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CompletedNCT01549119Updated Feb 2, 2015

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

A Phase 1/2 interventional study of VAC-3S and Placebo in HIV-1 Infection, sponsored by InnaVirVax. Completed at 2 sites in France. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-02-02.

Sponsored by InnaVirVax · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • HIV-1 Infection

Keywords

  • HIV-1
  • HIV
  • immunotherapy
  • active immunotherapy
  • vaccine
  • virulence
  • innate immunity
  • NK cells
03

In context

Lead sponsor

InnaVirVax is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Low dose VAC-3S

    Biological: VAC-3S

  • Experimental
    Medium dose VAC-3S

    Biological: VAC-3S

  • Experimental
    High dose VAC-3S

    Biological: VAC-3S

  • Placebo comparator
    Placebo

    Biological: Placebo

  • Experimental
    Double-dose VAC-3S

    Biological: VAC-3S

Interventions

  • BiologicalVAC-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

  • BiologicalPlacebo

    Comparison with experimental vaccine

06

What researchers measure

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.

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

    Time frame: from D0 to week 24

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.

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

    Time frame: from week 24 to week 60

  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

07

Study locations

2 sites
  • Hopital Pitie Salpetriere
    Paris, 75013, France
  • CIC Cochin Pasteur
    Paris, 75014, France
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01549119
Lead sponsor
InnaVirVax
Responsible party
Sponsor
First posted
Mar 8, 2012
Start date
Feb 2012
Primary completion
Feb 2013
Completion
Dec 2014
Last update
Feb 2, 2015

Study contacts

Raphael Ho Tsong Fang, DVM, PHD
study director · InnaVirVax

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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