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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01549119
First Posted: March 8, 2012
Last Update Posted: February 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
InnaVirVax
March 2, 2012
March 8, 2012
February 2, 2015
February 2012
February 2013   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01549119 on ClinicalTrials.gov Archive Site
  • Anti-3S antibody titers [ Time Frame: 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. [ Time Frame: from week 24 to week 60 ]
    Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load).
  • NKp44L expression on the surface of CD4+ T lymphocytes [ Time Frame: from D0 to week 60 ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase I/IIa Dose-escalation Clinical Study of VAC-3S
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
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV-1 Infection
  • Biological: 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
  • Biological: Placebo
    Comparison with experimental vaccine
  • Experimental: Low dose VAC-3S
    Intervention: Biological: VAC-3S
  • Experimental: Medium dose VAC-3S
    Intervention: Biological: VAC-3S
  • Experimental: High dose VAC-3S
    Intervention: Biological: VAC-3S
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
  • Experimental: Double-dose VAC-3S
    Intervention: Biological: VAC-3S
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
December 2014
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01549119
IVVAC-3S/P1
Yes
Not Provided
Not Provided
InnaVirVax
InnaVirVax
Not Provided
Study Director: Raphael Ho Tsong Fang, DVM, PHD InnaVirVax
InnaVirVax
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP