Open-label, Phase I/IIa Study of VAC-3S in HIV-1 Patients Who Showed an Immune Response to VAC-3S During IVVAC-3S/P1
This trial is active, not recruiting.
|Phase||phase 1/phase 2|
|Start date||April 2015|
|End date||April 2017|
|Trial size||15 participants|
|Trial identifier||NCT02390466, IVVAC-3S/P2|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
32µg/ml corresponding to 16µg/vaccination
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
Male or female participants from 18 years up to 60 years old.
Inclusion Criteria: - HIV-1 infected patient, - Age between 18 and 60 years, - ART (Anti Retroviral Therapy) initiation ≥ 1 year ago, - Plasma HIV RNA ≤ 200 copies/ml in the past 12 months, - Plasma HIV RNA ≤ 50 copies/ml at the screening visit, - CD4+ T cell count ≥ 200 cells/mm3, - Nadir CD4+ T cell count ≥ 100 cells/mm3, - Contraception in women with child-bearing potential, - A total anti-3S titer ≥ 20 A.U. at any time point of IVVAC-3S/P1 clinical trial, - Per protocol subject having completed the IVVAC-3S/P1 study. - Patient affiliated to a social security system, - Patient who has understood the protocol design and provided a signed written informed consent form, - Patient who is willing and capable of cooperating to the extent and degree required by the protocol, - Patient whom the investigator believes he/she can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) and he/she will be available for all scheduled visits at the investigational site. Exclusion Criteria: - Administration of VAC-3S in the past year, - Chronic active liver disease, - History of HCV co-infection or ongoing replicating HCV (positive RT-PCR) or HBV (positive HbS Ag) coinfection, - Any immunotherapy (e.g. IL-2, IL-7, growth hormone…) in the past year at the exception of VAC-3S, - Any immunosuppressive therapy (glucocorticoids, cyclosporine, methotrexate) or chronic non-steroidal anti-inflammatory treatment in the past month, - Ongoing pregnancy, - Breastfeeding women, - Patient with known sensitivities to investigational drug (see please the CIB), - History of allergy to any vaccine, - Any severe chronic condition that would interfere with the study, - History of auto-immune disease, - Organ transplant, - Splenectomy, - Psychiatric disorder significant enough to hinder participation as assessed by the investigator, - Patient who has participated in a clinical research trial in the 30 days preceding the screening visit (V-1M-1). - Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system, - Any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise the safety of the patient or the ability to properly administer the study.
|Official title||Multicentre, Open-label, Phase I/IIa Clinical Study of an Immunoprotective Therapeutic Vaccine Candidate (VAC-3S) in Human Immunodeficiency Virus Type 1 (HIV-1) Chronically Infected Patients Virologically Controlled on Antiretroviral Therapy (ART) Who Rose an Immune Response to VAC-3S During IVVAC-3S/P1|
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