Clinical Trials

MainTitle

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

This study has been completed
Sponsor
InnaVirVax


Information provided by (Responsible Party)
InnaVirVax
ClinicalTrials.gov Identifier
NCT01549119

First received: March 2, 2012
Last updated: January 30, 2015
Last Verified: January 2015
History of Changes
Purpose

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

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

Eligibility

Ages Eligible for Study: 18 Years to 55 Years  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Additional Information:

Sponsor's website

Responsible Party: InnaVirVax  
ClinicalTrials.gov Identifier: NCT01549119   History of Changes  
Other Study ID Numbers: IVVAC-3S/P1  
Study First Received: March 2, 2012  
Last Updated: January 30, 2015  

Keywords provided by InnaVirVax:

HIV-1
HIV
immunotherapy
active immunotherapy
vaccine
virulence
innate immunity
NK cells

Additional relevant MeSH terms:
Vaccines

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.