injection of VAC-3S 16µg/mL determined by safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.
Time frame: From Week 16 to Week 48
Anti-3S antibody titers
Time frame: From Day 0 to Week 48
Markers of progression to AIDS. Markers include CD4+ cell count, viral load, and phenotypic markers of lymphocyte differentiation and activation
Time frame: From Day 0 to Week 48
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