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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
InnaVirVax
ClinicalTrials.gov Identifier:
NCT01549119
First received: March 2, 2012
Last updated: December 18, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: February 2012
Estimated Study Completion Date: July 2014
Primary Completion Date: November 2012 (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 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 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 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 3 vaccinations at one month apart

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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
Principal Investigator: Christine Katlama, MD Assistance Publique - Hôpitaux de Paris
  More Information

Additional Information:
No publications provided

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: December 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on October 16, 2014