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

NCT ID: NCT02390466

Last Updated: 2016-06-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-04-30

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.

Conditions

HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VAC-3S

32µg/ml corresponding to 16µg/vaccination

Group Type: EXPERIMENTAL

VAC-3S

Intervention Type: BIOLOGICAL

Administered via intra-muscular injection in the arm

Interventions

VAC-3S

Administered via intra-muscular injection in the arm

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InnaVirVax

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raphaël Ho Tsong Fang, DVM PhD

Role: STUDY_DIRECTOR

InnaVirVax

Locations

Hôpital Pitié Salpêtrière

Paris, , France

Hôpital Cochin Saint Vincent de Paul

Paris, , France

Countries

France

Other Identifiers

IVVAC-3S/P2

Identifier Type: -

Identifier Source: org_study_id