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

NCT01549119 | Completed Phase 1 DMC

• 1 other identifier: IVVAC-3S/P1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV-1 Infection

Keywords

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

Outcome Measures

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).

  from D0 to week 24

Secondary Outcomes (4)

• Anti-3S antibody titers

  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.

  from week 24 to week 60

• NKp44L expression on the surface of CD4+ T lymphocytes

  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.

  from D0 to week 60

Study Arms (5)

Low dose VAC-3S

EXPERIMENTAL

Biological: VAC-3S

Medium dose VAC-3S

EXPERIMENTAL

Biological: VAC-3S

High dose VAC-3S

EXPERIMENTAL

Biological: VAC-3S

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Double-dose VAC-3S

EXPERIMENTAL

Biological: VAC-3S

Interventions

VAC-3S BIOLOGICAL

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

Double-dose VAC-3S; High dose VAC-3S; Low dose VAC-3S; Medium dose VAC-3S

Placebo BIOLOGICAL

Comparison with experimental vaccine

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InnaVirVax: lead

Study Sites (2)

Hopital Pitie Salpetriere

Paris, 75013, France

Location

CIC Cochin Pasteur

Paris, 75014, France

Location

Related Links

• Sponsor's website

Study Officials

• Raphael Ho Tsong Fang, DVM, PHD

  InnaVirVax

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 8, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: December 1, 2014
• Last Updated: February 2, 2015

Record last verified: 2015-01

Locations

FR (2)