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

HIV-1 Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549119
• Other study ID #: IVVAC-3S/P1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 2, 2012
• Last updated: January 30, 2015
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: InnaVirVax
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

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
Comparison with experimental vaccine

Locations

Country	Name	City	State
France	CIC Cochin Pasteur	Paris
France	Hopital Pitie Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
InnaVirVax

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anti-3S antibody titers		from D0 to week 60
Secondary	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 week 24 to week 60
Secondary	NKp44L expression on the surface of CD4+ T lymphocytes		from D0 to week 60
Secondary	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

External Links

•   Sponsor's website