Phase I/IIa Dose-escalation Clinical Study of VAC-3S

InnaVirVax

Status and phase: Completed; Phase 2; Phase 1

Conditions: HIV-1 Infection

Treatments: Biological: Placebo; Biological: VAC-3S

Study type: Interventional

Funder types: Industry

Identifiers

NCT01549119

IVVAC-3S/P1

Details and patient eligibility

About

The purpose of this trial is to evaluate the safety and immunogenicity of the therapeutic vaccine candidate VAC-3S in HIV-1 infected patients under AntiRetroviral Therapy (ART) with undetectable viral loads.

Enrollment: 33 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV-1 infected patient
• Age between 18 and 55 years
• ART (AntiRetroviral Therapy) initiation 1 year ago
• Plasma HIV RNA below 50 copies per ml on three sequential occasions including V-1 in the past 12 months
• CD4 T cell count above or equal to 200 cells per mm3,
• Nadir CD4 T cell count above or equal to 100 cells per mm3,
• Contraception in women with child-bearing potential

Exclusion criteria

• Any ART change within a month preceding screening.
• Chronic active liver disease, HIV-Hepatitis Coinfection.
• Immunotherapy in the past year, immunosuppressive treatment within the past month.
• History of auto-immune disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 5 patient groups, including a placebo group

Low dose VAC-3S

Experimental group

Treatment:

Biological: VAC-3S

Medium dose VAC-3S

Experimental group

Treatment:

Biological: VAC-3S

High dose VAC-3S

Experimental group

Treatment:

Biological: VAC-3S

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo

Double-dose VAC-3S

Experimental group

Treatment:

Biological: VAC-3S