The purpose of this study is to evaluate the protective effect of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
VAC-3S is administered via intra-muscular route in the arm.
Hôpital Sud Francilien
Corbeil-Essonne, France
Hôpital de la Croix Rousse
Lyon, France
Hôpital Gui de Chauliac
Montpellier, France
anti-3S antibodies titer
Time frame: From D0 to week 24
tolerance to 6 vaccinations of VAC-3S
safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) adverse events (AEs) grading table.Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load, CD4 and CD8 counts)
Time frame: From D0 to week 72
blood inflammatory marker concentrations
Inflammatory markers include: Highly sensitive C-reactive protein (hsCRP), Highly sensitive Recombinant human interleukin 6 (hsIL-6), Soluble CD14 (sCD14), Soluble CD163 (sCD163), D-dimer, Interferon (IFN)-gamma inducible protein 10 (IP-10), Tumor necrosis factor receptor 1 (sTNFR1) and 2 (sTNFR2), Immunoglobulin G (IgG),
Time frame: From D0 to week 72
immunogenic characteristics of VAC-3S
anti-3S antibody titers and determination of anti-3S antibody isotypes and avidity
Time frame: From D0 to week 72
lymphocyte phenotype markers
Phenotype markers include: Nkp44L expression on the surface of CD4+ T lymphocytes, phenotypic markers of of lymphocyte differentiation and activation
Time frame: From D0 to week 72
secondary virological effects
3S gp41 sequences and proviral HIV reservoir
Time frame: From D0 to week 72
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hôpital Saint-Antoine
Paris, France
Hôpital Pitié Salpêtrière
Paris, France
Hôpital Cochin Saint Vincent de Paul
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital Bichat - Claude Bernard
Paris, France
Hôpital Tenon
Paris, France
Jürgen Rockstroh
Bonn, Germany
...and 2 more locations