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Completed

NCT Number: NCT01549119

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

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.

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Key information

Conditions

HIV-1 Infection

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

CIC Cochin Pasteur, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VAC-3S

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

Biological

Comparison with experimental vaccine

Primary outcomes

  1. 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.

    Time frame: from D0 to week 24

    Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load).

Secondary outcomes

  1. Anti-3S antibody titers

    Time frame: from D0 to week 60

  2. 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.

    Time frame: from week 24 to week 60

    Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load).

  3. NKp44L expression on the surface of CD4+ T lymphocytes

    Time frame: from D0 to week 60

  4. Markers of progression to AIDS. Markers include CD4+ cell count, viral load, and phenotypic markers of lymphocyte differentiation and activation.

    Time frame: from D0 to week 60

Sponsors and collaborators

Lead sponsor

InnaVirVax

Industry

Registry information

Official study title

Multicentre, Randomized, Placebo-controlled, Double-blind, Phase I/IIa Dose-escalation Clinical Study of a Therapeutic Vaccine (VAC-3S) Intended to Confer Protection Against Immunopathological Effects of HIV-1 in Infected Patients

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Mar 8, 2012
Registry last updated
Feb 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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