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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
InnaVirVax
ClinicalTrials.gov Identifier:
NCT02390466
First received: January 30, 2015
Last updated: June 16, 2016
Last verified: October 2015
  Purpose
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.

Condition Intervention Phase
HIV
Biological: VAC-3S
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentre, Open-label, Phase I/IIa Clinical Study of an Immunoprotective Therapeutic Vaccine Candidate (VAC-3S) in Human Immunodeficiency Virus Type 1 (HIV-1) Chronically Infected Patients Virologically Controlled on Antiretroviral Therapy (ART) Who Rose an Immune Response to VAC-3S During IVVAC-3S/P1

Resource links provided by NLM:


Further study details as provided by InnaVirVax:

Primary Outcome Measures:
  • 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. [ Time Frame: From Day 0 to week 16 ]

Secondary Outcome Measures:
  • 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. [ Time Frame: From Week 16 to Week 48 ]
  • Anti-3S antibody titers [ Time Frame: 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 [ Time Frame: From Day 0 to Week 48 ]

Estimated Enrollment: 15
Study Start Date: April 2015
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VAC-3S
32µg/ml corresponding to 16µg/vaccination
Biological: VAC-3S
Administered via intra-muscular injection in the arm

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system,
  • Any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise the safety of the patient or the ability to properly administer the study.
  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: NCT02390466

Locations
France
Hôpital Pitié Salpêtrière
Paris, France, 75013
Hôpital Cochin Saint Vincent de Paul
Paris, France, 75014
Sponsors and Collaborators
InnaVirVax
Investigators
Study Director: Raphaël Ho Tsong Fang, DVM PhD InnaVirVax
  More Information

Responsible Party: InnaVirVax
ClinicalTrials.gov Identifier: NCT02390466     History of Changes
Other Study ID Numbers: IVVAC-3S/P2
Study First Received: January 30, 2015
Last Updated: June 16, 2016

ClinicalTrials.gov processed this record on May 25, 2017