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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
  Purpose
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.

Condition Intervention Phase
HIV-1 Infection Biological: VAC-3S Biological: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by InnaVirVax:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 33
Study Start Date: February 2012
Study Completion Date: December 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose VAC-3S 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
Experimental: Medium dose VAC-3S 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
Experimental: High dose VAC-3S 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
Placebo Comparator: Placebo Biological: Placebo
Comparison with experimental vaccine
Experimental: Double-dose VAC-3S 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549119


Locations
France
Hopital Pitie Salpetriere
Paris, France, 75013
CIC Cochin Pasteur
Paris, France, 75014
Sponsors and Collaborators
InnaVirVax
Investigators
Study Director: Raphael Ho Tsong Fang, DVM, PHD InnaVirVax
  More Information

Additional Information:
Responsible Party: InnaVirVax
ClinicalTrials.gov Identifier: NCT01549119     History of Changes
Other Study ID Numbers: IVVAC-3S/P1
First Submitted: March 2, 2012
First Posted: March 8, 2012
Last Update Posted: February 2, 2015
Last Verified: January 2015

Keywords provided by InnaVirVax:
HIV-1
HIV
immunotherapy
active immunotherapy
vaccine
virulence
innate immunity
NK cells

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs


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