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

NCT ID: NCT01549119

Last Updated: 2015-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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HIV-1 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low dose VAC-3S

Group Type EXPERIMENTAL

VAC-3S

Intervention Type BIOLOGICAL

Comparison of different doses of vaccine. Liquid form Volume: 0.5 mL - 2 X 0.5 mL for double-dose arm 3 vaccinations at one month apart

Medium dose VAC-3S

Group Type EXPERIMENTAL

VAC-3S

Intervention Type BIOLOGICAL

Comparison of different doses of vaccine. Liquid form Volume: 0.5 mL - 2 X 0.5 mL for double-dose arm 3 vaccinations at one month apart

High dose VAC-3S

Group Type EXPERIMENTAL

VAC-3S

Intervention Type BIOLOGICAL

Comparison of different doses of vaccine. Liquid form Volume: 0.5 mL - 2 X 0.5 mL for double-dose arm 3 vaccinations at one month apart

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Comparison with experimental vaccine

Double-dose VAC-3S

Group Type EXPERIMENTAL

VAC-3S

Intervention Type BIOLOGICAL

Comparison of different doses of vaccine. Liquid form Volume: 0.5 mL - 2 X 0.5 mL for double-dose arm 3 vaccinations at one month apart

Interventions

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VAC-3S

Comparison of different doses of vaccine. Liquid form Volume: 0.5 mL - 2 X 0.5 mL for double-dose arm 3 vaccinations at one month apart

Intervention Type BIOLOGICAL

Placebo

Comparison with experimental vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InnaVirVax

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raphael Ho Tsong Fang, DVM, PHD

Role: STUDY_DIRECTOR

InnaVirVax

Locations

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Hopital Pitie Salpetriere

Paris, , France

Site Status

CIC Cochin Pasteur

Paris, , France

Site Status

Countries

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France

Related Links

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http://www.innavirvax.fr

Sponsor's website

Other Identifiers

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IVVAC-3S/P1

Identifier Type: -

Identifier Source: org_study_id

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