Open-label, Phase I/IIa Study of VAC-3S in HIV-1 Patients Who Showed an Immune Response to VAC-3S During IVVAC-3S/P1

NCT02390466 | Unknown Phase 1 DMC

• 1 other identifier: IVVAC-3S/P2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Number of patients who tolerated 3 vaccinations with VAC-3S 16µg/mL at 4-weeks interval determined by safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.

  From Day 0 to week 16

Secondary Outcomes (3)

• Number of patients who tolerated a fourth booster injection of VAC-3S 16µg/mL determined by safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.

  From Week 16 to Week 48

• Anti-3S antibody titers

  From Day 0 to Week 48

• Markers of progression to AIDS. Markers include CD4+ cell count, viral load, and phenotypic markers of lymphocyte differentiation and activation

  From Day 0 to Week 48

Study Arms (1)

VAC-3S

EXPERIMENTAL

32µg/ml corresponding to 16µg/vaccination

Biological: VAC-3S

Interventions

VAC-3S BIOLOGICAL

Administered via intra-muscular injection in the arm

VAC-3S

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HIV-1 infected patient,
• Age between 18 and 60 years,
• ART (Anti Retroviral Therapy) initiation ≥ 1 year ago,
• Plasma HIV RNA ≤ 200 copies/ml in the past 12 months,
• Plasma HIV RNA ≤ 50 copies/ml at the screening visit,
• CD4+ T cell count ≥ 200 cells/mm3,
• Nadir CD4+ T cell count ≥ 100 cells/mm3,
• Contraception in women with child-bearing potential,
• A total anti-3S titer ≥ 20 A.U. at any time point of IVVAC-3S/P1 clinical trial,
• Per protocol subject having completed the IVVAC-3S/P1 study.
• Patient affiliated to a social security system,
• Patient who has understood the protocol design and provided a signed written informed consent form,
• Patient who is willing and capable of cooperating to the extent and degree required by the protocol,
• Patient whom the investigator believes he/she can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) and he/she will be available for all scheduled visits at the investigational site.

You may not qualify if:

• Administration of VAC-3S in the past year,
• Chronic active liver disease,
• History of HCV co-infection or ongoing replicating HCV (positive RT-PCR) or HBV (positive HbS Ag) coinfection,
• Any immunotherapy (e.g. IL-2, IL-7, growth hormone…) in the past year at the exception of VAC-3S,
• Any immunosuppressive therapy (glucocorticoids, cyclosporine, methotrexate) or chronic non-steroidal anti-inflammatory treatment in the past month,
• Ongoing pregnancy,
• Breastfeeding women,
• Patient with known sensitivities to investigational drug (see please the CIB),
• History of allergy to any vaccine,
• Any severe chronic condition that would interfere with the study,
• History of auto-immune disease,
• Organ transplant,
• Splenectomy,
• Psychiatric disorder significant enough to hinder participation as assessed by the investigator,
• Patient who has participated in a clinical research trial in the 30 days preceding the screening visit (V-1M-1).

Sponsors & Collaborators

• InnaVirVax: lead

Study Sites (2)

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Hôpital Cochin Saint Vincent de Paul

Paris, 75014, France

Location

Study Officials

• Raphaël Ho Tsong Fang, DVM PhD

  InnaVirVax

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: March 17, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 17, 2016

Record last verified: 2015-10

Locations

FR (2)