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.

InnaVirVax0 个研究点开始时间: 2015年6月23日最近更新: 2015年7月10日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•- HIV-1 infected patient
•- Age between 18 and 60 years
•- ART (AntiRetroviral Therapy) initiation ? 1 year ago
•- Plasma HIV RNA < 100 copies/ml in the past 12 months
•- CD4+ T cell count = 200 cells/mm3,
•- Nadir CD4+ T cell count = 100 cells/mm3,
•- Female patient of childbearing potential with a negative urine pregnancy test (UPT). Females of non-childbearing potential, i.e., post-menopausal (absence of menstrual bleeding for 1 year, or 6 months with laboratory confirmation of hormonal status), hysterectomy or bilateral oophorectomy, are not required a UPT,
•- Female patient of childbearing potential under highly effective contraception defined as two of the following methods of contraception and willing to have two of them for the entire study duration: masculine or feminine condom use, bilateral tubal ligation, intra-uterine device (IUD), oral, transdermal, systemic or implant contraception on a stable dose for at least 3 months,
•- 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Chronic active liver disease,
•2. History of HCV co-infection or ongoing replicating HCV (positive RT-PCR) or HBV (positive HbS Ag) coinfection,
•3. Any immunotherapy (e.g. IL-2, IL-7, growth hormone…) in the past year at the exception of VAC-3S,
•4. Any immunosuppressive therapy (glucocorticoids, cyclosporine, methotrexate) or chronic non-steroidal anti-inflammatory treatment in the past month,
•5. Ongoing pregnancy,
•6. Breastfeeding women,
•7. Patient with known sensitivities to investigational drug (see please the CIB),
•8. History of allergy to any vaccine,
•9. Any severe chronic condition that would interfere with the study,
•10. History of auto-immune disease,
•11. Organ transplant,
•12. Splenectomy,
•13. Psychiatric disorder significant enough to hinder participation as assessed by the investigator,
•14. Patient who has participated in a clinical research trial in the 30 days preceding the screening visit (V-1M-1).
•15. Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system,
•16. 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.

研究者

发起方

InnaVirVax

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