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

Phase 1

Completed

• Conditions: HIV-1 Infection
• Interventions: Biological: Placebo; Biological: VAC-3S

• Registration Number: NCT01549119
• Lead Sponsor: InnaVirVax

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-08
• Primary Completion: 2013-02
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-30
• Last Update Posted: 2015-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Medium dose VAC-3S	VAC-3S	-
High dose VAC-3S	VAC-3S	-
Double-dose VAC-3S	VAC-3S	-
Low dose VAC-3S	VAC-3S	-

Primary Outcome Measures

Name	Time	Method
Number of Study Participants Who Tolerated three vaccinations with VAC-3S at 4-weeks apart Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.	from D0 to week 24	Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load).

Secondary Outcome Measures

Name	Time	Method
NKp44L expression on the surface of CD4+ T lymphocytes	from D0 to week 60
Number of Study Participants Who Tolerated three vaccinations with VAC-3S at 4-weeks apart Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.	from week 24 to week 60	Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load).
Markers of progression to AIDS. Markers include CD4+ cell count, viral load, and phenotypic markers of lymphocyte differentiation and activation.	from D0 to week 60
Anti-3S antibody titers	from D0 to week 60

Trial Locations

Locations (2)

Hopital Pitie Salpetriere; 🇫🇷 Paris, France

CIC Cochin Pasteur; 🇫🇷 Paris, France