Clinical trial NCT02390466: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: HIV
Lead sponsor: InnaVirVax
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: From Day 0 to week 16
Secondary outcomes:
measure: 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.
timeFrame: From Week 16 to Week 48
measure: Anti-3S antibody titers
timeFrame: From Day 0 to Week 48
measure: Markers of progression to AIDS. Markers include CD4+ cell count, viral load, and phenotypic markers of lymphocyte differentiation and activation
timeFrame: From Day 0 to Week 48
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Cochin Saint Vincent de Paul
Study officials:
affiliation: InnaVirVax
name: Raphaël Ho Tsong Fang, DVM PhD
role: STUDY_DIRECTOR
References: