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

InnaVirVax

Status and phase

Unknown

Phase 2

Phase 1

Conditions

HIV

Treatments

Biological: VAC-3S

Study type

Interventional

Funder types

Industry

Identifiers

NCT02390466

IVVAC-3S/P2

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.