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Trial record 1 of 1 for:    IVVAC-3S/P2
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02390466
Recruitment Status : Unknown
Verified October 2015 by InnaVirVax.
Recruitment status was:  Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
InnaVirVax

Tracking Information
First Submitted Date  ICMJE January 30, 2015
First Posted Date  ICMJE March 17, 2015
Last Update Posted Date June 17, 2016
Study Start Date  ICMJE April 2015
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2016)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
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 48 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
  • 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 Day 0 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV
Intervention  ICMJE Biological: VAC-3S
Administered via intra-muscular injection in the arm
Study Arms  ICMJE Experimental: VAC-3S
32µg/ml corresponding to 16µg/vaccination
Intervention: Biological: VAC-3S
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 10, 2015)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2017
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02390466
Other Study ID Numbers  ICMJE IVVAC-3S/P2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InnaVirVax
Study Sponsor  ICMJE InnaVirVax
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Raphaël Ho Tsong Fang, DVM PhD InnaVirVax
PRS Account InnaVirVax
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP